National Drug Policy and Authority Act

Chapter 198

National Drug Policy and Authority Act

This is the latest version of this Statute.

Citation

Chapter 198

Date

Language

English

National Drug Policy and Authority Act

Chapter 198

Commenced on 3 December 1993
[This is the version of this document at 31 December 2023.]
[Note: This legislation was revised and consolidated as at 31 December 2000 and 31 December 2023 by the Law Reform Commission of Uganda. All subsequent amendments have been researched and applied by Laws.Africa for ULII.]

[Amended by Narcotic Drugs and Psychotropic Substances (Control) Act (Act 3 of 2016) on 15 February 2016]
[Amended by Law Revision (Miscellaneous Amendments) Act, 2023 (Act 17 of 2023) on 28 July 2023]

An Act to provide for the establishment of the National Drug Policy and the National Drug Authority to ensure the availability, at all times, of essential, efficacious and cost-effective drugs to the entire population of Uganda, as a means of providing satisfactory health care and safeguarding the appropriate use of drugs.[Statute 13/1993; S.I. 31/1999; Cap. 206 (Revised Edition, 2000); S.I. 76/2019; S.I. 10/2021; Act 17/2023; Act 2/2024]

Part I – Interpretation

1. Interpretation

In this Act, unless the context otherwise requires—"advertisement" includes any notice, circular, label, wrapper or other document, and any announcement made orally or by means of producing or transmitting light or sound;“approved institution” includes gazetted hospitals, health centres, dispensaries, aid posts, registered medical clinics and nursing homes;“authorised person” means a person authorised under this Act;“authorised pharmacopoeia” means the current edition for the time being of any of the following, namely, the International Pharmacopoeia, the British Pharmacopoeia, the British Pharmaceutical Codex, the European Pharmacopoeia, the United States Pharmacopoeia and the British Veterinary Codex;“Class A drug”, “Class B drug” and “Class C drug” shall be construed in accordance with section 12;“classified drug” means a Class A, B or C drug;“Commission” means the National Drug Authority Commission;“currency point” has the value assigned to it in Schedule 1 to this Act;“descriptive matter” means any statement, whether written or oral, which purports to describe the composition or effect of any drug; and references to the publication of descriptive matter shall be references to its publication by way of advertisement, or on or with the container in which the drug is supplied or in any other manner;“disease” includes injury and bodily or mental deficiency or abnormality;“dispense”, in relation to a medicine or poison, means to supply a medicine or poison on and in accordance with a prescription duly given by a duly qualified medical practitioner, dentist or veterinary surgeon;“drug” means any substance or preparation used or intended to be used for internal or external application to the human or animal body either in the treatment or prevention of disease or for improving physiological functions, or for agricultural or industrial purposes;“Drug Authority” means the National Drug Authority established by section 3;“duly qualified”, used in relation to a medical practitioner, dentist or veterinary surgeon, means a person recognised by law to practise medicine, surgery, dentistry and midwifery or, as the case may be, veterinary surgery;“generic name” means the International Non-proprietary Name (INN) established by a body of the World Health Organisation;“Indian hemp” includes the dried flowering or fruiting tops of the pistillate plant known as cannabis sativa or cannabis indica from which the resin has not been extracted, by whatever name the tops are called, and resins obtained from those tops, all preparations of which those resins form the base and all extracts or tinctures obtained from those tops;“inspecting officer” means a person empowered under Part VI of this Act to enter any premises;“international control” means the international conventions on the control of narcotic drugs and psychotropic substances;“International Non-proprietary Name (INN)” means the official name of a drug, regardless of the manufacturer;“licensed person” means a person licensed under section 14;“licensed seller” means a person licensed under section 15;“manufacture” includes any treatment of a plant, mineral or other substance for the purpose of extracting a drug;“Minister” means the Minister responsible for health;“narcotic drug” means a Class A drug or preparation;“pharmacist” means a pharmacist under the Pharmacy and Drugs Act;“prepared opium” means opium prepared for smoking and includes dross and any other residues remaining after opium has been smoked, and also includes any opium, for whatever purpose prepared, which is capable of being smoked;“proprietary drug” means a drug distributed for sale by retail under a brand name or other proprietary description and in a form ready for use;“register” means the register of specialties maintained under the Drug Authority;“restricted drug” means a classified drug or any other drug which is not an exempted drug;“substance” includes a preparation;“supply”, with its grammatical variations and cognate expressions, includes, in relation to a drug, the administration of any such drug.

Part II – National Drug Policy and national drug Authority

2. National Drug Policy

(1)The National Drug Policy shall be—

(a)to ensure that essential, safe, efficacious and cost-effective drugs are made available to the entire population of Uganda to provide satisfactory health care;

(b)to make a continuous review of the needs, knowledge and resources of essential drugs;

(c)to promote the rational use of drugs both in the public and private sector;

(d)to improve Government regulation and control on manufacture, production, importation, exportation, marketing and use of drugs;

(e)to provide systematic public information and professional training and retraining of health workers;

(f)to improve the registration of drugs and licensing of pharmaceutical premises;

(g)to intensify research in all types of drugs, including traditional medicines;

(h)to comply with the international regulations on drugs, including the conventions on narcotic drugs and psychotropic substances under international control; and

(i)to fight against drug and substance abuse.

(2)The National Drug Policy shall relate to the regulation of the importation, production, distribution, marketing, exportation and use of pharmaceuticals in the public as well as in the private sector and to any matter related to the above.

3. Establishment of National Drug Authority

(1)There is established an authority known as the National Drug Authority which shall be a body corporate with perpetual succession and a common seal and may sue or be sued in its corporate name.

(2)The Drug Authority shall consist of the Chairperson and the following persons—

(a)the Director of Medical Services;

(b)the Commissioner for Veterinary Services;

(c)the Commissioner for Trade;

(d)the director of the criminal investigation department;

(e)the chief of medical services, Ministry of Defence;

(f)the chief of pharmaceuticals and health supplies;

(g)the head of the Natural Chemotherapeutics Laboratory;

(h)the director of Mulago National Referral Hospital;

(i)a representative of each of the following—

(i)the National Medical Stores;

(ii)the Uganda Medical Association;

(iii)the Pharmaceutical Society of Uganda;

(iv)the Uganda Veterinary Association;

(v)the head of the School of Pharmacy, Makerere University;

(vi)the Uganda herbalists;

(vii)the Uganda Dental Association; and

(viii)the Joint Medical Stores;

(j)the Director General of the Uganda AIDS Commission; and

(k)two persons appointed from the public.

(3)The Chairperson and the members appointed under subsection (2)(k) shall be appointed by the Minister.

(4)The members appointed under subsection (3) shall be in office for three years and shall be eligible for re-appointment.

4. Application of seal

(1)The common seal of the Drug Authority shall be as the Drug Authority may determine and shall be kept by the Secretary.

(2)The common seal shall, when affixed into any document, be authenticated by any two signatures of the Chairperson, the Secretary and any other member of the Commission as may be authorised by the Drug Authority.

(3)A contract or instrument which if entered into or executed by a person not being a body corporate would not be required to be under seal may be entered into or executed without seal on behalf of the Drug Authority by the Secretary or any other person authorised by the Drug Authority.

(4)Every document purporting to be—

(a)an instrument issued by the Drug Authority and sealed with the common seal of the Drug Authority and authenticated in the manner prescribed in subsection (2); or

(b)a contract or instrument entered into or executed by the Drug Authority,

shall be received in evidence without further proof as that instrument duly issued or a contract duly entered into or executed unless the contrary is proved.

5. Functions of Drug Authority

The Drug Authority shall be charged with the implementation of the National Drug Policy and, in particular, but without derogation of the foregoing, shall—

(a)deal with the development and regulation of the pharmacies and drugs in the country;

(b)approve the national list of essential drugs and supervise the revisions of the list in a manner provided by the Minister;

(c)estimate drug needs to ensure that the needs are met as economically as possible;

(d)control the importation, exportation and sale of pharmaceuticals;

(e)control the quality of drugs;

(f)promote and control local production of essential drugs;

(g)encourage research and development of herbal medicines;

(h)promote rational use of drugs through appropriate professional training;

(i)establish and revise professional guidelines and disseminate information to health professionals and the public;

(j)provide advice and guidance to the Minister and bodies concerned with drugs on the implementation of the National Drug Policy; and

(k)perform any other function that is connected with the above or that may be accorded to it by law.

6. Commission and other bodies of Drug Authority

(1)There shall be a National Drug Authority Commission which shall consist of the Chairperson and four other members appointed by the Drug Authority from among themselves.

(2)The Chairperson of the Drug Authority shall be the Chairperson of the Commission.

(3)The functions of the Commission shall be—

(a)to exercise the functions of the Drug Authority which may require exercising when the Drug Authority is not sitting;

(b)to monitor and supervise the implementation of the decisions of the Drug Authority;

(c)to establish and revise the working procedure of the Drug Authority; and

(d)to perform any other function relating to the functions of the Drug Authority as the Authority may direct.

(4)There shall be the following committees of the Drug Authority—

(a)the committee on essential drugs; and

(b)the committee on the national formulary.

(5)The membership of the committee on essential drugs shall be as follows—

(a)a Chairperson appointed by the Drug Authority;

(b)the Commissioner of Curative Services of the Ministry of Health;

(c)the Chief of Pharmaceuticals and Health Supplies;

(d)the Chief of Medical Services, Ministry of Defence;

(e)the Head of the School of Pharmacy;

(f)a representative of each of the following specialities—

(i)physician;

(ii)paediatrician;

(iii)gynaecologist/obstetrician;

(iv)surgeon;

(v)psychiatrist;

(g)a member from the Private Medical Practitioners Association; and

(h)a non-government organisation pharmacist from the Joint Medical Stores.

(6)The committee on essential drugs shall have power to co-opt members deemed necessary.

(7)The membership of the committee on the national formulary shall be as follows—

(a)a chairperson appointed by the Drug Authority on the recommendation of the appropriate professional bodies;

(b)a member of the faculty of medicine of the universities in Uganda;

(c)a member of the faculty of veterinary sciences;

(d)a member from the school of pharmacy;

(e)a member from the Pharmaceutical Society of Uganda;

(f)a member from the Private Medical Practitioners Association;

(g)a member from the Uganda Medical Association;

(h)the Executive Director of the Uganda National Bureau of Standards; and

(i)a representative of each of the following specialities—

(i)physician;

(ii)surgeon;

(iii)paediatrician;

(iv)gynaecologist/obstetrician;

(v)psychiatrist.

7. Meetings of Drug Authority

(1)The Drug Authority shall meet for the discharge of its functions at least six times a year.

(2)The National Drug Authority Commission shall establish the working procedure for the Drug Authority.

Part III – Control of drug supply

8. National list of essential drugs

(1)There shall be a national list of essential drugs which shall be revised from time to time.

(2)There shall be a national formulary made of the national list of essential drugs and such other drugs as the Authority may approve.

(3)A person shall not import or sell any drug unless it appears on the national formulary.

(4)Notwithstanding subsection (3), a drug not appearing on the national formulary may be imported and sold after authorisation by the Drug Authority to meet emergency or extraordinary circumstances.

9. Selection of drug items

The Drug Authority shall receive from the committee on essential drugs the proposals of the revised list which shall be made in accordance with the available resources and existing diagnostic and therapeutic capacity.

10. Estimation of drug needs

(1)The Commission shall ensure regular assessment and estimation of the national drug needs both in the public and private sectors.

(2)Estimates of the national drug needs shall be expressed both in unit (quantity) and financial cost.

(3)For the purposes of providing accurate estimates of drug needs, the Commission shall promote and encourage investigations, including studies of current morbidity patterns, drug utilisation and available diagnostic and therapeutic resources.

11. Drug nomenclature

All drugs imported in Uganda shall be labelled, known and prescribed by their International Non-proprietary Names (generic names) except where no such name has been allocated and no satisfactory non-proprietary alternative exists.

12. Restricted drugs

(1)For the purpose of this Act and subject to this section—

(a)the drugs specified in Schedules 2, 3 and 4 to this Act shall be classified drugs;

(b)the drugs and articles specified in Schedule 5 to this Act shall be exempted drugs and articles; and

(c)any classified drug or any other drug which is not exempted shall be deemed to be a restricted drug.

(2)Subject to subsection (3), where a preparation contains any quantity of a drug which is included in Schedule 2, 3 or 4 to this Act, the preparation shall be deemed to be a classified or restricted drug of the same Class as the drug which it contains.

(3)Where an entry in Schedule 2, 3 or 4 to this Act defines the proportions of a drug which bring a preparation containing it within the list of restricted drugs, subsection (2) shall not apply to that preparation.

(4)Where, apart from this subsection, a preparation would fall to be treated as a Class A drug and also as a Class B or Class C drug or both, it shall be treated as a Class A drug only.

(5)Where, apart from this subsection, a preparation would fall to be treated as a drug of both Class B and Class C, it shall be treated as a Class B drug only.

13. Supply and dispensing of restricted drugs

(1)Subject to this section, no person shall mix, compound, prepare, supply or dispense any restricted drug unless that person is a registered pharmacist, medical practitioner, dentist or veterinary surgeon or a licensed person.

(2)Subsection (1) shall not prevent—

(a)the supply of any drug, other than a drug of Class A or B, by a licensed seller;

(b)the mixing, compounding or preparing of a drug under the immediate supervision of a registered pharmacist;

(c)the supply or dispensing of a restricted drug by a member of the staff of a hospital, dispensary or similar institution which has been authorised to do so by a general or special order of the Drug Authority; and

(d)the supply of restricted drugs subject to regulations made by the Minister after consultation with the Drug Authority, by a representative of a person engaged in the sale and supply of pharmaceutical goods for the purposes of giving free samples of the drugs to persons who may lawfully possess restricted drugs.

(3)A person registered or enrolled under the Nurses and Midwives Act or any other authorised person may supply or dispense restricted drugs in accordance with regulations made by the Minister in that behalf.

(4)The supply or dispensing of restricted drugs under subsections (2) and (3) shall be subject to the following—

(a)the restricted drug shall be distinctly labelled with the name and address of the person by whom it is supplied or dispensed;

(b)the following particulars shall, within twenty-four hours after the restricted drug has been supplied or dispensed, be entered in a book used regularly for the purpose, which shall be known as the Prescription Book—

(i)the date on which the restricted drug was supplied or dispensed;

(ii)the ingredients and quantity supplied;

(iii)the name and address of the person to whom the restricted drug was supplied;

(iv)the name and address of the person by whom the prescription was given,

except that paragraph (a) shall not apply in any case where any restricted drug is administered by a medical practitioner, dentist, veterinary surgeon or midwife, or under his or her direct supervision and in his or her presence.

(5)Any record kept under this section shall be open to inspection by an inspector of drugs.

14. Licensed persons

(1)If, on application made in the prescribed form by any person, the Drug Authority is satisfied—

(a)that the applicant is fit to carry on a business of mixing, compounding and preparing and supplying restricted drugs by retail;

(b)that the business, so far as concerns the restricted drugs, will be carried on under the immediate supervision of a pharmacist in each set of premises where the business is to be carried on;

(c)in the case of a body corporate, that at least one of the directors is a pharmacist resident in Uganda; and

(d)in the case of a partnership, that at least one of the partners is a pharmacist resident in Uganda,

the Drug Authority may, on payment of a prescribed fee, issue a licence to the applicant to carry on the business required at the premises and on conditions specified in the licence.

(2)A licence issued under this section shall be valid for a period specified in the licence, but the Drug Authority may revoke the licence if, at any time, it is satisfied that the licensed person has contravened any provision of this Act or any condition specified in the licence, or has ceased to be fit to carry on the business.

(3)Any person who carries on the business of a pharmacist without a licence issued under this section commits an offence and is liable, on conviction, to a fine not exceeding fifty currency points or to imprisonment for a term not exceeding five years, or both.

15. Licensed sellers

(1)If, on application made in the prescribed form by a person other than a pharmacist or a licensed person, the Drug Authority is satisfied—

(a)that the applicant is fit to carry on a business of supplying by retail restricted drugs, other than drugs of Class A or B;

(b)that the area in which the applicant proposes to carry on that business is not sufficiently served by existing facilities for the retail supply of the drugs; and

(c)that the applicant is an authorised person,

the Drug Authority may issue to the applicant a licence authorising him or her, subject to any conditions specified in the licence, to carry on the business required from the premises specified in the licence.

