CHAPTER 219
PHARMACEUTICAL AND POISONS ACT

[PRINCIPAL LEGISLATION]

ARRANGEMENT OF SECTIONS

   Section

Title

PART I
PRELIMINARY PROVISIONS

   1.   Short title.

   2.   Interpretation.

PART II
PHARMACY

The Pharmacy Board and Registration of Pharmacists

   3.   Establishment of Board.

   4.   Functions of Board.

   5.   Power of Board to cancel or suspend registration.

   6.   Appointment and functions of Registrar.

   7.   Register of pharmacists.

   8.   Qualifications for registration.

   9.   Provisional registration.

   10.   Temporary registration.

   11.   Certificate of registration.

   12.   Publication of registered particulars and lists of pharmacists.

   13.   Publication sufficient evidence of registration.

   14.   Registrar may call for information.

Restriction on Activities of Pharmacists

   15.   Restriction on use of certain titles.

   16.   Bodies of persons operating as pharmacists.

   17.   Definition of "carrying on business" or "practising as pharmacist".

   18.   Restriction on directions by Board.

   19.   Control of recruitment and activities of medical representatives.

PART III
MANUFACTURE OF PHARMACEUTICAL

Licensing of Manufacturers

   20.   Restriction on manufacture of pharmaceutical.

   21.   Register of manufacturers of pharmaceutical.

   22.   Application for and grant of licence to manufacture pharmaceutical.

Registration of Premises

   23.   Registration of premises for manufacture of pharmaceutical and for other business of pharmacists.

   24.   Application for registration.

PART IV
DEALINGS IN PHARMACEUTICALS AND POISONS

Composition of Pharmaceutical

   25.   Regulations regarding the composition of pharmaceutical.

   26.   Prohibition on preparation and sale on adulterated pharmaceutical.

   27.   General protection for purchasers of pharmaceutical.

Pharmaceutical Unfit for Use by Man

   28.   Offences regarding sale of pharmaceutical unfit for use by man.

   29.   Pharmaceutical offered as prizes.

Importation of Pharmaceutical

   30.   Restriction on importation of pharmaceutical, etc.

   31.   Application and conditions for registration.

   32.   Publication of registered particulars of importers of pharmaceutical.

Poisons

   33.   List of poisons for purposes of Act.

   34.   Conditions for pharmacist to become authorised seller of poisons.

   35.   Conditions for body corporate to become authorised seller of poisons.

   36.   List of shops and pharmacists in charge.

   37.   Possession of Part I poisons prohibited in certain cases.

   38.   Wholesale dealer's licence.

   39.   Licence to deal in poisons for mining, agricultural or horticultural purposes.

   40.   Power to sell Part I poisons.

   41.   Poisons Book.

   42.   Supply and dispensing of Part I poisons by doctors and hospitals.

   43.   Licence to sell Part II poisons.

   44.   Power to sell Part II poisons.

   45.   Poisons not to be sold in automatic machines.

   46.   Disposal of stocks by disentitled persons.

Labelling and Advertisement

   47.   Labelling of containers.

   48.   Labelling of articles containing medicine.

   49.   Prohibition of advertisements as to certain diseases.

   50.   Prohibition of advertisements as to abortion.

   51.   False labelling and advertisement.

PART V
ENFORCEMENT AND LEGAL PROCEEDINGS

Sampling and Analysis

   52.   Power to take samples.

   53.   Right to have sample analysed.

   54.   Provisions regarding the taking of samples for analysis.

   55.   Where division of sample into parts impracticable.

Enforcement

   56.   Appointment of inspectors.

   57.   Power of inspectors.

   58.   Power to prohibit or control certain medicines.

Legal Proceedings

   59.   Certificate of analysis.

   60.   Evidence of analysis.

   61.   Presumptions.

   62.   When warranty may be pleaded as defence.

   63.   Offences in relation to warranties or certificates of analysis.

   64.   Recovery of expenses incidental to taking of samples.

   65.   Forfeiture.

   66.   Appeals.

   67.   Right to carry on business pending appeal.

PART VI
MISCELLANEOUS PROVISIONS

   68.   Substances used in local system of therapeutics.

   69.   Liability of members of Board.

   70.   Power to delegate.

   71.   Regulations.

   72.   By-laws by Board.

   73.   General penalty.

PART VII
REPEAL AND CONSEQUENTIAL PROVISIONS

   74.   [Repeal of R.L. Caps. 93 and 416.]

