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NATIONAL DRUG POLICY AND AUTHORITY ACT.

ARRANGEMENT OF SECTIONS.

   Section

PART I
INTERPRETATION.

   1.   Interpretation.

PART II
NATIONAL DRUG POLICY AND NATIONAL DRUG AUTHORITY.

   2.   National drug policy.

   3.   Establishment of the National Drug Authority.

   4.   Application of the seal.

   5.   Functions of the drug authority.

   6.   Commission and other bodies of the authority.

   7.   Meetings of the drug authority.

PART III
CONTROL OF THE 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.   Certificates 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 the 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
FURTHER RESTRICTIONS ON NARCOTICS.

   47.   Possession of narcotics.

   48.   Smoking of opium or Indian hemp.

   49.   Cultivation of plants yielding narcotics.

PART VII
POWERS OF ENTRY AND INVESTIGATION.

   50.   Powers of entry.

   51.   Powers of investigation.

   52.   Authority to be shown.

   53.   Obstruction.

PART VIII
THE SECRETARIAT AND FINANCIAL PROVISIONS.

   54.   Secretariat.

   55.   Funds of the drug authority.

   56.   Estimates.

   57.   Accounts.

   58.   Audits.

PART IX
MISCELLANEOUS PROVISIONS.

   59.   Rational use of drugs.

   60.   Offences and penalties.

   61.   Vicarious criminal responsibility.

   62.   Evidence.

   63.   Drugs bureau.

   64.   Regulations.

   65.   Amendment of Schedules.

      First Schedule   Class A drugs or narcotics.

      Second Schedule   Class B drugs or controlled drugs.

      Third Schedule   Class C licensed drugs.

      Fourth Schedule   Exempted drugs and articles.

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

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

      Seventh Schedule   Requirements as to the storage of classified drugs.

      Eighth Schedule   Consignment and transportation of classified drugs.

CHAPTER 206
THE NATIONAL DRUG POLICY AND AUTHORITY ACT.

Commencement: 3 December, 1993.

   An Act to establish a national drug policy and a 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.

PART I
INTERPRETATION.

1.   Interpretation.

   In this Act, unless the context otherwise requires—

   (a)   "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;

   (b)   "approved institution" includes gazetted hospitals, health centres, dispensaries, aid posts, registered medical clinics and nursing homes;

   (c)   "authorised person" means a person authorised under this Act;

   (d)   "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;

   (e)   "class A drug", "class B drug" and "class C drug" shall be construed in accordance with section 12;

   (f)   "classified drug" means a class A, B or C drug;

   (g)   "commission" means the National Drug Authority Commission;

   (h)   "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;

   (i)   "disease" includes injury and bodily or mental deficiency or abnormality;

   (j)   "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;

   (k)   "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;

   (l)   "drug authority" means the National Drug Authority;

   (m)   "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;

   (n)   "generic name" means the International Nonproprietary Name (INN) established by a body of the World Health Organisation;

   (o)   "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;

   (p)   "inspecting officer" means a person empowered under Part VII of this Act to enter any premises;

   (q)   "international control" means the international conventions on the control of narcotic drugs and psychotropic substances;

   (r)   "International Nonproprietary Name (INN)" means the official name of a drug, regardless of the manufacturer;

   (s)   "licensed person" means a person licensed under section 14;

   (t)   "licensed seller" means a person licensed under section 15;

   (u)   "manufacture" includes any treatment of a plant, mineral or other substance for the purpose of extracting a drug;

   (v)   "Minister" means Minister responsible for health;

   (w)   "narcotic drug" means a class A drug or preparation;

   (x)   "pharmacist" means pharmacist under the Pharmacy and Drugs Act;

   (y)   "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;

   (z)   "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;

   (aa)   "register" means the register of specialities maintained under the drug authority;

   (bb)   "restricted drug" means a classified drug or any other drug which is not an exempted drug;

   (cc)   "substance" includes a preparation;

   (dd)   "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 the National Drug Authority.

   (1) There is established a 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 other persons—

   (a)   the director of medical services;

   (b)   the commissioner for veterinary services;

   (c)   the commissioner for commissioner for trade;

   (d)   the director, criminal investigation department;

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

   (f)   the chief of pharmaceuticals and health supplies;

   (g)   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;

   (k)   two other 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 but shall be eligible for reappointment.

4   Application of the 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 the 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 the 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 from time to time, the working procedure of the drug authority;

   (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;

   (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 National Bureau of Standards;

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

      (i)   physician;

      (ii)   surgeon;

      (iii)   paediatrician;

      (iv)   gynaecologist/obstetrician;

      (v)   psychiatrist.

7.   Meetings of the 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 THE 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, from time to time, approve.

   (3) No person shall 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 Nonproprietary Names (generic names) except where no such name has been allocated and no satisfactory nonproprietary alternative exists.

12.   Restricted drugs.

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

   (a)   the drugs specified in the First, Second and Third Schedules to this Act shall be classified drugs;

   (b)   the drugs and articles specified in the Fourth Schedule 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 the First, Second or Third Schedule, 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 the First, Second or Third Schedule 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;

   (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 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 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) A person who carries on the business of a pharmacist without a licence issued under this section commits an offence and is liable to a fine not exceeding one million shillings or to imprisonment not exceeding five years or to both.

15.   Licensed sellers.

   (1) If, on application mad

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