(2)A licence issued under this section shall be valid for a period specified in the licence, but the Drug Authority may revoke the licence if, at any time, it is satisfied that the holder of the licence has contravened any provision of this Act or any condition specified in the licence, or has ceased to be fit to carry on the business.

16. Places from which restricted drugs may be supplied

(1)No person shall carry on the business of supplying restricted drugs from any premises—

(a)if restricted drugs including drugs of Class A or B are supplied, unless either a general or a limited certificate is issued under this Act for the purpose;

(b)if restricted drugs not including drugs of Class A or B are supplied, unless either a general or a limited certificate issued under this Act is in force.

(2)No person shall supply any drug by means of an automatic machine.

17. Certificate of suitability of premises

(1)If on application made in the prescribed form for a certificate in relation to any premises, the Drug Authority is satisfied that the accommodation, fixtures, equipment and other physical attributes of those premises render those premises suitable for the supply of restricted drugs or for the supply of restricted drugs excluding drugs of Classes A and B, it may issue in respect of those premises either a general or limited certificate.

(2)Every person carrying on the business of supplying restricted drugs from the premises in respect of which a certificate issued under this section is in force shall notify the Drug Authority of any alteration in the physical attributes of the premises, or if no alteration occurs in any calendar year, shall notify the Drug Authority of that fact before the end of January in the following year.

(3)A certificate issued under this section shall remain in force until a date specified in the certificate, but the Drug Authority may revoke the certificate if, at any time, it is satisfied, on the recommendation of the inspector of drugs, that, owing to an alteration or deterioration in the physical attributes of the premises, the premises have ceased to be suitable for the supply of the restricted drugs, or of restricted drugs other than drugs of Classes A and B, as the case may be.

(4)The Drug Authority shall keep a register in the prescribed form of the premises in respect of which a certificate is issued under this section.

18. Loss of Class A or B drugs

(1)Any person entitled under this Act to supply or dispense a Class A or B drug shall, upon the loss of that drug in his or her possession or control or of any records kept under this Act in relation to that drug, report that loss to the inspector of drugs, within seven days of the loss, giving particulars of the ingredients and quantities of the drug or the particulars of the records lost.

(2)Any person who contravenes any provision of this section commits an offence and is liable, on conviction, to a fine not exceeding fifty currency points or to imprisonment for a term not exceeding five years, or both.

Part IV – Special provisions relating to classified drugs

19. Classified drugs

The Minister may, by statutory instrument, on the advice of the Drug Authority, declare a drug to be a classified drug.

20. Need for prescription for classified drugs

(1)A pharmacist or licensed person shall not supply a Class A or Class B Group I drug unless it is under prescription reasonably believed by the person supplying the drug to be valid.

(2)A prescription shall be valid only if—

(a)it is in indelible writing, dated and signed with the usual signature of a registered medical practitioner, dentist or veterinary surgeon;

(b)it states the name, qualification and address of the person signing it;

(c)it states the name and address of the person for whose treatment it is given or, if signed by a veterinary surgeon, of the person in charge of the animal to which the drug is to be administered;

(d)it is signed by a dentist, and bears the words “for dental treatment only” or, if signed by a veterinary surgeon, and bears the words “for animal treatment only”;

(e)it indicates the total amount of the drug to be supplied and the dose to be taken or the manner of its application or use; and

(f)it has not previously been fully dispensed.

(3)A prescription shall be fully dispensed if the drug prescribed has been supplied once, unless it clearly states—

(a)the number of times it may be dispensed; and

(b)the intervals at which it may be dispensed, and shall in that case, be fully dispensed if the drug prescribed has been supplied the stated number of times.

(4)This section shall not apply—

(a)if the drug is supplied, whether personally or on a signed order, to a medical practitioner, dentist, veterinary surgeon, pharmacist or licensed pharmacy for the purpose of being subsequently dispensed or supplied or used for purposes of scientific education or research; or

(b)if the drug is supplied from the dispensing department of an approved institution in accordance with regulations made by the Minister in that behalf.

21. Action to be taken in relation to prescription

Where a classified drug is supplied under a prescription—

(a)the person supplying the drug shall enter on the prescription in indelible writing the date on which it is supplied and the name and address of the supplier;

(b)if the prescription is fully dispensed, it shall be retained by the supplier and, for two years thereafter, shall be kept on the premises at which it was dispensed in such a manner as to be readily available for inspection.

22. Classified drugs to be supplied to responsible persons

A pharmacist or licensed pharmacy shall not supply a Class A or B drug to a person who is not reasonably believed by the supplier to be a person to whom the drug may properly be supplied.

23. Supply to conform to prescription

No person shall supply any classified drug which does not conform to the prescription or order under which it is supplied.

24. Classified Drugs Book

(1)Every person who supplies Class A, B or C Group II drugs shall keep in all premises from which the drugs are supplied by him or her a book of the prescribed description to be known as the Classified Drugs Book.

(2)Subject to subsection (3), before any person supplies Class A, B or C Group II drugs, he or she shall enter or cause to be entered in the Classified Drugs Book the following particulars—

(a)the name and quantity of the drug to be supplied;

(b)the name and address of the person who requires the drug;

(c)the purpose for which the drug is stated to be required;

(d)the signature of the person to whom the drug is delivered; and

(e)the date of the delivery.

(3)Where any classified drug is sold in the presence of an agent or servant of the person by whom it is to be used or where sale is effected by post, the following provisions shall apply—

(a)before the sale is completed, the seller shall obtain an order in writing, signed by the purchaser showing—

(i)the purchaser’s name, address and occupation;

(ii)the name and the quantity of drug to be purchased; and

(iii)the purpose for which it is required,

but where a person represents that he or she urgently requires a classified drug for the purpose of his or her trade, business or profession, and satisfies the seller that, by reason of some emergency, he or she is unable before delivery to furnish the order in writing, the seller may deliver the drug to the purchaser who shall, within twenty-four hours of the sale, furnish the seller with a written order;

(b)before the sale is completed, the seller shall satisfy himself or herself that the signature on the order is that of the person by whom it is supposed to be signed and that that person carries on the occupation stated in that order, being an occupation for which the drug is properly required;

(c)the requirements of subsection (2) as to the making of entries in the Classified Drugs Book shall be complied with except that in place of the signature of the person to whom the drug is delivered, it shall be sufficient to record “signed order” giving a reference by which the particular signed order may be readily identified;

(d)all signed orders and prescribed records of transactions to which this subsection applies shall be retained on the premises where the sales were made for two years.

(4)Any person who contravenes any of the provisions of this section commits an offence and is liable, on conviction, to a fine not exceeding one hundred currency points or to imprisonment for a term not exceeding five years, or both.

25. Containers and labels

No person shall supply any classified or restricted drug unless—

(a)the drug is in a container of the prescribed description; and

(b)the container bears a label giving the prescribed particulars of its contents.

26. Further restrictions on the supply of narcotics

(1)The Minister may, by statutory instrument, make regulations further restricting the persons who may supply narcotic drugs, and otherwise controlling the supply of those drugs.

(2)No person shall supply any narcotic drugs under international control other than for medical, dental or veterinary purposes.

27. Possession of classified drugs

(1)The following persons may be in possession of classified drugs, but to the extent only and subject to the limitations prescribed below—

(a)any person specified in section 14 for the purposes of that section;

(b)a licensed person or seller of classified drugs, on premises registered under this Act;

(c)a wholesale dealer licensed under this Act for the purposes of the licence and on the premises so licensed;

(d)any person, institution or department to whom a classified drug has been lawfully sold in accordance with this Act, for the purpose for which the sale was made;

(e)any person for whom the classified drug has been lawfully supplied or dispensed by a duly qualified medical practitioner, dentist or veterinary surgeon or by an approved institution.

(2)Any person who is in possession of a classified drug otherwise than in accordance with this section commits an offence and is liable, on conviction, to a fine not exceeding one hundred currency points or to imprisonment for a term not exceeding five years, or both.

28. Withdrawal of authority

(1)Where any person authorised to obtain or supply narcotics under this Act is convicted of any offence under this Act, if the Minister is of the opinion that that person ought not to be allowed to obtain, possess or supply drugs, he or she may, acting in accordance with the recommendation of the Drug Authority, by notice in the Gazette, withdraw the authority of that person.

(2)Where the person whose authority is withdrawn under subsection (1) is a registered or licensed medical practitioner or dentist or a duly qualified veterinary surgeon, the Minister may, by notice in the Gazette, direct that it shall not be lawful for that person to give prescriptions or orders for the purposes of this Act.

29. Drug addicts

(1)Every medical practitioner or dentist shall keep a record in the prescribed form of all persons who are addicted to any drug specified in Schedule 2 or 3 to this Act and shall at least every year make a report to the Minister specifying the names of those persons and the drugs to which they are addicted.

(2)Notwithstanding any other provision of this Act, no person may prescribe or supply any drug specified in Schedule 2 or 3 to this Act for the use of a person whom he or she knows or has reason to believe is addicted to any such drug, unless he or she is authorised in writing to do so by the Minister and in a manner and subject to conditions that may be prescribed.

Drugs generally

30. Impure drugs not to be supplied

Any person who—

(a)sells any drug, medical appliance or similar article which is not of the nature, substance and quality demanded or which, unless otherwise agreed at the time of demand, does not conform to the standards laid down in the authorised pharmacopoeia; or

(b)supplies any drug which is unwholesome or adulterated or which does not conform to the prescription under which it is supplied, commits an offence and is liable, on conviction, to a fine not exceeding two hundred fifty currency points or to imprisonment for a term not exceeding ten years, or both.

31. Power to call for information as to proprietary drugs

(1)Where the Drug Authority has reason to believe that any person is proposing to sell any proprietary drug by retail or to procure, whether directly or indirectly, its sale by retail, the Drug Authority may require that person to furnish to it—

(a)details of the composition of the drug;

(b)copies of any descriptive matter published or proposed to be published in relation to the drug; and

(c)any other information that the Drug Authority may require.

(2)No disclosure of information furnished under this section shall be made without the consent of the person by whom it was furnished.

32. Power to prohibit retail sale of proprietary drugs

The Drug Authority may prohibit the sale by retail of a proprietary drug if, in the opinion of the Drug Authority—

(a)claims are made for the drug, whether or not in a statement furnished under section 31, which are unjustified;

(b)the use of the drug may endanger the health of the user or there may be other undesirable effects in the use of the drug;

(c)details of the composition of the drug furnished under section 31 differ substantially from those disclosed on an analysis of samples of the drug obtained from retail suppliers; or

(d)descriptive matter published in relation to the drug differs substantially from that, whether or not in the same language, contained in copies furnished to the Drug Authority in relation to the drug under section 31.

33. Control of publication of descriptive matter

(1)Subject to this section, no person shall, by way of advertisement, publish, in whatever manner, in relation to any drug, descriptive matter calculated to lead to the use of that drug—

(a)for prevention or treatment of any disease specified in Schedule 6 to this Act;

(b)for the purpose of termination or influencing the course of human pregnancy; or

(c)for any purpose relating to enhancing human potency.

(2)Subject to this section, the Drug Authority may, with the approval of the Minister, serve on any person a notice prohibiting him or her from publishing in relation to any drug descriptive matter referred to in the notice.

(3)This section shall not apply to the publication of descriptive matter—

(a)by direction of the Minister;

(b)in a document intended for persons whose profession or employment calls for a knowledge either of drugs generally or of drugs of the description to which the matter in question relates; or

(c)for the purposes of an application for the grant of a patent.

34. Return of details of pharmacy business

(1)Every person carrying on a pharmacy business on any premises shall, within twenty-one days after the commencement by him or her of that business on those premises and annually in the month of January thereafter, send to the Drug Authority returns in the prescribed manner, stating—

(a)the location and postal address of the premises;

(b)the name and principal postal address of the person carrying on the business; and

(c)the name of the pharmacist supervising the sale of drugs at those premises.

(2)If any alteration occurs in the particulars stated in the last return made, the person carrying on the business shall, within twenty-one days of the alteration, send notice in writing to the Drug Authority.

35. Drug regulation and registration of specialities

(1)The Drug Authority—

(a)may scientifically examine any drug for the purposes of ascertaining efficacy, safety and quality of that drug;

(b)shall institute a system for the approval of drugs or drug combinations not included in the national list of essential drugs.

(2)The Drug Authority shall keep a register of specialities in the prescribed form.

(3)If, on application made in the prescribed manner and on payment of the prescribed fee, the Drug Authority is satisfied—

(a)that the drug or preparation in respect of which the application is made has not previously been registered; and

(b)that the use of the drug or preparation is likely to prove beneficial, the Drug Authority shall register the name and description of that drug or preparation.

(4)Where, on application so made, the Drug Authority is not satisfied as aforesaid, it shall notify the applicant that the application is dismissed on the grounds which shall be specified.

(5)The Drug Authority may direct at any time for the deletion of any drug or preparation from the register.

(6)The register shall, at all reasonable times, be open for public inspection on payment of such fee as may be prescribed.

36. Drug quality

(1)The Drug Authority shall advise the Minister on measures to be taken to ensure the quality of drugs imported into or held in stock in the country.

(2)The execution of the measures prescribed shall be entrusted to bodies charged with the importation and distribution of drugs.

(3)The inspection of drugs and measures prescribed may be delegated to the chief of pharmaceuticals and health supplies or any other person properly qualified in pharmaceuticals and health supplies.

Wholesale trade

37. Licence required for wholesale supply of restricted drugs

(1)No person shall carry on a business of supplying restricted drugs by wholesale unless he or she is authorised to carry on that business by a licence granted under this section.

(2)The Drug Authority may, on application made in the prescribed form and upon payment of the prescribed fee, grant a licence for the carrying out of a business of supplying restricted drugs by wholesale, if the Drug Authority is satisfied—

(a)that the applicant is a person to whom the licence can properly be granted;

(b)that the business will be carried on in separate premises apart from any other business;

(c)that the business will be carried on in premises under the immediate supervision of a pharmacist;

(d)in the case of a company, that at least one of the directors is a pharmacist resident in Uganda; and

(e)in the case of a partnership, that at least one of the partners is a pharmacist resident in Uganda.

(3)A licence granted under this section may include a condition prohibiting or limiting the supply of restricted drugs of a description specified in the condition, and shall be deemed to include a condition prohibiting the supply of any prepared opium or Indian hemp which is prepared for smoking.

(4)A licence granted under this section shall be valid for a period specified in the licence; but the Drug Authority may revoke the licence if, at any time, it is satisfied that the holder of the licence has contravened any provision of this Act or any condition contained in the licence or has ceased to be fit to carry on the business.

Control of manufacture and storage of drugs

38. Restrictions on manufacture of classified drugs

(1)No person shall manufacture any drug or preparation which is not included on the national formulary unless the drug or preparation is approved by the Drug Authority.

(2)No person shall, unless approved by the Drug Authority in that behalf, manufacture a speciality.

(3)No person shall manufacture any classified drug unless the processes of manufacture are carried out or supervised by a pharmacist.

(4)Subsection (3) shall not apply to the manufacture of preparations mentioned in Schedule 7 to this Act if the processes of manufacture are carried out or supervised by a medical practitioner.

39. Further restrictions on manufacture of drugs

(1)The Minister may, by statutory instrument, make regulations further limiting the persons who may manufacture any drug or preparation and the premises in which they may be manufactured, and otherwise controlling their manufacture.

(2)No person shall manufacture any narcotic drug or psychotropic substances under international control for purposes other than for medical, dental or veterinary use.

40. Clinical trials

(1)The Drug Authority may issue a certificate to any person for the purpose of carrying out clinical trials in respect of a drug that may be specified in the certificate.

(2)No person may carry out any clinical trial in respect of any drug unless that person is in possession of a certificate issued under subsection (1).

41. Local research and production

(1)The Drug Authority shall encourage research by persons carrying on research and development in herbal and other medicines and where appropriate take such medicines into production as a component of the drug supply.

(2)Where the Drug Authority considers it economically advantageous and it is in the interest of the development of a national drug industry, it shall encourage and develop national production of essential drugs.

42. Storage

(1)Where restricted or classified drugs are kept on any premises, they shall be kept in accordance with Schedule 8 to this Act, but that Schedule shall not apply to drugs supplied to an individual for the treatment of himself or herself or another individual residing with him or her or an animal in his or her possession or control.