   75.   Savings.

   76.   Transitional provisions.

SCHEDULES

CHAPTER 219
THE PHARMACEUTICAL AND POISONS ACT

An Act to provide for the control of the profession of pharmacy, and of matters relating to dealings in pharmaceuticals and poisons.

Acts Nos.
9 of 1978
1 of 1981

[1st March, 1979]
[G.N. No. 19 of 1979]

PART I
PRELIMINARY PROVISIONS (ss 1-2)

1.   Short title

   This Act may be cited as the Pharmaceutical and Poisons Act.

2.   Interpretation

   (1) 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;

   "authorised seller of poisons" means any of the persons declared by sections 34 and 35 to be authorised sellers of poisons;

   "Board" means the Pharmacy Board established by section 3;

   "British Pharmaceutical Codex" and "British Veterinary Codex" mean, respectively, the current edition, and any amendments made to them, of the books published by these names by the Pharmaceutical Society of Great Britain;

   "British Pharmacopoeia" means the current edition, and any amendments made to it from time to time, of the book published by that name in pursuance of section 47 of the Medical Act, 1956, of the United Kingdom or any enactment replacing it;

   "certificate of registration" means the certificate issued to a pharmacist under section 11 upon his being registered by the Board;

   "dispense" in relation to a medicine, pharmaceutical product or poison means to supply a medicine, pharmaceutical product or poison on and in accordance with a prescription lawfully given by a qualified medical practitioner, dentist or veterinary surgeon;

   "drug" includes any medicine, medicinal preparation or therapeutic substance;

   "for use by man" means for human consumption or for external application to the human body;

   "Government Analyst" means the Government Chemist and any analyst appointed by the Minister for the purposes of this Act;

   "labelled" means distinctly labelled in English or Latin and in Kiswahili;

   "manufacture", with its grammatical variations and cognate expressions, means to subject any physical article or substance commonly used to prepare drugs or other pharmaceutical products, to any process, including preparation and compounding, which results in that article or substance being possibly of use by man as a pharmaceutical product or poison, whether or not on a lawfully given prescription;

   "medicine" means any medicament or curative or preventive substance whether proprietary or in the form of a preparation;

   "member" in relation the to Board means a member of the Pharmacy Board and includes the Chairman and the Vice-Chairman;

   "Minister" means the Minister for the time being responsible for matters relating to health and medical services;

   "pharmaceutical" and "pharmaceutical product" means any drug, substance or other article manufactured or prepared in any way and intended for use by man as a medicine or as a remedy used for the purposes of medical, dental or veterinary treatment;

   "pharmacist" means a pharmaceutical chemist or a chemist and druggist who is registered under this Act;

   "Pharmacopoeia" means the current edition, and any amendments made to it from time to time, of the book published by that name by the World Health Organisation;

   "poison" means a pharmaceutical product included in the Poisons list referred to in section 33;

   "qualified" in relation to a medical practitioner, dentist or veterinary surgeon, as the case may be, means a medical practitioner or dentist registered under the Medical Practitioners and Dentists Act * and a Veterinary Surgeon registered under the Veterinary Surgeons Act *;

   "Registrar" means the Registrar of the Board appointed under section 6;

   "sale by way of wholesale" means sale to a person who buys for the purpose of selling again;

   "sell" with its grammatical variations and cognate expressions includes an agreement to sell and an offer to sell or any other act by which willingness to enter into any transaction of sale is expressed and an offer to sell shall be deemed to include the exposing of goods for sale;

   "substance" includes a preparation;

   "substance recommended as medicine", in relation to the sale of an article consisting of or comprising a substance so recommended, means a substance which is referred to–

   (i)   on the article or any wrapper or container in which the article is sold, or any label affixed to or in any document enclosed in, the article or that wrapper or container; or

   (ii)   in any placard or other document exhibited at the place where the article is sold; or

   (iii)   in any advertisement published by or on behalf of the manufacturer of the article, or the person carrying on the business in the course of which the article was sold, or, in the case where the article was sold, under a proprietary designation, the proprietor of the designation,

in terms which are calculated to lead to the use of the substance for the prevention or treatment of any ailment, infirmity or injury affecting human beings or animals, not being terms which give a definite indication that substance is intended to be used as, or as part of, a food or drink and not as, or as part of a medicine.

   (2) In this Act reference to sale of an article includes reference to the supply of an article as a sample for the purpose of inducing persons to buy by retail the substance of which the article consists or which it comprises.

PART II
PHARMACY (ss 3-19)

The Pharmacy Board and Registration of Pharmacists (ss 3-14)

3.   Establishment of Board

   (1) There is hereby established a Board to be known as the Pharmacy Board which shall, subject to this Act, be responsible for regulating the standards of conduct and activities of pharmacists and for the control of all dealings in pharmaceutical and in poisons.