(2)If an act is done on any premises in contravention of the above subsection then—

(a)in a case where the act constitutes a breach of a duty imposed by or under the terms of his or her employment upon a person employed on the premises, that person shall be deemed to have committed an offence;

(b)in any other case, the occupier of the premises shall be deemed to have committed an offence.

(3)Nothing contained in subsection (2) shall prevent any person who wilfully removes or alters the label on any container, or does any other act, as opposed to an omission, in respect of a restricted drug, from being treated as having committed an offence under subsection (1).

Part V – Control of transport, import and export of drugs

43. Transportation of drugs

(1)The consignment and transportation of classified drugs shall be in accordance with Schedule 9 to this Act.

(2)Notwithstanding subsection (1), the Minister may, on the advice of the Drug Authority, make regulations for the control of the transportation of any drug or class of drugs.

44. Importation of pharmaceuticals

(1)No person or body shall import any drugs into Uganda without a licence in relation to their import from the Drug Authority.

(2)The licence shall be valid for one year and shall state the range of preparations to be imported during that period.

45. Exportation of drugs

(1)No person or body shall export any drug or preparation without a licence in relation to that export from the Drug Authority.

(2)The licence shall be valid for one year and shall specify the drug to be exported.

(3)A person who exports any classified drugs shall keep a record in the prescribed form of all exports.

46. Import and export licences

(1)The Drug Authority may grant a permit for the import or the export of a classified drug if—

(a)an application for the permit is made in the prescribed form and the applicant pays the prescribed fee; and

(b)the Drug Authority is satisfied that the applicant is a person to whom the permit can properly be granted.

(2)No permit shall be granted for the import or export of any narcotic drugs or psychotropic substances under international control, other than for medical, dental or veterinary use.

(3)A permit granted under this section may be granted generally for the import or export of classified drugs or limited to specified drugs.

Part VI – Powers of entry and investigation

47. Powers of entry

(1)An inspector or assistant inspector of drugs may enter—

(a)at all reasonable times, any premises in respect of which a certificate issued under this Act is in force or on which any person is required to carry out any functions imposed under this Act;

(b)at any time, any premises on or in relation to which he or she has reasonable cause to suspect that an offence under this Act has been or is being committed;

(c)at any reasonable time, any premises on which a business relating to the manufacture or supply of narcotic drugs is carried on;

(d)at any time, any vehicle or vessel which he or she reasonably suspects is being or is about to be used in the commission of an offence under this Act.

(2)Any police officer not below the rank of assistant superintendent may enter, at any reasonable time, any premises or detain and enter any vehicle or vessel on or in relation to which he or she has reasonable cause to suspect that an offence under this Act has been or is being committed.

48. Powers of investigation

(1)A drug inspector, assistant inspector of drugs or police officer of the rank of assistant superintendent empowered under this Act to enter any premises, vehicle or any other means of transport may—

(a)inspect the premises, vehicle or vessel and any articles found in the premises, vehicle or vessel;

(b)require any person on or in the premises, vehicle or vessel to furnish any information in his or her possession as to the activities carried on or in the premises and the person by whom they are carried on or the purposes for which the vehicle or vessel is being used;

(c)take away any drug or records and other documents found on or in the premises, vehicle or vessel.

(2)Where a drug is taken away pursuant to this section, reasonable payment thereof shall be tendered by the inspecting officer, but—

(a)no payment need be tendered in respect of a drug if the inspecting officer reasonably suspects that the drug is unfit for its purpose by reason of deterioration, impurity, adulteration or other defect; but if the drug is later found on analysis not to be so unfit, reasonable payment shall be tendered by the inspecting officer in respect of the drug which is not returned to its owner in good condition;

(b)no payment shall be made in respect of a drug if the inspecting officer anticipates that proceedings for an offence under this Act will be brought in respect of the drug; but if the proceedings are not commenced within six months, reasonable payment shall be tendered by the inspecting officer in respect of the drug which is not returned to its owner in good condition.

49. Authority to be shown

An inspecting officer exercising any powers conferred by this Act shall produce, on demand, a duly authenticated document showing that he or she is entitled to exercise those powers.

50. Obstruction

No person shall obstruct an inspecting officer exercising powers under this Part or fail to comply with a requirement made by him or her in exercise of those powers.

Part VII – Secretariat and financial provisions

51. Secretariat

(1)The Drug Authority shall have a Secretariat which shall be responsible for the day-to-day operations of the Drug Authority.

(2)The Secretariat shall be headed by the Secretary to the Drug Authority who shall be appointed by the Drug Authority on terms and conditions that the Drug Authority may determine.

(3)In addition to any other functions that may be conferred upon him or her by the Drug Authority, the Secretary shall—

(a)have custody of the seal of the Drug Authority;

(b)be responsible for taking the minutes of the Drug Authority and the Commission and for keeping the records of the transactions of the Drug Authority.

(4)There shall be other officers and employees of the Drug Authority the Drug Authority may determine.

(5)An employee of the Drug Authority shall not, in his or her personal capacity, be liable to any civil or criminal proceedings in respect of any act done or omission made in good faith in the performance of his or her duties under this Act.

52. Funds of Drug Authority

(1)The funds of the Drug Authority shall consist of—

(a)grants from the Government;

(b)grants and loans from any body, organisation or person;

(c)interest on savings made by the Drug Authority;

(d)money that may accrue to the Drug Authority in the discharge of its functions; and

(e)money from any other source as may be approved by the Minister.

(2)The Drug Authority shall possess a bank account in a bank approved by it.

53. Estimates

(1)The Drug Authority shall, within three months before the commencement of each financial year, prepare and submit to the Minister, estimates and expenditure for the Drug Authority for the next ensuing year; and any time before the end of a financial year, the Drug Authority may prepare and submit to the Minister for approval any estimates supplementary to the estimates of a current year.

(2)The Minister shall notify the Drug Authority of his or her decision on the estimates submitted to him or her within one month of the submission of the estimates.

(3)No expenditure shall be made out of the funds of the Drug Authority unless that expenditure is part of the expenditure approved by the Minister under the estimates for the financial year in which the expenditure is to be incurred or in supplementary estimates for that year.

54. Accounts

(1)The Drug Authority shall keep proper books of accounts of all its income and expenditure and proper records in relation to those accounts.

(2)Subject to any direction given by the Minister responsible for finance, the Drug Authority shall cause to be prepared in respect of each financial year, a statement of account which shall include—

(a)a balance sheet, a statement of income and expenditure and a statement of surplus and deficit; and

(b)any other information in respect of the financial affairs of the Drug Authority as the Minister responsible for finance may require.

55. Audits

(1)The accounts of the Drug Authority shall, in respect of each financial year, be audited by the Auditor General or an auditor appointed by him or her.

(2)The Drug Authority shall ensure that within four months after the end of the financial year a statement of account is submitted to the Auditor General for auditing.

(3)The Auditor General and any auditor appointed by him or her shall have access to all books of accounts, vouchers and other financial records of the Drug Authority and be entitled to have any information and explanation required by him or her in relation to those records.

(4)The Auditor General shall, within two months after receipt of statements of accounts under this section, audit the accounts and deliver to the Drug Authority and the Minister a copy of the audited accounts and his pr her report on those accounts.

Part VIII – Miscellaneous

56. Rational use of drugs

(1)The Drug Authority shall, in the interest of public health and the economical use of resources, and in consultation with the bodies concerned, promote the rational use of drugs both in the private and public sector.

(2)In the implementation of subsection (1), the Drug Authority may adopt methods and materials which have proved effective in other countries and shall, among other methods, do the following—

(a)develop basic and postgraduate training in the health sector;

(b)promote public awareness and knowledge of the proper use of drugs; and

(c)disseminate information on the purposes and progress of the National Drug Policy.

57. Offences and penalties

(1)A person contravening a provision of this Act commits an offence and, where no punishment is provided, is liable—

(a)to a fine not exceeding fifty currency points;

(b)to a withdrawal of the licence or permit for a period not exceeding five years;

(c)to cause the items in contravention to be impounded, forfeited, destroyed or disposed of in a manner prescribed by the Minister;

(d)to imprisonment not exceeding one year; or

(e)to any two of the above punishments, and for any subsequent offence under this Act, a person is liable to a fine not exceeding one hundred currency points or to a term of imprisonment not exceeding five years, or both.

(2)Any person who commits an offence under this Act and no other punishment is provided is liable—

(a)where the offence relates to Class A drugs, to a fine not exceeding one hundred currency points or to imprisonment for a term not exceeding five years, or both;

(b)where the offence relates to narcotic drugs or psychotropic substances under international control and is a second or more subsequent offence, to a term of life imprisonment;

(c)where the offence relates to manufacturing, smoking or having possession of any narcotic drug or psychotropic substance under international control and is a second or more subsequent offence, to a term not exceeding ten years.

(3)Where no case is proved in respect of any drug or article taken from an accused person, the court shall order reasonable payment to the owner in respect of the drug or article which is not returned to him or her in good condition.

(4)No proceedings shall be instituted for an offence under section 35 without the consent of the Director of Public Prosecutions.

58. Vicarious criminal responsibility

(1)Any act or omission which if done by an individual would be an offence under this Act or any regulations made under it shall, if done by a body corporate, be deemed to be an offence committed by every director, secretary and manager of the body corporate, unless the director, secretary or manager proves that the offence was committed without his or her consent or connivance and that he or she exercised all such diligence to prevent the commission of the offence as he or she ought to have exercised, having regard to the nature of his or her functions in that capacity and to all the circumstances of the case.

(2)If an offence under this Act or any regulations made under it is committed by a partner in a firm, every person who at the time of the commission of the offence was a partner in that firm, or was purporting to act in that office, shall be deemed to have committed the like offence unless he or she proves that the offence was committed without his or her consent or connivance and that he or she exercised all such diligence to prevent the commission of the offence as he or she ought to have exercised, having regard to the nature of his or her functions in that capacity and to all the circumstances of the case.

59. Evidence

(1)In any proceedings under this Act—

(a)any licence, permit or certificate purporting to have been issued under this Act; or

(b)any document purporting to state the results of an analysis carried out on behalf of the Drug Authority for the purposes of this Act, shall be prima facie evidence of the facts stated in it.

(2)Where, in any proceedings under this Act, a person is charged with—

(a)the unlawful possession, sale or supply of any restricted drug and the drug is in a container; or

(b)any other offence where the contents of a container are in issue in the proceedings,

and the container appears to the court to be intact and in its original state of packing by its manufacturer, the contents of the container shall be deemed, unless the contrary is proved, to be of the description specified on the label of the container.

60. Drugs Bureau

(1)There shall be established a Drugs Bureau under the Office of the Inspector of Drugs.

(2)The Drugs Bureau shall—

(a)keep and maintain a register in which shall be entered details of the composition of all drugs registered under section 35;

(b)keep and maintain a list of all toxic substances, their composition, toxicity and antidotes;

(c)supply such information to medical practitioners, dentists or veterinary surgeons in respect of drugs as may be in its possession in emergency cases of poisoning.

(3)In order to discharge its functions under this section, the Drugs Bureau may require any person to give any information in his or her possession or control regarding any drug, and that person shall furnish the information within such period as may be specified by the Drugs Bureau.

(4)Subject to subsection (2)(c), any information furnished to the Drugs Bureau under subsection (3) shall be kept confidential and shall not be published without the consent of the person furnishing the information.

61. Regulations

The Minister may, by statutory instrument, on the advice of the Drug Authority, make regulations generally for better carrying into effect the provisions of this Act—

(a)including the period within which all drugs imported—

(i)should be labelled and prescribed by their International Non-proprietary Names (INN) or generic names; and

(ii)but not appearing on the national list of essential drugs or the national formulary may be off the market;

(b)prescribing the procedure to be followed at meetings, inquiries and other proceedings of the Drug Authority and its committees;

(c)prescribing conditions to be inserted in licences or permits granted under this Act, and otherwise prescribing things to be done in relation to such licences or permits;

(d)laying down conditions in respect of supplies and issues of drugs by hospitals and the storage of drugs by hospitals and the records to be kept;

(e)use of drugs in first-aid boxes notwithstanding any other enactment;

(f)prohibiting, regulating or restricting the manufacture, sale or advertising of drugs, pharmaceutical preparations and therapeutic substances;

(g)regulating, restricting or prohibiting the importation, sale or advertising of surgical instruments and appliances;

(h)regulating and restricting the use of classified drugs for agricultural, horticultural, mining and industrial purposes, andthe measures to be taken to protect the persons using such classified drugs, including the types and standards of protective clothing which shall be worn;

(i)requiring the registration and treatment of persons addicted to drugs;

(j)the registration and operation of authorised persons; and

(k)prescribing anything which under this Act may be prescribed.

62. Power to amend Schedules

(1)The Minister responsible for finance may, by statutory instrument, with the approval of Cabinet, amend Schedule 1 to this Act.

(2)The Minister may, after consulting the Drug Authority, by statutory order, amend Schedules 2, 3, 4, 5, 6, 7, 8 and 9 to this Act.

Schedule 1 (Sections 1, 62(1))

Currency point

A currency point is equivalent to twenty thousand shillings.

Schedule 2 (Sections 12, 29, 62(2))

Class A drugs or narcotics

The drugs included in this class may only be imported, or exported, manufactured or used, under authority. They may be sold by retail only on the prescription of a duly qualified medical practitioner, dentist, and veterinary surgeon but only for medical, dental or veterinary purposes and may be supplied only by a licensed person.3-Methylfentanyl3-MethylthiofentanylAcetorphineAcetyl-Alpha-MethylfentanylAcetyldihydrocodeine, except as specified in group II of class BAcetylmethadolAlfentanilAlphacetylmethadolAlphameprodineAlphamethadolAlpha-MethylfentanylAlpha-MethylthiofentanylAlphaprodineAnileridineBenzylmorphineBetacetylmethadolBeta-Hydroxy-3-MethylfentanylBeta-HydroxyfentanylBetameprodineBetamethadoletaprodineBezitramideBuprenorphineCannabis (the flowering and fruiting tops ofthe Cannabis plant)Cannabis Resin, Extracts and Tinctures of CannabisCarfentanilCocaineCodeine, except as specified in group II of class BCodoximeConcentrate of Poppy StrawCyprenorphine hydrochlorideDesomorphineDextromoramideDextropropoxypheneDiampromideDiethylthiambuteneDifenoxinDihydrocodeine, except as specified in group II of class BDihydroetorphine VDimenoxadolDimepheptanolDimethylthiambuteneDioxaphetyl ButyrateDiphenoxinDiphenoxylateDipipanoneDiprenorphineDrotebanolEcgonineEmbutramide VEthylmethylthiambuteneEthylmorphineEtorphine VFentanyl and its saltsFurethidineDiamorphine (Heroin)HydrocodoneHydromorphinolHydromorphoneHydroxypethidineIsomethadoneKetobemidoneLevomethorphanLevomoramideLevophenacylmorphanLevorphanolMeperidine and its intermediatesMetazocineMethadone, its salts, intermediates and derivativesMethyldesorphineMethyldihydromorphineMetoponMorpheridineMorphineMorphine MethobromideMorphine-N-OxideMyrophineNicocodineNicodicodineNicomorphineNoracymethado1Norcodeine, except as specified in class B, group IINorlevorphanolNormethadoneNormorphineOpium (all preparations made direct from opium are considered to be opium)OxycodoneOxymorphonePara-FluorofentanylPepap (l-phenethyl-4-phenyl-4-piperidinol acetate (ester))Pethidine, its salts, intermediates and derivativesPhenadoxonePhenazocinePhenomorphanPhenoperidinePholcodine, except as specified in class B group II or in class CPiritramidePropiramRacemethorphanRacemoramideRacemorphanRemifentanilSufentanilTapendatolThebaconThebaineThiofentanylTilidineTrimeperidineAll substances referred to in this Schedule include, unless expressly excluded or unless listed in another Schedule, the following—

(a)the isomers of such substances, where the existence of such isomers is possible within the specific chemical designation;

(b)the esters and ethers of such substances and of the isomers referred to in paragraph (a), as well as the isomers of such esters and ethers, where the existence of such esters, ethers and isomers is possible;

(c)the salts of such substances and of the isomers referred to in paragraph (a), as well as the salts of the esters, ethers and isomers referred to in paragraph (b), where the existence of such salts is possible;

(d)the isomers of any of the salts referred to in paragraph (c), where the existence of such isomers is possible; and

(e)all preparations and mixtures of any of the above.

Schedule 3 (Sections 12, 29, 60(2))

Class B drugs or controlled drugs

Group I

The following drugs may be supplied by retail, by a licensed person only on the prescription of a duly qualified medical practitioner, dentist or veterinary surgeon, but only for medical, dental or animal treatment respectively.4-Aminosalicylic acid (p-aminosalicylic acid) and its salts5-Fluorouracil its salts derivatives and metabolites5-Aminosalicylic acid (Mesalazine or Mesalamine)5-Phenylhydantoin; its alkyl and aryl derivatives; their salts6-Mercaptopurine and its derivatives, except if listed in another schedule Abamectin VAbciximabAcamprosate, and its salts carbose, and its saltsAcebutolol, and its saltsAceclofenacAcepromazine, and its salts VAcetahexamideAcetanilide; alkyl acetanilides (except as provided in Group II ofthis class)Acetazolamide and its saltsAcetylcarbromalAcocanthera, glycosides ofAdenium, glycosides ofAlcuronium chlorideAllylisopropyl-acetylureaAmidopyrine, its salts; amidopyrine sulphonates, their saltsAcetylcholine, when intended for ophthalmic useAcetylcysteine except as specified in group II ofthis classAcetylpromazine maleate VAcetylsalicylic acid except as specified in group II ofthis class and class CAcipimoxAcitrelin, its salts and derivativesAconiazide, and its saltsAcyclovir, and its salts, except when intended for topical applicationAdalimumabAdapalene, its salts and derivativesAdefovir, its salts and derivativesAdenosine and its salts (for parenteral use)Agalsidase alfaAgalsidase betaAgomelatineAklomide VAlbendazole injection VAlbuminAlefaceptAlemtuzumabAlendronic acid, and its saltsAlfacalcidolAlfadolone VAlfaprostol VAlfuzosin, and its saltsAliskiren, and its saltsAllobarbitalAllopurinolAllylisopropyl-acetylureaAlmotriptan and its saltsAlpha-chloralose VAlphadolone and its saltsAlpha-galactosidaseAlphaxaloneAlteplase, its salts and derivativesAltrenogest VAltretamineAlverine, and its salts (for parenteral use)Amantadine, and its saltsAmbenonium chlorideAmbrisentanAmfepramoneAmfetamineAmicarbalide VAmidaprilAmifostine, and its saltsAmikacin, its salts and derivativesAmiloride, and its saltsAmino acids, in preparations intended for parenteral useAminocaproic acidAminoglutethimideAminometradineAminophyllineAminopromazine (proquamezine) and its saltsAminopterin, and its saltsAminopyrine and its derivatives VAmiodarone and its saltsAmisulprideAmitriptyline, and its saltsAmlexanox, its salts and derivativesAmlodipine, and its saltsAmmonium bromideAmmonium chloride, in preparations intended for parenteral useAmmonium molybdate VAmmonium tetrathiomolybdate VAmodiaquine, except as specified in group II ofthis classmonolevulinic acid, its salts and derivativesUnoxapineAmphomycin, and its salts, its esters and salts ofsuch estersAmphotericin, its salts and derivativesAmprolium, its salts and derivativesAmsacrine, and its saltsAmyl nitriteAnagrelide, and its saltsAnakinra, its salts and derivativesAnastrazoleAndrogenic, oestrogenic and progestational substances and their derivatives, with either hormonal, prohormonal or anti-hormonal activitY (except as specified elsewhere in the schedules) such as:BenzoestralBicalutamideClomiphene and its altsDesogestrelDienogestDrospirenoneDydrogesteroneEstradiolEstramustineEstrogenEstroneEthinylestradiolEthynodiolEtonogestrelFlugestoneFlutamideHydroxyprogesterone hexanoateLevonorgestrelMegestrolMesteroloneMethyltestosteroneMifepristoneNorelgestrominNorethandroloneNorethindroneNorethisteroneNorgestimateNorgestrelProgesteroneProligestone VStanozololStilbenes such as Diethylstibesterol (Stilbesrol)TamoxifenTestosteroneToremifeneUlipristal acetateAnetholeAnthrax vaccineApomorphineApramycin, and its saltsAprepitant and its derivativesAprotininArecoline, and its saltsArgatroban, its salts and derivativesAripiprazoleArsenic and its compounds, including Arsenic trioxide, except as specified in class CArteether (beta-alfa)ArtemisininArtemether injectionArterolane, and its saltsArtesunate, except as specified in group II of this class and in class CAsiaticosideAsparaginaseAstemizole, and its saltsAtenolol, and its saltsAtipamezole, and its salts VAtomoxetine, and its saltsAtorvastatin, and its saltsAtovaquone and its salts, except as specified in group II of this classAtracurium, and its saltsAtropine, and its salts, preparations intended for parenteral useAuranofinAurothioglucoseAvian coccidiosis vaccine VAvian Infectious bronchitis vaccine VAvilamycin VAzacyclonol acid, and its saltsAzaperone injection VAzaribineAzatadine, and its saltsAzathioprine, and its saltsAzelaic acidAzithromycin, its salts and derivativesAzlocillin, its salts and dervativesAztreonam, its salts and derivativesBacaplerminBacillus Calmette—Guerin (BCG) vaccine VBacitracin, its salts and derivatives except as specified in group II of this classBaclofen and its saltsBarbituric acid, its salts; derivatives of barbituric acid; their salts; compounds of barbituric acid; their salts; their derivatives, such as:AmobarbitalAprobarbitalButabarbitalButalbitalCyclobarbitalMethohexitalMethylphenobarbital (Mephobarbital)PentobarbitalPhenobarbitalPrimidoneSecbutabarbitalSecobarbitalThiamylal (Surital)ThiopentalVinylbitalBalsalazideBambermycin VBambuterol, and its saltsBaquiloprim VBarium sulphateBasiliximabBeclomethasone, except as specified in group II of this classBedaquilineBemegrideBemiprarinBenactyzine, and its saltsBenazepril, and its saltsBendazac and its saltsBendrofluazide (Bendroflumethiazide)Benoxaprofen, and its saltsBenserazide, and its saltsBenzafibrateBenzfetamineBenzhexol (Trihexyphenidyl) and its saltsBenzocaine and its salts; except as specified in group II of this class and in class CBenzodiazepines, and salts or derivatives thereof (except as listed elsewhere in the schedules), such as:AlprazolamBromazepamBrotizolamCamazepamChlordiazepoxideClobazamClonazepamClorazepateClotiazepamCloxazolamDelorazepamDiazepamEstazolamEthyl loflazepateFludiazepamFlunitrazepamFlurazepamHalazepamHaloxazolamKetazolamLoprazolamLorazepamLormetazepamMedazepamMidazolamNimetazepamNitrazepamNordazepamOxazepamOxazolamOxcarbazepinePhenazepamPinazepamPrazepamTemazepamTetrazepamTriazolamZolazepamBenzoyl Peroxide except as specified in group II of this classBenzthiazideBenztropine, its homologues; their saltsBeractantBetahexol and its derivativesBetahistine, and its saltsBetaxololBethanecholBevacizumabBicozamycinBicyclomycinBimatoprostBisoprololBismuth and its salts, except as specified in group II of this class and in class C BivalirudinBleomycinBlood, its components and products derived from bloodBoldenone undecylenateBonsetan, its salts and derivativesBordetella bronchiseptica (Infectious tracheobronchitis) vaccine VBoric acid in preparations intended for parentral useBovine ephemeral fever vaccine VBovine mastitis vaccine VBovine Tuberculin vaccine VBretylium, BrinzolamideBrolamfetamineBromocriptine, and its saltsBrucellosis vaccineBumetanideBunamidineBuparvaquone, for parenteral use VBupivacaine, and its salts (for parenteral use)BuquinolateBuserelin injectionBuspirone, and its saltsBusulphan, and its saltsButamisoleVButenafine hydrochlorideCabergoline and its salts.Caffeine, except as specified in group II of this class or in class CCalcitoninCalcitriolCalcium acetateCalcium borogluconate VCalcium disodium edetateCalcium dobesilateCalcium gluconate in injectable form for parenteral use.Cambendazole VCandesartan, its salts and derivatives Canine coronavirus vaccineVCanine distemper virus vaccine VCanine parvovirus vaccine VCapecitabineCapreomycin and its salts, deravatives, its esters and salts of such estersCaptodiamine and its saltsCaptopril and its saltsCaramiphen; its saltsCarbachol, its ophthalmic preparations when intended for glaucomaCarbadox, VCarbamazepineCarbetocinCarbidopa, and its saltsCarbimazoleCarbomycin VCarbop latinCarboplostCarbromalCarisoprodalCarnitineCarprofen, its salts and derivatives VCarvedilol, and its saltsCathineCathinoneC-C chemokine receptor type 5 (CCR5) antagonists such as maraviroc CeliprololCephalosporins, their derivatives and salts (except as specified in group II of this class), such as:CefacetrileCefaclorCefadroxilCefalexinCefaloniumCefaloridineCefalotinCefamandoleCefapyrinCefazolinCefepimeCefiximeCefodizimeCefoperazoneCefotaximeCefpiromeCefpodoxime proxetil.Cefprozil, its salts and derivativesCefquinomeCefradineCeftazidimeCeftiofurCeftriaxoneCefuroximeCephaloridineCephalosporin CCerebrolysinCetrorelixChlamydophiliosis vaccineVChloral hydrateChlorambucil, its salts and derivativesChloramphenicol, its salts and derivatives except as specified in class CChlordiazepoxide and its saltsChlormethiazoleChloroprocaineChloroquine and its salts, except as specified in group II of this classChlorpheniramine, and its salts, in preparations intended for injectionChlorphenoxmine, and its saltsChlorphentermine; and its saltsChlorothiazide and other derivatives of Benzol 2:4-thiadiazine -7-sulphonamide 1:1-dioxide, whether hydrogenated or notChlorpromazine, and its saltsChlorpropamide, and its saltsChlorprothixene, and other derivatives of 9-methylenethiazane-ther, their saltsChlorthalidone, and other derivatives of o-chlorobenzene sulphonamideCholera vaccineCholine theophy 11 inateCidofovirCilastatin and its saltsCimetidine, and its saltsCinchocaine except as specified in group II of this classCiprofibrateCisapride and its salts Cisatracurium and its salts CisplatinCitalopram and its saltsClarithromycinClavulanic acid, except as specified in group II of this class Clazuril VClemizole penicillinClenbuterol and its salts VClindamycin, its salts and derivatives.Clofazimine Clofibrate Clomethiazole Clomipramine and its salts Clonidine and its salts. Clopidogrel and its salts Cloprostenol, its salts and derivatives, V Clorexolone, its salts Clorsulon V Closantel and its salts V Clostridial infections vaccineV Clostridium botulinum toxins type A & B Clozapine, and its salts Cobicistat Colchicine Colecalciferol Colesevelam Colestipol ColestyramineColistin (Polymyxin E), its salts and derivatives ConivaptanContagious Caprine Pleuropneumonia vaccine VCopper salts, when intended for injection for parenteral nutrition, V Corticosteroids; their salts and derivatives; whether natural or synthetic, (except as specified elsewhere in the schedules); such as:BetamethasoneBudesonideCiclesonideClobetasolClobetasoneCortisolCortisoneDesonideDesoximetasoneDesoxycorticosterone PivalateVDexamethasoneDiflucortoloneDifluprednateFludrocortisone acetate,FludroxycortideFlumethasoneFlunisolideFluocinoloneFluticasoneHydrocortisoneMethylprednisoloneMometasonePrednicarbatePrednisolonePrednisoneTriamcinoloneCoumarin and its derivatives, such as:4-HydroxycoumarolAcenocoumarolDicoumarolEsculoside (Esculin)WarfarinCromoglycic acid and its salts; except as specified in group II of this classCrofelemerCuprimyxinCyclandelateCyclizine, except as specified in group II of this classCyclopenthiazideCyclopentolate and its salts in preparations for parenteral useCyclophosphamideCycloserine and its saltsCyclosporin ACycrimine, and its saltsCytarabine and its salts,Cythioate VDabigatran, its salts and derivativesDacarbazineDaclatasvirDaclizumabDactinomycinDalteparin and its salts.Danaparoid, its salts and derivativesDanazolDantrolene and its saltsDapagliflozinDapiprazole and its saltsDapoxetine, and its saltsDaptomycinDarifenacinDaunorubicin and its salts.Debrisoquine and its saltsDecamethoxinDecoquinateVDeferasiroxDeferoxamine and its salts.DelavirdineDemacarium bromideDesferrioxamine mesilateDesfluraneDesimipramine and its saltsDesipramine; its saltsDeslorelinVDespramine, and its saltsDetomidine and its salts VDexamfetamineDextranDextrose in solutions for parenteral useDiacerinDiaminazene and its salts VDimenhydrinate and its salts except as specified in group II of this classDiatrizoateDiaveridine VDiazoxide and its saltsDichloracetic acidDichlorophen VDichlorvos V in preparations intended for oral useDiclazuril VDiclofenac, and its salts; except as specified in group II of this classDictyocaulus viviparus vaccineDicycloverine (Dicyclomine) except as specified in group II of this class.Diethylcarbamazine and its saltsDiflunisal and its saltsDigitalis, its glycosides, derivatives and their saltsDihydrochlorothiazideDihydrostreptomycin, its salts and derivativesDiidohydroxyquinDiiodohydroxyquinoline (lodoquinol)Diloxanide furoateDiltiazem and its salts,DimercaprolDimethicone and its salts, except as specified in group II of this classDimethindeneDimethyl SulfoxideDimethylglycineDimetridazole injection VDiminazene and its salts VDinitolmide, V except as specified in class CDinoprostDinoprostoneDiphenidol and its saltsDiprophyllineDipyridamoleDirithromycinDisodium hydrogen citrateDisopyramide and its saltsDisulfiramDithiazanine iodide VDiuredosanVDivalproexDobutamine and its saltsDocetaxel and its saltsDomperidoneDonepezilDopamineDopexamineDoramectin, VDomase alpha (rhDNase)Dorzolamide and its saltsDosulepinDoxapramDoxazosin and its saltsDoxepin and its saltsDoxercalciferol and its derivativesDoxorubicin (Adriamycin) and its saltsDronabinolDronedaroneDroperidol and its saltsDrotaverineDuloxetine and its saltsDutasterideDyflos (Isoflurophate)East Coast Fever vaccineVEchinocandins, their salts and derivatives, such as Caspofungin,Anidulafungin and MicafunginEconazole and its saltsEcothiophate and its salts VEctylurea and its saltsEculizumabEdrophoniumEfalizumabEfavirenzEflomithine, its salts and derivativesElectrolyte solutions for parenteral useEletriptan and its saltsEmedastine and its saltsEmeproniumEmtricitabineEmylcamateEnalapril, its salts and derivativesEnfluraneEnfuvirtideEnilconazole except when intended for application to the skinEnoxaparin and its saltsEnoximoneEnramycin VEntacaponeEntecavirEnteric red mouth disease vaccine VEphedrine and its salts, except as specified in group II of this classEpinephrine (adrenaline) and its saltsEpirubicinesc and its saltsEplerenoneEpoprostenol and its saltsEprinomectin VEprosartan, its salts and derivativesEpsiprantel VEptifibatide and its saltsEquine anti-human thymocyte globulinEquine chorionic gonadotrophin, VEquine gamma globulin;Equine herpesvirus vaccine VEquine influenza virus vaccine VErdosteineErgot, alkaloids of, whether hydrogenated or not; their homologues; any salt of any substance falling within this item (except as provided in Group II of this class) such as Ergotamine, Ergometrine, Cabergoline, NicergolineErlotinib and its saltsErtapenem and its saltsErythrityl tetranitrateErythropoietinEscitalopram and its saltsEsmolol and its saltsEsomeprazole and its salts, except as specified in group II of this classEtamiphylline, its salts and derivativesEtamsylateEtanerceptEthacrycin acid, its saltsEthambutol, and its salts.EthchlorvynolEthinamateEthionamide, and its saltsEthoheptazine, and its saltsEthopropazine hydrochloride (profenamine), and its saltsEthosuximideEthotoin and its saltsEtilamfetamineEtilefrineEtiproston VEtodolac, its salts and derivativesEtomidateEtoposide and its derivativesEtoricoxibEtravirineEtymemazine and its saltsEverolimusExemestaneEzetimibeFamciclovir and its salts.Famotidine, except as specified in group II of this classFampridineFebantel VFebuxostatFeline Chlamydial vaccine VFeline leukaemia vaccine VFeline panleucopenia vaccine VFeline viral respiratory disease complex vaccine VFeline viral rhinotracheitis vaccine VFelodipine and its saltsFencamfaminFenetyllineFenfluramine and its saltsFenofibrateFenoprofen, except as specified in group II of this classFenoterolFenproporexFenticonzoleFertirelin VFexofenadine and its saltsFilgrastimFinasterideFipronil V, when used in preparations intended for cutaneous sprayFlavoxateFlecainide and its saltsFlorfenicol and its derivativesFluanisone FlubendazoleFluconazole, except as specified in group II of this class FlucytosineFludarabine, its salts and derivatives Flufenamic acid FlumazenilFlumequin VFlunarizine and its saltsFlunixin, its salts and derivatives VFluorescein, except when intended for ophthalmic use by the topical route onlyFluoxetine and its saltsFlupentixol, its salts and derivatives.Fluphenazine and its salts.FluprostenolFlurbiprofen, except as specified in group II of this classFluvastatin, its salts and derivativesFluvoxamine and its saltsFolinate (Folinic acid)Fondaparinux sodiumFormoterol, and its saltsFortimycin VFosaprepitantFoscamet sodiumFosfomycin and its saltsFosphenytoin and its saltsFowl pox vaccine VFramycetin and its saltsFuradantin Furaltadone and its salts VFurazolidone and its saltsFurazolium chlorideFurosemideFusidic acid and its salts, its esters and salts or such estersFusion inhibitors and their salts such as enfurvitideGabapentin, its salts and derivativesGadopentetic acidGalantamine, its salts and derivativesGallamine; its salts, derivatives and quaternary compoundsGallium and its saltsGamithromycin VGamma-aminobutyric acid, its derivatives and salts there ofGanciclovir and its salts and derivativesGemcitabine and its salts and derivativesGemfibrozil and its saltsGemifloxacin, its salts and derivativesGemtuzumabGentamycin and its salts, its esters and salts of such estersGlafenineGleptoferronGlibenclamideGliclazideGlimepirideGlipizideGlucosamine, substances, preparations and mixtures when intended for the treatment of primary and secondary osteoarthritis, osteochondrosis and spondylosisGlutethimide, and its salts.Glyburide, and its salts and derivatives.Glyceryl trinitrate (Nitroglycerin)Glycopyrrolate and its saltsGlycopyrronium and its saltsGoat pox virus vaccine VGoserelin and its saltsGramicidin, except as specified in group II of this classGranisetron and its saltsGrepafloxacin, its salts and derivativesGuanabenzGuanethidine, and its saltsHalofantrine and its saltsHalofenateHalofuginone VHaloperidol and its saltsHalothaneHaloxon VHeparin and its saltsHepatitis A vaccineHepatitis B immunoglobulinHeptaminolHexapropymateHexoprenalineHistrelin and its saltsHomatropine and its salts, except as specified in group II of this classHomidium bromide (ethidium bromide) VHuman anti-D immunoglobulinHuman anti-thymocyte rabbit immunoglobulinHuman menopausal gonadotrophin (Menotrophin)Human normal immunoglobulinsHyaluronic acid and its salts, except as specified in group II of this class and class CHyaluronidaseHydralazine and its saltsHydrochlorothiazideHydroflumethiazideHydroxycarbamide (Hydroxyurea)Hydroxychloroquin and its saltsHydroxyethyl starch, and its derivates intended for parentral useHydroxyzine, and its saltsHyoscine and its salts, except as provided in group II of this classHyoscyamine, except as provided in class CIbalizumabIbandronic acid and its saltsIbuprofen, except as specified in group II of this class and in class CIdarubicin and its saltsIdoxuridine, except when intended for application to the skinIfosfamideIloprostImidacloprid VImidocarb, and its salts VImipenem, its salts and derivativesImipramine, and its saltsIndacaterolIndapamide, and its saltsIndomethacin, and its salts, except as specified in group II of this classIndoraminInfectious Bovine Rhinotracheitis (IBR) vaccines VInfectious bursal disease (Gumboro) vaccine VInfectious canine hepatitis vaccine VInfectious Coryza vaccine VInfectious tracheobronchitis vaccine VInfliximabInosine pranobexInositolInsulinIntegrase inihibitors, and their salts such as;BictegravirDolutegravirElvitegravirRaltegravirInterferons, such as Interferon-alpha, Interferon-beta, Interferon-gamma, Interferon-omega and their corresponding subtypes.Intra uterine devices; whether hormonal or copper based lohexol lopanoic acid lopromide lopamidolIpratropium, and its saltsIprindole, and its saltssoniazid, and its salts, derivatives and their saltsbesartaninotecan and its saltssetharine, and its saltsIsocarboxazid and its salts Isoconazole and its salts,IsofluraneIsometamidium and its salts VIsoprenalineIsopropamide and its saltsIsopyrinIsosorbide, its salts and derivativesIsotretinoin, its salts and derivativesIsoxsuprine and its saltsIsradipine and its saltsItraconazole and its saltsIvabradineIvermectinJosamycinKanamycin and its saltsLincomycins, their salts, their esters and salts of such estersKetamine and its saltsKetoconazole and its salts, except as specified in group II of this class and class CKetoprofen and its salts, except as specified in group II of this classKetorolac and its saltsKetotifen and its saltsKitasamycinLabetalol and its saltsLacidipineLacosamideLadepasvirLamotrigine and its saltsLanatosideLanreotide and its saltsLansoprazole except as specified in group II of this classLasalocid VLatanoprostLaudexium, its saltsLedipasvirLefetamineLeflunomideLepirudinLeptospirosis vaccine VLercanidipineLetrozoleLeuprolideLevamfetamineLevamisole and its salts, for injection VLevetiracetamLevocabastine, except as specified in group II of this classLevodopa and its saltsLevomepromazineLevosalbutamol, except as specified in group II of this class lidocaine, except as specified in group II of this class and class CLincomycin, and its salts and derivativesLinezolid and its saltsLisinopril, and its saltsLithium, and its salts except as specified in group II of this classLodoxamideLofepramineLomoxicam (Chlortenoxicam)Losartan and its saltsLovastatinLoxapine, and its saltsLumefantrine except as specified in class CLumiracoxibLungworm disease vaccine VLuprostol VLutropin alfaMacrogol (polyethylene glycol), when used for faecal impaction, or for the purposes of bowel cleansing prior to surgery or diagnostic procedures, except when intended for the treatment of constipation.Maduramycin VMafenideMagnesium glutamate hydrobromideMalathion VMandelic acidMannitolMarmomustine, and its saltsMebezonium, and its salts VMebutamateMeclofenokate, and its saltsMarek’s disease vaccine VMaropitant VMazindolMebezonium and its salts VMebutamateMeclofenamic acid, and its saltsMeclofenokate, and its saltsMecloqualoneMedetomidine injection VMedical gases, such as:CarbondioxideMedical airNitrogenNitrous oxideOxygenMefenamic acid, its salts and derivatives, except as specified in group II of this class.MefenorexMefloquine, its salts and derivatives; in oral preparations intended for treatment of malaria infectionMelarsomine VMelarsoprolMelatonin, except as specified as specified in group II of this classMeloxicam, its salts and derivatives except as specified in group II of this class.Melphalan and its derivativesMemantineMeningococcal vaccineMepacrineMepenzolate bromideMephenesin, and its derivativesMepirizoleMepivacaine and its salts, in preparations intended for parenteral useMeprobamateMeropenem, its salts and derivativesMesnaMesocarbMetamfetamine RacemateMetaproterenol (Orciprenaline) when intended for the prevention or delay of labour and its preparations for injection, or when contained in respirator solutionsMetaraminol, and its saltsMetaxalone, and its saltsMetchlorothiazideMetformin, its salts and derivativesMethacholineMethaqualone, and its saltsMethenamine (Hexamine)MethimazoleMethisazoneMethixene; and its saltsMethocarbamo 1Methohexital and its saltsMethotrexate, and its saltsMethoxyfluraneMethoxysalenMethsuximideMethy sulphonyl methaneMethyldopa and its saltsMethylene blue (Methylthioninium chloride), when used for treatment of methemoglobinemiaMethyloneMethylpentynol; its esters and other derivativesMethy Ipheni dateMethyprylonMetoclopramide and its saltsMetolazone and its saltsMetomidate and its saltsMetronidazole except as specified in group II of this classMetoprolol and its saltsMianserinMibefradil.Miconazole, and its salts except as specified in group II of this class.Milbemycin and its derivatives VMiloxacin VMilrinone and its saltsMineral salts either alone or in combination,(a)in preparations intended for parenteral use(b)except as listed elsewhere in the schedules; when intended for correction of pH of body fluids or correction of electrolyte imbalances; except as specified in group II of this class and class C.Minoxidil, except as specified in group II of this classMirosamycin VMirtazapine and its saltsMisoprostolMitomycin and its saltsMitopodozide, its saltsMoclobemideModafinilMonensin V except as specified in class CMontelukast and its saltsMoracizineMorantel VMoxidectin VMoxonidineMupirocin, except as specified in group II of this classMustine and any other N-substituted derivatives of di-(2-chloroethyl) amine; their saltsMycophenolate mofetil, its derivatives and salts there ofNabiloneNabumetoneNadololNadroparinNaftidrofuryl oxalateNalorphineNalorphine, and its saltsNaloxone and its saltsNaltrexoneNandrolone decanoateNaphthalene-1-yl (1-Pentyl-1h-Indol-3-yl) MethanoneNaproxen, and its salts, except as specified in group II of this class.Narasin VNaratriptanNatalizumabNatamycinNateglinide, its salts and derivatives.N-BenzylpiperazineNebivolol and its saltsNedocromilNeomycin and its salts; except as specified in group II of this classNeostigmine and its saltsNepafenacNetilmicinNetobimin VNiacin (Nicotinic acid) when intended for hypercholesterolaemiaNicarbazin VNicardipineNiclosamideNicorandilNicotine, except as specified in group II of this class.NifedipineNiflumic acidNifuroxazideNifurtimoxNilotinib and its saltsNimesulideNimodipineNimorazoleNimotuzumabNitarsoneNitazoxanideNitrofurazone (Nitrofural)Nitroscanate VNitroxynil and its salts VNizatidineNon-Nucleoside Reverse Transcriptase Inihibitors, and their salts such as;DelavirdineDoravirineEfavirenzEtravineNevirapineRilpirivineNorepinephrine (Noradrenaline)Nortryptyline; and its saltsNoscapineNosiheptideNovobiocin and its saltsNucleoside and Nucleotide Reverse Transcriptase Inihibitors, and their salts such as;AbacavirDidanosineEmtricitabineLamivudineStavudineTenofovirZalcitabineZidovudineObidoximeOctreotide and its saltsOlanzapineOlaquindox VOleandomycin and its salts; its esters and their saltsOlmesartan, and its saltsOlsalazineOmalizumabOmeprazole and its salts, except as specified in group II of this class.Ondansetron and its saltsOrf (Contagious ecthyma) vaccine VOrlistat, except as specified in group II of this classOrmetoprim, and its salts VOmidazoleOrphenadrineOxaliplatinOxantel VOxaprozin, its salts and derivatives.OxcarbazepineOxethazaine (oxetacaine) except as specified in group II of this classOxfendazole VOxibendazole VOxiconazoleOxolinic acid VOxprenololOxybuprocaine, and its saltsOxybutyninOxyclozanide VOxyphenbutazonePaclitaxel, and its derivativesPaliperidone, its salts and derivativesPalivisumabPalonosetronPancreatic enzymes such as amylase, lipase and proteasesPancuronium and its saltsPantoprazole and its saltsPantothenate injectionPapaverine, except as specified in group II of this classParacetamol, except as specified in group II of this class and class CParaldehydeParamethadioneParomomycin and its salts, its esters and salts of such estersPargyline; and its saltsParoxetine, and its saltsParvaquone VPemoline, and its saltsPenbutololPenciclovir and its salts, except as specified in group II of this class.PenicillaminePenicillin antibiotics, their salts and derivatives (except as specified elsewhere in the schedules), such as:AmoxicillinAmpicillinAzlocillinBenethamine penicillin VBenzathine penicillinBenzylpenicillinCarbenicillinCioxacillinDicloxacillinFlucloxacillinHetacillin VMecillinamMethicillinMezlocillinNafcillinOxacillinPenethamate (hydroiodide) VPenicllin GPhenethicillinPhenoxymethylpenicillinPiperacillinProcaine fortified penicillinTemocillinTicarcillinTobicillinPentamidine, and its saltsPentazocine, and its saltsPentoliniumPentoxifylline and its saltsPepsinPericyazine and its saltsPerindoprilPeritoneal and haemoldialysis preparationsPerphenazine and its saltsPestes des petits ruminants virus vaccine VPhenacemidePhenaglycodolPhenamidine VPhenazopyridine PhenbutrazatePhendimetrazinePhenelzine and its saltsPhenindionePhenmetrazinePhenoxybenzaminePhenterminePhentolamine and its saltsPhenylbutazone and its saltsPhenylephrine, except as specified in group II of this class and class CPhenylpropanolamine (norephedrine), except as specified in group II of this classPhenytoin, and its saltsPholedrinePhysostigmine, its salts and derivativesPilocarpinePimobendanPimozine.PindololPioglitazone and its saltsPiperacetazine and its saltsPiperazine and its saltsPiperonyl VPipotiazinePipradrolPiracetamPirbuterolPirlimycin and its salts VPiroxicam, its salts and derivatives except as specified in group II of this classPituitary gland, the active principles of, whether natural or synthetic, such as:Adrenocorticotrophic hormoneAnti-diuretic hormoneChorionic GonadotropinFollicle-stimulating hormoneFollitropin alfaGonadorelin (Gonadotropin Releasing Hormone)Growth hormoneLuteinising hormoneMelanocyte-stimulating hormoneOxytocinProlactinThyroid-stimulating hormonePoloxalene VPolygelinePolymyxin B, and its saltsPolysulfated glycosaminoglycan VPolythiazidePorcine parvovirus (PPV) Vaccine VPorcine pneumonia Vaccine VPotassium bromidePotassium IodidePralidoxime and its saltsPrasugrelPravastatin and its saltsPraziquantelPrazosin and its saltsPregabalin, its salts and derivativesPregnant Mare’s Serum Gonadotropin VPrimaquine and its saltsProbenecid and its saltsProcainamide and its saltsProcarbazine, and its saltsProcaterolProchlorperazineProcyclidine and its saltsProguanil and its salts, except as specified in group II of this classPromethazine, and its salts; except as specified in group II of this classPropafenone, and its saltsPropentofyllinePropionylpromazinePropofolPropranolol, and its saltsPropylhexedrine; its saltsProtamine sulfateProtease inihibitors, and their salts such as;AmprenavirAtazanavirDarunavirFosamprenavirIndinavirLopinavirNelfinavirPipranavirRitonavirSaquinavirProthionamideProthipendyl, and its saltsProxymetacaine, and its saltsPseudoephedrine, except as specified in group II of this class and class CPsilocybinePurines, their salts and derivatives, whether natural or synthetic (except as specified elsewhere in the schedules)Pyrantel, its salts and derivativesPyrazinamidePyridostigmine PyrimethaminePyrimidines, their salts and derivatives, whether natural or synthetic (except as specified elsewhere in the schedules)Pyronaridine and its saltsPyrovaleroneQuetiapine, its salts and derivativesQuinacrineQuinaprilQuinapyramine V, its salts derivativesQuinethazoneQuinidine and its saltsQuinine and its saltsQuinolones and fluoroquinoles, and their salts such as;CiprofloxacinDanofloxacin VDifloxacin VEnrofloxacin VEprofloxacin VFlumequine VFlumequine VGatifloxacinLevofloxacinLomefloxacinMorbofloxacin VMoxifloxacinNadifloxacinNaldixic acidNorfloxacinOfloxacinOrbifloxacin VPefloxacinPradofloxacin VSarafloxacin VSparfloxacinRabeprazole and its saltsRabies immunoglobulinRacecadotril (acetorphan)Radiopharmaceuticals, being radio compounds and radio-active labelled compounds, when used for diagnostic or therapeutic purposes, unless listed elsewhere in the schedulesRafoxanide VRaloxifene and its saltsRamipril, its salts and derivativesRanibizumabRanitidine, and its salts except as specified in group II of this classRanolazineRaubasine and its saltsRauwolfia alkaloids, salts and derivativesRemoxipride and its saltsRepaglinide, its salts and derivativesReproterolReserpineRibavirinRicobendazole VRifamycins, their salts, their esters and salts of such esters, including:RifabutinRifampicinRifapentineRifaximinRimiterolRisedronate sodiumRisperidone and its saltsRitodrine and its saltsRituximabRivaroxabanRizatriptanRobenacoxib VRobenidine VRocuronium and its saltsRoflumilastRomifidine, and its salts VRonidazole, its salts and derivatives VRopiniroleRose BengalRosiglitazone and its saltsRosuvastatin and its saltsRoxarsone VRoxatidineRoxithromycinRuxolitinibSalbutamol, except as specified in group II of this class and in class CSalinomycin VSalmeterol and its saltsSalmonellosis/Fowl Typhoid vaccine VSaxagliptinScorpion anti-venomSecnidazoleSedecamycin VSelamectin VSelegiline and its saltsSemduramicin VSertaconazole and its saltsSertindoleSertraline and its saltsSevelamer hydrochlorideSevofluraneSheep pox virus vaccine VSildenafil and its saltsSimethicone, except as specified in group II of this classSimvastatinSirolimusSitagliptinSitaxentan and its saltsSnake anti-venomSofosbuvirSodium chloride when formulated alone in preparations intended for parenteral or oral useSodium iodideSodium nitroprusside and its saltsSodium oxybateSodium stibogluconateSodium thiosulphateSodium valproateSofosbuvirSolifenacinSolutions for parentral nutrition (glucose, protein hydrolysates, aminoacids or lipid/fat emulsions)Solutions of carbohydrates or proteins, synthetic or natural substances used for injection as plasma volume expandersSorbitol, in preparations intended for parenteral administrationSotalol and its saltsSpectinomycin, its salts and derivativesSpiramycin and its saltsStreptomycin, its salts, its derivatives and their saltsFosfomycin (Sulphomycin), its derivatives and their saltsSpironolactonetreptogramins their salts, derivatives and their salts; including:alfopristinPristinamycinQuinupristinVirginiamycinStreptokinaseStreptozocinStrontium and its salts, when indicated for oral use for the treatment of osteoporosis in adultsStrychnine VStyramateSubstances commonly known as vaccines, sera, toxins, anti-toxins and antigens; if not listed anywhere in the schedulesSucralfateSulbactamSulconazole and its saltsSulfonamide antibiotics, their salts, derivaties and salts thereof; (except as specified elsewhere in the schedules) such as:Phthalylsulfathiazole VSuccinylsulfathiazoleSulfacetamideSulfachlorpyridazineSulfadiazineSulfadimerazin VSulfadimethoxineSulfadimidineSulfadoxineSulfafurazole VSulfaguanidineSulfamerazineSulfamerazine VSulfamethazineSulfamethazine VSulfamethoxazoleSulfamethoxineSulfamethoxypyridazineSulfamonomethoxineSulfanilamideSulfapyridineSulfaquinoxalineSulfasalazineSulfathiazoleSulfisoxazoleSulindac and its salts.Sulphinpyrazone and its saltsSulphones; their salts and derivatives such as DapsoneSulpirideSumatriptan and its saltsSuraminSuxamethonium and its saltsSylimarinSyrosingopine, and its saltsTacrolimus and its saltsTadalafil and its saltsTafluprostTamsulosin and its saltsTasonerminTaurolidineTazaroteneTazobactamTeflubenzuronTegaserod and its saltsTeicoplaninTelbivudineTelithromycin, its salts and derivatives and salts thereofTelmisartan, its salts and derivatives and salts thereofTemozolomideTemsirolimusTenecteplaseTeniposideTenocyclidinTenoxicam, and its saltsTerazosin and its saltsTerbinafine, except as specified in group II of this classTerbutaline, and its salts except as specified in group II of this classTerconazole and its saltsTerdecamycin V Terfenadine and its saltsTeriparatide and its salts.Tetanus immunoglobulinTetrabenazine, and its saltsTetracaine (Amethocaine), and its salts, except as specified in group II of this class and class CTetracyclines, their salts, derivatives and their salts, (except as listed anywhere else in the schedules), including:ChlortetracyclineDemeclocycline (Demethylchlortetracycline)DoxycyclineLymecyclineMethacyclineMinocyclineOxytetracycline RolitetracyclineTetracyclineTigecyclineTetramisole VThalidomide, and its saltsTheophylline, and its saltsThiabendazole VThiacetazone, its salts; its derivatives and salts thereofThiamphenicolThiocarlide, and its saltsThioctic acid (thioctacid)ThioguanineThiopropazate and its saltsThioproperazine and its saltsThyroid gland; its active principles, their salts and derivatives thereof;whether natural or synthetic, such as:Desiccated thyroidLevothyroxine sodiumLiothyronineThyroglobulinThyroid extractThyrotropinThyrotropin alfaThyroxinTri-iodothyronineTiamulin VTiaprofenic acid and its saltsTiboloneTildipirosin VTiletamineTilmicosinTimepidium, except as specified in group II of this classTimolol and its saltsTinidazoleTinzaparin and its saltsTioconazole, except as specified in group II of this classTiotropium bromideTirofiban, its salts and derivativesTizanidine and its saltsTobramycin, its salts and derivativesTolazamideTolazoline and its saltsTolbutamideTolfenamic acid, its salts and derivativesTolmetin and its saltTolperisone and its saltsToltrazuril VTolvaptanTopiramateTopotecanMeprobamateMercaptopurine, and its salts, derivatives of mercaptopurine, their salts Mescaline, and other derivatives of phenethylamine formed by substitution in the aromatic ring, their saltsTorasemide (torsemide) and its saltsTramadol hydrochlorideTrandolapril, its salts and derivativesTranexamic acidTrastuzumabTravoprostTrazodone and its saltsTretamine, and its saltsTretinoin, its salts and derivativesTriamterene, and its saltsTriaziquone; its saltsTricaine and its saltsTrichlormethiazideTriclabendazole VTrifluoperazine and its saltsTriflupromazine, and its saltsTrifluridineTrilostane VTrimeprazine (Alimemazine) its salts and derivatives VTrimethadione (Troxidone)TrimethoprimTrimipramine and its saltsTryptan blue solution for opthalamic useVasopressin, its analogues, whether natural or synthetic; such as Desmopressin and TerlipressinTuberculinTubocurarineTulathromycin VTulobuterolTybamateTylosin VTylvalosin VTyphoid vaccineTyrothricin, except as specified in group II of this class.Viomycin and its saltsUlinastatinUnoprostone, its salts and derivativesUracil, salts of, when sold for treatment of cancerUrokinaseUrsodeoxycholic acid and its saltsValacyclovir and its saltsValdecoxib and its saltsValganciclovir, its salts and derivativesValnemulin VValrubicin and its derivativesValsartan, its salts and derivativesVancomycin, its salts and derivativesVardenafil and its saltsVaricella immunoglobulinVaricella—zoster virus vaccineVasoactive intestinal polypeptideVecuroniumVedaprofen, its salts and derivativesVelpatasvirVenlafaxine and its saltsVerapamil (Iproveratril) and its saltsVildagliptinVinca alkaloids, their salts and derivatives; such as:Vinblastine and its saltsVincamineVincristine and its saltsVindesineVinorelbineVinpocetineViomycin, its salts and derivativesViral neuraminidase enzyme inhibitors, the following—Laninamivir, and its salts and derivativesOseltamivir, and its salts and derivativesPeramivir, and its salts and derivativesZanamivir, and its salts and derivatiesVitamins either alone or in combination, in preparations intended for injectionXanthinol nicotinateXipamideXylazine and its saltsYersinia ruckeri vaccine VZafirlukast and its saltsZaleplonZeranolZinc sulphate in preparations intended for ophthalmic useZipeprolZofenoprilZoledronic acid and its saltsZolpidemZopiclone and its saltsZuclopenthixol and its saltsAny drugs derived from any of the drugs referred to in this schedule, unless expressly excluded or unless listed in another schedule.Any drug or preparation not listed in the schedules.Herbal drugs, including plant parts, crude extracts, tinctures, mixtures, decoctions, concoctions; and processed or semi-processed derivatives thereof; (unless expressly excluded or unless listed in another schedule) in preparations intended for parenteral administration.

Group II

The following drugs and preparations containing such drugs may be supplied by retail only by a licensed person.Acetylcysteine, in preparations intended for oral use when labelled with a recommended daily dose not exceeding 1000 milligrams.^cetyldihydrocodeine - oral solid preparations, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of acetyldihydrocodiene (calculated as base) per dosage unit; and liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, and containing 0.4 percent w/v of acetyldihydrocodeine (calculated as base).Acetylsalicylic acid and its salts, in preparations intended for rectal application in strengths of more than 150 milligrams per dosage unit, but not exceeding 600 milligrams per dosage unitAcrivastineAlginic acid and its saltsAlverinAmbroxol HydrochlorideAmidines acaricides V such as Amitraz and CymiazoleAmino acids, in preparations intended for oral use, in concentrations exceeding the recommended dietary allowancesAminopentamide VAmodiaquine, when contained in preparations intended for oral useAmoxicillin and its salts, when combined with Clavulanic acid and its salts; in preparations intended for oral use, for a treatment period not below 5 days and not exceeding 7 daysAmylocaine and its salts, in preparations intended for topical use Antazoline and its saltsArtesunate, in preparations intended for oral administrationAtovaquone and its salts, in oral preparations intended for use in malaria prophylaxisAtropine; except as specified in group I of this classAttapulgiteAzatadineAzelastineBacitracin and its salts and derivatives, in preparations intended for application to the skinBamipineBeclomethasone dipropionate, when intended for nasal administration as an aqueous spray for use in adults and children over 12 years of age, subject to—

(a)maximum dose of 100 micrograms per nostril and a maximum daily dose of 200 micrograms of beclomethasone per nostril; and

(b)a maximum pack size of 200 dosesBenfotiamine and its saltsBenproperine VBenzocaine and its salts, when intended for topical applicationBenzoyl peroxide, when intended for topical applicationBenzydamine, and its saltsBetamethasone valerate either alone or in combination with one or more drugs listed in this group or in class C, in concentrations not exceeding 0.5 percent w/w in preparations intended for topical administrationBeta-sitosterol in preparations intended for topical applicationBifonazole, when intended for application to the skinBisacodyl and its saltsBismuth subgallateBitolterolBromhexine and its saltsBromodiphenhydramineBrompheniramineBuclizineBufexamac, in preparations intended for topical use ButinolineButoconazole in preparations intended for topical administrationCaffeine—

(a)in combination with one or more other drugs listed in this group; in concentrations not exceeding 65 milligrams per dosage unit.

(b)in combination with one or more other drugs listed in class C; in concentrations exceeding 65 milligrams per dosage unit.Cantharidin and its derivativesCarbacholCarbinoxamine and its saltsCarbocisteineCasanthranolCefalexin, in preparations intended for oral use, for a maximum treatment duration of 7 days.Celecoxib and its saltsCepae fluid extractClioquinol, in preparations intended for ophthalamic and topical administration Chlorcyclizine and its saltsChlorfenvinphos V"hloroquine, in oral preparations intended for malaria prophylaxis ilorpheniramine, and its salts in preparations intended for oral or topical use। nlorzoxazoneUholine SalicylateChondroitin and its saltsCinchocaine when contained in preparations intended for rectal administration CinnarizineClemastineClemizoleClidinium bromideClobetasol and its salts, either alone or in combination with one or more drugs listed in this group or in class C; in concentrations not exceeding 0.05 percent w/w in preparations intended for application to the skinClobetasone and its salts, either alone or in combination with one or more drugs listed in this group or in class C; in concentrations not exceeding 0.05 percent w/w in preparations intended for application to the skinCodeine (methylmorphine):

(a)in oral solid preparations, in combination with one or more drugs listed in this group or in class C, in concentrations not exceeding 10 milligrams (calculated as base) per dosage unit; in pack sizes not exceeding 10 dosage units.

(b)In liquid oral preparations and mixtures, in combination with one or more drugs listed in this group or in class C, in concentrations not exceeding 0.2 percent w/w, in pack sizes not exceeding 100 millilitres.Cromoglycic acid and its salts in solutions of sodium cromoglycate in concentrations not exceeding 2 percent w/v or less, for ophthalmic or intranasal useCyclizine, in preparations intended for oral useCyproheptadine and its saltsDehydroemetine; its saltsDemeton-S-methylDesloratadine and its saltsDexamethasone,

(a)either alone or in combination with one or more drugs listed in this group or in class C, in concentrations not exceeding 1 percent w/w in preparations intended for topical or ophthalmic use or in concentrations not exceeding 0.01 percent w/v in preparations intended for oral use

(b)as the only active therapeutic substance when contained in oral solid dosage forms not exceeding 0.5 milligrams per dosage unit DexchlorpheniramineDextroketoprofenDextromethorphan, and its salts except as specified in class CDextroiphan, and its saltsDiastaseDichlorvosDiclofenac when contained in:

(a)preparations intended for topical use in concentrations exceeding 1.16 percent w/w

(b)preparations intended for rectal administration

(c)oral solid dosage, immediate release preparations containing not more than 50 milligrams per dosage unit, in pack sizes not exceeding 10 dosage units.

(d)oral solid dosage, modified release preparations containing not more than 100 milligrams per dosage unit, in pack sizes not exceeding 10 dosage units.Dicyclanil VDicycloverine (Dicyclomine) and its salts, intended for topical useDihydroartemisininDihydrocodeine—

(a)oral solid preparations, in combination with one or more drugs listed in this group or in class C, in concentrations not exceeding 20 milligrams (calculated as base) per dosage unit; or

(b)liquid oral preparations and mixtures, in combination with one or more drugs listed in this group or in class C, in concentrations not exceeding 0.4 percent w/w (calculated as base).Dimenhydrinate and its salts for oral useDimethicone, its salts and derivatives when contained in oral liquid, oral solid or topical preparationsDimethoxanateDiosmectiteDiphenhydramine and its saltsDiphenylpyralineDocusateDoxylamine melilotus officinalis extractEbastineEmedastineEphedrine, and its salts in:

(a)concentrations not exceeding 1 percent w/v in preparations intended for nasal administration for a maximum treatment period of 5 days.

(b)concentrations not exceeding 0.15 percent w/v in liquid preparations intended for oral use, with daily doses not exceeding 50 milligrams.EpinastineErgotamine tartarate, in oral preparations in concentrations not exceeding 2 milligrams per dosage unit, with a maximum daily dose of 6 milligrams and no more than 10 milligrams per weekEsomeprazole and its salts, in oral preparations in concentrations not exceeding 20 milligrams per dosage unit when intended for a treatment period not exceeding 10 daysEtofenamateEuphorbia prostata extractFamotidine, in oral solid dosage forms in concentrations not exceeding 20 milligrams per dosage unit, in packs containing not more than 30 dosage units.Fenchlorphos VFexofenadine in preparations intended for oral useFluconazole in single dose oral preparations containing 150 milligrams or less of Fluconazole for the treatment of vaginal candidiasisFlurbiprofen:

(a)in preparations intended for topical use

(b)when intended for oral use in concentrations not exceeding 100 milligrams per dosage unit, and a maximum daily dose not exceeding 300 milligrams for a maximum treatment period of 5 daysFluticasone propionate, when intended for nasal administration as an aqueous spray for use in adults and children over 12 years, subject to a maximum daily dose of 100 micrograms per nostril and a maximum pack size of 120 dosage units.Gentamycin sulphate in concentrations not exceeding 0.1 percent w/w in preparations intended for application to the skin and in concentrations not exceeding 0.3 percent w/v in preparations intended for application to the eyeGinkgo biloba extractGlycerine (Glycerol)Gramicidin, its salts and derivatives in preparations intended for application to the skinGriseofulvin, in preparations intended for oral or topical useHeparin and its salts, when intended for topical useHomatropine and its salts when intended for oral use in concentrations not exceeding 2 milligrams per dosage unitHormones (natural or synthetic, including recombinant forms), with either hormonal, prohormonal or anti-hormonal action:

(a)as Levonorgestrel in concentrations of 1.5 milligrams or less per oral dosage unit, intended for emergency postcoital contraception, in pack sizes containing not more than 1.5 milligrams of levonorgestrel

(b)in oral preparations, either alone or in combination; when intended for emergency postcoital contraception

(c)when intended for oral contraception, except as specified in class CHyaluronic acid and its salts when intended for ophthalmic use in concentrations not exceeding 0.1 percent w/vHydroquinone; preparations and mixtures containing 2 percent or less thereof, when intended for application to the skin, and indicated foi management of melanin hyperpigmentation.Hydroxyethylcellulose, in preparations intended for ophthalmic use Hydroxyethyl starch, and its derivates in preparations intended foi ophthalamic useHydroxypropylmethylcellulose (Hypromellose), in preparations intended for ophthalmic useHyoscine and its salts; when contained in transdermal preparations or oral preparationsIbuprofen when contained in oral medicinal preparations in combination with one or more drugs listed in this group or in class C, in packs not exceeding 100 millilitres in volume or in solid preparations in packs not exceeding 10 dosage units, where the recommended daily dose of ibuprofen in the case of adults and children over 12 years does not exceed 1200 milligrams and in children from the age of 6 months up to 12 years does not exceed 20 milligrams per kilogramme of body weight.Indomethacin, when intended for topical or rectal application Ipecacuanha tincture Ispaghula husk Isoaminile, and its saltsIsothipendylKetoconazole, in preparations intended for application on the skin in concentrations not exceeding 2 percent w/wKetoprofen:

(a)in preparations intended for topical use

(b)when intended for oral use in concentrations not exceeding 25 milligrams per dosage unit, in pack sizes not exceeding 30 dosage units.LactuloseLansoprazole and its salts, in oral solid dosage forms in concentrations not exceeding 30 miligrams per dosage unit, in packs containing not more than 10 dsage units.Levocabastine, in preparations intended for ophthalmic application or nasal administrationLevocetirizine and its saltsLevosalbutamol when contained in pressurized aerosol preparations in concentrations not exceeding 50 micrograms per dosage unit, in pack sizes not exceeding 200 metered dosesLidocaine in preparations for topical use other than eye dropsLithium salts, when intended for application to the skinLoratadine and its saltsMacrogol (polyethylene glycol), when contained in preparations intended for oral or vaginal administration.Magnesium citrate, intended for oral use as a purgativeMagnesium salicylateMagnesium sulphate, in preparations intended for oral use, use as a laxative MebeverineMebhydrolinMeclizine (Meclozine) and its saltsMecysteineMefenamic acid as the only therapeutically active substance in oral formulations, when intended for use in adults and children over the age of 12 years, subject to a maximum daily dose of 1500 millligrams and a maximum treatment period of 5 days.Mefloquine, its salts and derivatives; in oral preparations intended for prophylaxis against Malaria infectionMelatonin, when used for the treatment of desyncronosis (jet-lag) in doses not exceeding 6 milligrams dailyMeloxicam, its salts and derivatives, in preparations intended for oral use, for a maximum treatment period of 5 days in adults and children aged 12 years and above, where the maximum daily dose does not exceed 15 milligrams.Mepivacaine and its salts when intended for topical useMequitazineMercury, preparations and mixtures that contain mercury metal and that are intended for external use in concentrations not exceeding 0.5 percent of mercuryMetamizole (Dipyrone)Metaproterenol (orciprenaline), except as specified in group 1 of this class.Metronidazole when contained in preparations:

(a). intended for topical application

(b)intended for oral administration as solid dosage forms, in concentrations not exceeding 400 milligrams per dosage unit, and supplied for a treatment duration not exceeding 7 days

(c)intended for oral administration as liquid dosage forms, in concentrations not exceeding 4 percent w/v, in pack sizes not exceeding 100 millilitres.Methylprednisolone and its salts, in concentrations not exceeding 0.25 percent w/w when contained in preparations intended for application to the skinMiconazole, when contained in preparations:

(a)intended for application to the skin; and

(b)intended for human vaginal use, specifically for the treatment of vaginal candidiasis; and

(c)intended for human use in preparations containing 2 per cent or less of miconazole, when intended for the topical treatment of fungal infections of the mouth (oral candidiasis).Mineral salts except as listed elsewhere in the schedules, either alone or in combination with vitamins, amino acids or other micronutrients as specified in this group, in preparations intended for oral use in concentrations above the recommended dietary allowancesMinoxidil, when contained in topical preparations, in concentrations not exceeding 5 percent w/vMizolastineMometasone furoate, when intended for nasal administration as an aqueous spray for use in adults and children above the age of 2 years, subject to: (a) a maximum dose of 200 micrograms per nostril in adults and 50 micrograms per nostril in children; and

(b)a maximum pack size of 200 doses.Mupirocin, in preparations intended for application to the skinNaphazoline except as specified in class CNaproxen:

(a)in preparations intended for application to the skin

(b)in oral solid dosage forms, in concentrations not exceeding 500 milligrams per dosage unit, and in packs containing not more than 20 dosage units.Neomycin and its salts, in concentrations not exceeding 0.5 percent w/w in preparations intended for topical or opthalamic administration.Nialamide, its saltsNicotine when intended for human medicinal use as an aid to smokingcessation, and presented:

(a)as nicotine gum or lozenges containing not more than 4 milligrams of Nicotine per piece,

(b)as metered sprays containing 1 milligram per dose or less, as nicotine transdermal patches for continuous application to the skin in strengths not exceeding 25 milligrams per 24 hours,

(c)as oral solid dosage forms containing 2 milligrams or less, or (d) as inhalers containing 10 milligrams or less per cartridge.NitrofurantoinNonoxynol-9Norcodeine-oral solid preparations, in combination with one or more therapeutically active substances, and containing 20 milligrams or less of Norcodeine (calculated as base) per dosage unit; or liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, and containing 0.4 percent w/v or less of norcodeine (calculated as base).Octatropine methylbromide Olopatadine and its salts omeprazole and its salts, in oral solid dosage forms in concentrations not exceeding 20 milligrams per dosage unit, in packs containing not more than 10 dosage units.Orlistat, in oral preparations containing not more than 60 milligrams per doage unit, and indicated for weight loss in overweight adults with a body mass index greater or equal to 28 kilogrammes per square meter, in doses not exceeding 180 milligrams per day.Orphenadrine citrateOrthocaine; its saltsOtilonium bromideOuabainOxatomideOxethazaine when contained in antiacid or antihemorroidal preparations Oxymetazoline and its salts, in preparations intended for nasal administration Oxyphencyclimine OxyphenoniumPapain (Papaya proteinase 1)Papaverine; substances, preparations and its mixtures for oral use Paracetamol:

(a)as the only active therapeutic substance in immediate release oral or rectal formulations containing more than 500 milligrams per dosage unit, where the recommended cumulative daily dose does not exceed 4000 milligrams

(b)as the only active therapeutic substance in modified release formulations

(c)in combination with one or more drugs listed in this group or in class C, in a solid dosage form contained in packs not exceeding 10 dosage units, for use in adults and children over 12 years of age where the cumulative daily dose of Paracetamol does not exceed 3250 milligrams.

(d)in combination with one or more drugs listed in this group or in class C in oral liquid preparations containing Paracetamol in a strength of not more than 5 percent w/v, in packs not exceeding 100 millilitres, intended for use in children aged 3 months and above.Penciclovir and its salts, in preparations intended for topical use for the treatment of herpes simplex virus infections of the lips and face (Herpes labialis) in adults and children over 12 years of age.’entoxyfyllinePeppermint (Mentha piperita) including leaf and oil when intended for oral or topical usePhenazone (antipyrine).Phenazopyr i dinePhenindaminePheniraminePhenylephrine, either alone or in combination with any other drug listed in this schedule or in class C; when contained in: (a) preparations for topical or rectal application

(b)solid preparations intended for oral use, in concentrations not exceeding 20 milligrams per dosage unit

(c)when contained in oral liquid preparations not exceeding 0.4 percent w/vPhenylpropanolamine (norephedrine), preparations and mixtures where the recommended daily dose for adults does not exceed 100 milligrams and for children 6 to 12 years does not exceed 50 milligrams, when intended for the symptomatic relief of nasal and sinus congestionPhenyltoloxamine and its saltsPholcodine, either alone or in combination with one or more drugs listed in this schedule or in class C in oral preparations in concentrations not exceeding 20 milligrams per dosage unit or 0.4 percent w/v.Pimethixene, preparations and mixtures thereof when used solely as an antihistaminePinaveriumPipenzolatePiperaquine and its saltsPipoxolanPiroxicam, its salts and derivatives in oral dosage forms in concentrations not exceeding 20 milligrams per dosage unit, in pack sizes not exceeding 10 dosage units.Pizotifen, preparations and mixtures, when intended for prophylaxis of migrainePodophyllum resin, preparations and mixtures containing 20 percent or less.Potassium permanganatePovidone iodine, for ophthalmic usePrifinium bromideProbiotics, containing microrganisms such as; Lactobacillus acidophilus, Bifidobacterium infantis, enterococcus faecium and Saccharomyces boulardiiProglumideProguanil, in oral preparations intended for malaria prophylaxisPromethazine, when intended for use:

(a)in preparations for application to the skin

(b)in preparations for oral use containing not more than 25 milligrams per dosage unit for solid formulations, and not more than 0.1 percent w/v for liquid formulations.Propantheline bromidePropyphenazonePseudoephedrine, either alone or in combination with one or more drugs listed in this group or in class C, when contained in:

(a)oral solid dosage forms in concentrations not exceeding 120 milligrams per dosage unit

(b)oral liquid dosage forms in concentrations not exceeding 1.2 percent w/v.Pyrethrins V, their salts and derivaties such as;AlphacypermethrinCyhalothrinCypermethrinDeltamethrinFlumethrinPermethrinPyrethrinPyrrobutamineRanitidine and its salts, when contained in oral solid dosage forms at a concentration not exceeding 150 milligrams per dosage unit in pack sizes containing not more than 30 dosage units.Retapamulin, when intended for topical application to the skin, nares and external earRupatadine and its saltsSalbutamol:

(a)when contained in pressurized aerosol preparations in concentrations not exceeding 200 micrograms per dosage unit, in pack sizes not exceeding 200 metered doses

(b)either alone or in combination with any drug listed in this group or in class C, in oral liquid preparations in concentrations not exceeding 0.04 percent w/vSerratiopeptidaseSilver nitrate, when intended for topical applicationSilymarinSimethicone, its salts and derivatives when contained in oral liquid, oral solid or topical preparationsSodium bisphosphate when contained in oral and rectal preparations, and intended for use as a purgativeSodium chlorateSodium chloride when formulated at a concentration on 0.9 percent w/v, in preparations intended for ocular irrigationSodium phosphate when contained in oral and rectal preparations, and intended for use as a purgativeSorbitol, except as specified in group II of this classSulfo tepTerbinafine and its salts, in preparations intended for topical administrationTerbutaline, either alone or in combination with any drug listed in this group or in class C, in oral liquid preparations in concentrations not exceeding 0.05 percent w/vTetracaine when contained in preparations intended for oral, rectal or topical application to the skinTetracycline and its salts, in preparations intended for topical administration Tetrahydrozoline for ophthalamic useThiethylperazine, in oral preparations for relief of nausea and vomiting Tiaprofenic acid, in concentrations not exceeding 300 milligrams per dosage unit when intended for a maximum treatment period of 5 daysTimepidium in preparations intended for oral useTioconazole and its salts in preparations intended for application to the skin and in preparations intended for intra-vaginal useTolpropamineTriamcinolone acetonide when contained in nasal spray formulations delivering not more than 55 micrograms per spray, intended for use by adults and children over the age of 12 years.Tribenoside when contained in preparations intended for rectal administration TricholineTrichloroacetic acid.TrimebutineTripelennamineTriprolidine, except as specified in class CTrospiumTyrothricin, when used in oral preparations for symptomatic relief of soar throatUrea when contained in preparations intended for application on the skinVaccines, sera, toxins, antitoxins and antigens for human use; except as specified elsewhere in the schedules; the following:Diphtheria toxoid vaccineHaemophilus influenza vaccineHepatitis B vaccineHuman papillomavirus vaccineInfluenza virus vaccineMumps vaccinePertussis toxoid vaccinePneumococcal vaccine, conjugatedPneumococcal vaccine, polysaccharidePolio vaccineRabies antiseraRabies vaccineRota virus vaccineRotavirus, live attenuated vaccineRubella vaccineTetanus toxoid vaccineTuberculosis (Bacillus Calmette-Guerin) vaccineYellow fever vaccineVaccines, sera, toxins, antitoxins and antigens for veterinary use; except as specified elsewhere in the schedules; the following:Bovine Contagious Pleuropneumonia vaccine VFoot and Mouth disease vaccines VLumpy Skin disease vaccine VNewcastle disease vaccine VRinderpest vaccine VRabies vaccine VVitamin Bl (Thiamine), and its derivatives; in preparations intended for oral useVitamin B2 (Riboflavin), and its derivatives; in preparations intended for oral useVitamin B3 (Niacin), and its derivatives; in preparations intended for oral useVitamin B5 (Pantothenic acid), and its derivatives; in preparations intended for oral useVitamin B6 (Pyridoxine), and its derivatives; in preparations intended for oral useVitamin B12 (Cobalamin), and its derivatives; in preparations intended for oral useVitamins (except as specified elsewhere in the schedules), either alone or in combination, in preparations intended for oral use, in concentrations above the recommended dietary allowances.Water for injectionWater for irrigationXylometazoline; in preparations intended for nasal administrationYohimbe, alkaloids of, such as YohimbineZinc pyrithione, in preparations intended for topical useHerbal drugs, including plant parts, crude extracts, tinctures, mixtures, decoctions, concoctions; and processed or semi-processed derivatives thereof; (unless expressly excluded or unless listed in another schedule) in preparations intended for topical or oral use; except as specified in class C. Any substances derived from any of the medicines referred to in this schedule, unless expressly excluded.

Schedule 4 (Sections 12, 60(2))

Class C drugs

The following drugs, except such as are in a form suitable for administration by injection are the drugs included in this Schedule. They may be sold by retail only by a person or company operating as a licensed person or a licensed seller, but in the case of the latter only in accordance with the terms of his or her license.

Group I

Acetylsalicylic acid and its salts:

(a)in preparations intended for application on the skin

(b)either alone or in combination with one or more drugs listed in this class, intended for oral use in concentrations ranging from 300 milligrams to 600 milligrams per dosage unit subject to a maximum daily dose of 2400 milligrams subject to a maximum treatment period of 5 days.

AcriflavineActivated charcoalAcyclovir and its salts, in preparations intended for topical useAlbendazole in preparations intended for oral useAlexidineAllantoinAmmonium chloride, except as specified in group I of this class Amoxicillin, its salts; in preparations intended for oral use AmylmetacresolAntacid preparations containing compounds such as;Aluminium hydroxideBismuth saltsCalcium carbonateMagaldrateMagnesium carbonateMagnesium hydroxideMagnesium sulphateMagnesium trisilicateSodium alignateSodium bicarbonateSodium carbonateAnti histamines as listed in class B group II but only when contained in preparations for external application only other than for the eyes or nose and in preparations containing not less than 1 percentAntibiotics, when contained in preparations or concentrates for animal feedstuffsArsenic, in preparations containing less than the equivalent of 0.01 percentof arsenic trioxide, and dentifrices containing less than 0.5 percent of acetarsolArtemether in combination with Lumefantrine, in oral preparations for parasitologically diagnosed uncomplicated malariaArtesunate, in preparations intended for rectal administrationBenzalkonium, and its saltsBenzocaine, when contained in lozenge preparationsBenzoic acidBenzyl AlcoholBenzyl benzoate for topical useBoric acid for topical useBrucine, when contained in surgical spirit containing not more than 0.2 percent of brucineCaffeine, in combination with one or more other drugs listed in this class; in concentrations not exceeding 65 milligrams per dosage unit.Calamine lotionCamphor oils in preparations intended for topical useCandicidinCastor oilCetalkonium, and its saltsCetirizine and its saltsCetrimideCetylpyridinium chlorideChlorhexidine and its saltsChloramphenicol in preparations formulated as eye/ear dropsChloroform, in preparations containing not more than 0.5 percent w/v of chloroformCitric acidClotrimazoleCoal tarCrotamitonDexpanthenol in preparations intended for topical useDextromethorphan when contained in oral preparations in concentrations not exceeding 10 milligrams per dosage unit or 0.2 percent w/v 2, 4 dichlorobenzyl alcoholDiazepam, in preparations intended for rectal administrationDichlorophenDiclofenac when contained in preparations intended for topical use in concentrations not exceeding 1.16 percent w/wDidecyl dimethyl ammonium chlorideDinitolmide VDioctyl dimethyl ammonium chloride enilconazole, for topical useErythromycin and its salts, in preparations intended for oral useEthanol, in concentrations exceeding 70 percent w/v in preparations intended for oral or topical useEthinyl estradiol when used in combination with levonorgestrel in oral preparations intended for contraceptionEthylenediamine dihydroiodide VFenbendazole VFerric and ferrous salts, and their combinations when contained in preparations for oral useFipronil V when used in spot-on solutions for topical use in concentrations not exceeding 10 percent w/vFolic acidGentian VioletGlutaraldehyde, when contained in topical preparations in concentrations not exceeding 10 percent w/wGuaifenesin (Glyceryl guaiacolate)Hyaluronic acid and its salts, when contained in topical preparationsHydrocortisone either alone or in combination with one or more drugs in this class, in concentrations not exceeding 1 percent w/w in preparations intended for application to the skin.Hydrogen peroxide solution for topical useHyoscyamine, in preparations containing less than 0.15 percent of hyoscyamine in preparations intended for topical useIbuprofen:

(a)when contained in preparations intended for application to the skin

(b)as the only active therapeutic substance, in a solid dose form contained in packs not exceeding 20 dosage units for use in adults and children over 12 years of age where the recommended daily dose of ibuprofen does not exceed 1200 milligrams

(c)when contained in oral liquid preparations as the only active therapeutic substance in packs not exceeding 100 millilitres in volume when intended for children over the age of 1 year but not exceeding 12 years; where the recommended daily dose of ibuprofen does not exceed 20 milligrams per kilogramme of body weight

(d)in combination with one or more drugs listed in this Schedule, in a solid dose form contained in packs not exceeding 10 dosage units, for use in adults and children over 12 years of age where the recommended daily dose of ibuprofen does not exceed 1200 milligrams

Idoxuridine, when intended for application to the skinIodine tincture, for topical useIsopropanolKaolinKetoconazole, in preparations for topical use as shampoos in concentrations not exceeding 2 percent w/vLanolinLevamisole and its salts for oral useLevomentholLidocaine when contained in oral lozengesLindane for topical use liquid ParaffinLiquorice root extact (Glycyrrhiza glabra) in preparations intended for use in the relief of the symptoms of mucus coughs and coldsLoperamide 2 milligrams oral formulations intended for short-term relief of non-infectious diarrhea.Lozenges for common cold and coughLufenuron VLugol’s iodineMalathion for topical useMebendazoleMedroxyprogesterone acetateMentholMepyramineMetacresol sulphonic acid for topical useMethyl nicotinate for topical useMethy salicylate in preparations for topical useMethylated spirit (Denatured alcohol)Metriphonate VMonensin VMoxidectin for topical use VMultivitamin preparations intended for oral use, containing a combination of two or more of the following vitamins or their derivatives;Vitamin AVitamin BVitamin CVitamin DVitamin ENaphazoline for nasal useNystatin:

(a)when intended for vaginal application in the initial treatment of vaginal candidiasis

(b)when intended for application to the skin, nares, and external ear

(c)when contained in preparations intended for oral administration Octyl 2-cyanoacrylate, when used as a wound barrier and closure adhesive.

Oral Rehydration SaltParacetamol in preparations intended for oral or rectal use:

(a)as the only active substance in immediate release formulations containing not more than 500 milligrams per dosage unit, in pack sizes not exceeding 20 dosage units or in liquid preparations containing not more than 5 percent w/v in pack sizes not exceeding 100 millilitres

(b)in combination with one or more drugs listed in this Schedule, in a solid dosage form contained in packs not exceeding 10 dosage units, for use in adults and children over 12 years of age where the cumulative daily dose of Paracetamol does not exceed 2000 milligrams

Parathion VP-chlorocresolPectinPhenylephrine, either alone or in combination with any other drug listed in this Schedule:

(a)when contained in solid preparations intended for oral use, in concentrations not exceeding 10 milligrams per dosage unit

(b)when contained in oral liquid preparations not exceeding 0.2 percent w/v

Pholcodine in preparations containing not more than 1 percent w/v of pholcodinePiperazine and its saltsPovidone iodine, in topical preparationsPseudoephedrine, either alone or in combination with one or more drugs listed in this Schedule, when contained in:

(a)oral solid dosage forms in concentrations not exceeding 60 milligrams per dosage unit

(b)oral liquid dosage forms in concentrations not exceeding 0.6 percent w/v

Salbutamol;

(a)as the only active therapeutic substance contained in oral liquid preparations in concentrations not exceeding 0.04 percent w/v when used for relief of bronchospasm in bronchial asthma

(b)when contained in oral solid preparations in concentrations not exceeding 4 milligrams per unit dose, when used for relief of bronchospasm in bronchial asthma

Salicylic acid, in preparations for topical applicationSchradanSelenium Sulphide in topical preparations in concentrations not exceeding 2.5 percent w/vSenna and its preparationsSodium borate (Borax)Sodium citrate when contained in oral cough preparations as a mucolytic agentSodium chloride when formulated alone in preparations intended for nasal administrationSulfadiazine silver when intended for application to the skin in the shortterm treatment of minor bums, subject to a maximum pack size of 30 gramsSulphur contained in preparations for topical administrationSyzygium aromaticum (clove oil) in preparations intended for topical useTartaric acidTetracaine when contained in lozenges in concentrations not exceeding 0.2 milligrams per dosage unitTolnaftateTetracycline ointment for ophthalmic use, in adults and children above 12 years of ageTibezonium and its salts in preparations for topical useThymolTolnaftate, intended for topical applicationTriprolidine, either alone or in combination with any other drug listed in this Schedule when contained in:

(a)oral solid dosage forms in concentrations not exceeding 2.5 milligrams per dosage unit

(b)oral liquid dosage forms in concentrations not exceeding 0.025 percent w/v

Turpentine oils in preparations intended for application on the skin undecyclenic acid for topical application.Vitamin A, in preparations for oral useVitamin C, in preparations intended for oral useWintergreen oil in preparations intended for topical use.Zinc oxideZinc sulphate in preparations intended for oral administrationHerbal drugs, including plant parts, crude extracts, tinctures, mixtures, decoctions, concoctions; and processed or semi-processed derivatives thereof; (except as specifically listed in the schedules) in preparations intended for—

(a)topical application, where not indicated or otherwise associated with the management of any condition specified in Schedule 6 of this Act;

(b)oral administration specifically intended for relief of mild to moderate coughs, flu, colds, pains and fever; and where not indicated or otherwise associated with the management of any condition specified in Schedule 6 of this Act.

Schedule 5 (Sections 12, 60(2))

Exempted drugs and articles

The following drugs and articles are known as exempted drugs and articles.AdhesivesAmmonia, substances containing less than five percent of ammonia, refrigerators.Antifouling compositionsAntimony, chlorides of, when contained in polishesBatteries and accumulatorsBuilders’ materialsCeramicsChemicals not included in Class A, B or C when packed and labelled for culinary and cooking purposesCreasote, obtained from coal tarCentrifricesDistempersDressings on seeds or bulbsElectrical valvesEnamelsExplosivesFireworksFitters, fire extinguishersFluorescent lampsFormaldehyde, when in photographic glasing or hardening solutionGlazesGlueInksLacquer solventsLaundry materials; blue, bleaches and starchLoading materialsMatchesMedicated soapMotor fuels and lubricantsNitrobenzene, when contained in polishesOxalic acid and metallic ozalates when contained in polishes and cleaning powdersPaints (other thin pharmaceutical paints)Phenylmercuric salts, when used in a concentration not exceeding 0.01 percent in toilet and cosmetic preparations as a preservative or in textiles or antiseptic dressings as a bacteriostat or fungicidePhotographic paperPigmentsPlasticsPropellantsRubberTar (coal or wood)TobaccoVarnishes

Schedule 6 (Sections 33, 60(2))

Diseases as to which publication of descriptive matter is restricted or prohibited

1.Syphilis, gonorrhoea, soft chancre and any form of genitourinary disease or other diseases connected with the human reproductive functions.

2.Any of the following—

Amenorrhoea	Kidney stones
Arteriosclerosis	Leprosy
Bladder stones	Locomotorataxy
Blindness	Lupus
Brights’ disease	Nephritis or Brights’ disease
Cancer	Paralysis
Cataract	Pleurisy
Deafness	Pneumonia
Diabetes	Poliomyelitis
Diphtheria	Scarlet fever
Dropsy	Schistosomiasis
Epilepsy or fits	Septicaemia
Erysipelas	Smallpox
Gallstones	Tetanus or lockjaw
Glaucoma	Trachoma
Goitre	Tuberculosis or consumption
Heart disease	Any structural organic ailment of the auditory system
Hernia or rupture	Any structural organic ailment of the auditory system

Schedule 7 (Sections 38(4), 60(2))

Preparations that may be manufactured by, or under the supervision of, a duly qualified medical practitioner

1.Preparations containing extracts of pituitary, suprarenal, thyroid, liver, pancreas or parathyroid glands, or stomach.

2.Preparations containing the active principles of any of the aforesaid glands or the salts of the active principles of any of those glands.

Schedule 8 (Sections 42, 60(2))

Requirements as to the storage of classified drugs

1.All Class B and Class C (Group II) drugs and preparations except when in use shall be kept—

(a)under secure lock and key—

(i)in a separate room or compartment specially reserved for keeping these drugs and partitioned off from the rest of the premises; or

(ii)in a suitable cupboard, box or other receptacle specifically reserved for keeping drugs, and kept in a place apart from anything containing food or drink; and

(b)the drugs shall be kept in a place ordinarily accessible only to the person in charge of the drugs, or to some person under his or her immediate supervision and control; and

the key of the room, compartment, cupboard, box or other receptacle in which these drugs are kept shall be retained under the control of the person in charge of the drugs.

2.All Class A drugs and preparations shall, except when in use, be stored in a separate store or cupboard apart from all other drugs, in accordance with the requirements of paragraph 1 above, except that if stored in a cupboard or similar receptacle the cupboard or other receptacle shall be so fixed in position as to be immovable.

3.No Class A, Class B (Group I) or Class C (Group II) drugs shall be kept in a part of any premises to which members of the general public normally have access.

4.All drugs and preparations for external use shall be kept separate from drugs and preparations intended for internal use.

Schedule 9 (Sections 43(1), 60(2))

Consignment and transportation of classified drugs

1.No person shall consign for transport any drug specified in this Schedule, unless the outside of the package is labelled conspicuously with the name or description of the drug and a notice indicating that it is to be kept separate from food and from empty food containers.

2.No person shall, knowingly, transport any drug specified in this Schedule in any vehicle in which food is being transported, unless the food is carried in a part of the vehicle effectively separated from that containing the drug, or is otherwise adequately protected from the risk of contamination.AldrinAluminium phosphideArsenical preparationsBarium, salts ofDieldrinDinitrocresols (DNOC), their compounds with a metal or base when contained in preparations for use in agriculture or horticultureDinosam, its compounds with a metal or base when contained in preparations for use in agriculture or horticultureDinoset, its compounds with a metal or base when contained in preparations for use in agriculture or horticultureEndosulfanEndothal, its saltsEndrinEthylene dibromide; ethylene dichlorideFluoroacetamide, fluoroacetanilideHydrocyanic acid, cyanidesMercury, its halides when contained in preparations for use in agriculture or horticultureMethyl bromideMonofluoroacetic acid; its saltsNicotine; its saltsOrgano tin compounds, the following compounds of gentin Phosphorous compounds, the following—Amiton, azinphos-ethyl, azinphos-methyl; chlorgenrinphos; demeton-O-methyl; demeton-O; demeton-S; demeton-S-methyl, diazinon, dichlorvos, diethyl 4-methyl-7-coumarinyl phosphorothianate, diethyl-p-nitrophenyl phosphate; dimefox; disulfotam ointment; disulfoton; ethion; ethyl-pitrophenyl, phenylphosphonothionate; mazidox, mecarbam, mevinphos, mipafox, oxydematon-methyl; parathon, phenkapton, photate, phosphamidon schradon, sulfetep, TEPP, HEPP, thionazin, triphosphoric pentadimethylamide; vamidothionSelenium; its compounds when contained in preparations for use in agriculture or horticultureStrychnineThallium, salts of

History of this document

31 December 2023 this version

Chapter 198

Revised Laws 2023

Consolidation

28 July 2023

Amended by Law Revision (Miscellaneous Amendments) Act, 2023

15 February 2016

Amended by Narcotic Drugs and Psychotropic Substances (Control) Act

Read this version

31 December 2000

Chapter 206

Revised Laws 2000

Consolidation

Read this version

03 December 1993

Commenced

Subsidiary legislation

Title
National Drug Policy and Authority (Fees) Regulations, 2022	Statutory Instrument 5 of 2022
National Drug Policy and Authority (Surgical Instruments and surgical appliances) Regulations, 2019	Statutory Instrument 77 of 2019
National Drug Policy and Authority (Pharmacovigilance) Regulations, 2014	Statutory Instrument 37 of 2014
National Drug Policy and Authority (Suitability of Premises) Regulations, 2014	Statutory Instrument 36 of 2014
National Drug Policy and Authority (Licensing) Regulations, 2014	Statutory Instrument 35 of 2014
National Drug Policy and Authority (Importation and Exportation of Drugs) Regulations, 2014	Statutory Instrument 34 of 2014
National Drug Policy and Authority (Conduct of Ectoparasiticides Field Trials) Regulations, 2014	Statutory Instrument 30 of 2014
National Drug Policy and Authority (Registration) Regulations, 2014	Statutory Instrument 29 of 2014

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National Drug Policy and Authority Act

Chapter 198

National Drug Policy and Authority Act

Related documents

National Drug Policy and Authority Act

Chapter 198

Part I – Interpretation

1. Interpretation

Part II – National Drug Policy and national drug Authority

2. National Drug Policy

3. Establishment of National Drug Authority

4. Application of seal

5. Functions of Drug Authority

6. Commission and other bodies of Drug Authority

7. Meetings of Drug Authority

Part III – Control of drug supply

8. National list of essential drugs

9. Selection of drug items

10. Estimation of drug needs

11. Drug nomenclature

12. Restricted drugs

13. Supply and dispensing of restricted drugs

14. Licensed persons

15. Licensed sellers

16. Places from which restricted drugs may be supplied

17. Certificate of suitability of premises

18. Loss of Class A or B drugs

Part IV – Special provisions relating to classified drugs

19. Classified drugs

20. Need for prescription for classified drugs

21. Action to be taken in relation to prescription

22. Classified drugs to be supplied to responsible persons

23. Supply to conform to prescription

24. Classified Drugs Book

25. Containers and labels

26. Further restrictions on the supply of narcotics

27. Possession of classified drugs

28. Withdrawal of authority

29. Drug addicts

Drugs generally

30. Impure drugs not to be supplied

31. Power to call for information as to proprietary drugs

32. Power to prohibit retail sale of proprietary drugs

33. Control of publication of descriptive matter

34. Return of details of pharmacy business

35. Drug regulation and registration of specialities

36. Drug quality

Wholesale trade

37. Licence required for wholesale supply of restricted drugs

Control of manufacture and storage of drugs

38. Restrictions on manufacture of classified drugs

39. Further restrictions on manufacture of drugs

40. Clinical trials

41. Local research and production

42. Storage

Part V – Control of transport, import and export of drugs

43. Transportation of drugs

44. Importation of pharmaceuticals

45. Exportation of drugs

46. Import and export licences

Part VI – Powers of entry and investigation

47. Powers of entry

48. Powers of investigation

49. Authority to be shown

50. Obstruction

Part VII – Secretariat and financial provisions

51. Secretariat

52. Funds of Drug Authority

53. Estimates

54. Accounts

55. Audits

Part VIII – Miscellaneous

56. Rational use of drugs

57. Offences and penalties

58. Vicarious criminal responsibility

59. Evidence

60. Drugs Bureau

61. Regulations

62. Power to amend Schedules

Schedule 1 (Sections 1, 62(1))