   (2) The First Schedule to this Act shall have effect as to the constitution and proceedings of the Board and otherwise in relation to it.

   (3) The Minister may, by order in the Gazette, amend, vary or replace all or any of the provisions of the First Schedule to this Act.

4.   Functions of Board

   Subject to this Act, the functions of the Board shall be–

   (a)   to consider and decide upon applications for registration of pharmacists;

   (b)   to keep and maintain a register for the registration of pharmacists in accordance with this Act;

   (c)   to regulate the standards of conduct and activities of pharmacists and the practice of the profession of pharmacy;

   (d)   to promote interest in, and the advancement of, the profession of pharmacy;

   (e)   to provide opportunities or facilities for the study of and training in pharmacy, and to promote the development of research and the application of technical information relating to pharmacy;

   (f)   to evaluate academic and practical qualifications for the purposes of registration of pharmacists under this Act;

   (g)   to foster co-operation among pharmacists and between the Board and other institutions or organisations, whether or not concerned with the profession of pharmacy;

   (h)   to regulate, in accordance with this Act, the manufacture, importation, labelling, marking or identification, storage and sale of pharmaceutical or any substances used in the manufacture of pharmaceutical;

   (i)   to prescribe minimum standards of quality in respect of pharmaceutical manufactured or imported in or into the United Republic;

   (j)   to assist members of the public in matters touching upon, ancillary or incidental or conducive to the practice of the profession of pharmacy;

   (k)   to carry out such other functions as may be conferred upon the Board by any written laws or as are incidental to the performance of its functions under this Act.

5.   Power of Board to cancel or suspend registration

   (1) Subject to subsection (2), the Board may, after due inquiry and upon such grounds as may be prescribed by regulations made under section 71, cancel or suspend any registration made or any licence given under this Act.

   (2) In every inquiry conducted under this section the Board shall give the pharmacist, or other person, concerned a reasonable opportunity to answer allegations made against him.

6.   Appointment and functions of Registrar

   (1) The Minister shall appoint a public officer to be the Registrar of the Board, who shall also be Secretary to the Board.

   (2) The Registrar shall perform the duties prescribed in relation to his office under this Act and shall perform such other functions as the Minister or the Board may specify from time to time.

7.   Register of pharmacists

   (1) The Registrar shall keep a register of pharmacists in the prescribed form.

   (2) As soon as practicable after the Board has accepted any person for registration as a pharmacist, the Registrar shall enter in the register in respect of that person the following particulars–

   (a)   his name and address;

   (b)   the date of registration;

   (c)   his qualifications and the status of his registration; and

   (d)   such other particulars as the Board may, from time to time, direct.

   (3) All changes in the particulars registered under subsection (2) shall be entered in the register by the Registrar.

   (4) The Registrar may, with the general or specific approval of the Board rectify any clerical errors in the register or other document containing extracts from the register.

8.   Qualifications for registration

   (1) Subject to any regulations made under section 71 providing for the suspension or cancellation of any licence issued or registration granted under this Act, a person shall be entitled, on making an application to the Board in the prescribed manner, to be registered under this section and to offer his services for profit or gain if he is–

   (a)   immediately prior to the commencement of this Act, already registered as a pharmacist under section 8 of the Pharmacy and Poisons Ordinance *; or

   (b)   the holder of a pharmaceutical diploma recognised by the Board as furnishing a sufficient guarantee that he has the requisite academic knowledge of, skill and practical experience in, pharmacy; or

   (c)   a person who has, after obtaining a pharmaceutical diploma, complied with such additional requirements relating to the acquisition of practical experience as the Minister may, after consultation with the Board, prescribe by regulations made under section 71.

   (2) The Board may require an applicant for registration under this section to satisfy it that his professional and general conduct render him a fit and proper person to be registered.

9.   Provisional registration

   (1) Subject to any regulations made under section 71 providing for the suspension or cancellation of any licence issued or registration granted under this Act, any person who is not entitled to be registered by reason only of the fact that he has not complied with the additional requirements referred to in section 8(1)(c) shall, if, upon application in the prescribed manner, he satisfies the Board that he has secured an offer for employment or training in the public service or by a person or persons approved by the Board for the purposes of complying with the additional requirements, be entitled to be registered under this section.

   (2) A person registered under this section shall be deemed to be registered as far as is necessary to enable him to be employed or trained for the purposes stated in subsection (1) and while so employed or being trained, but not otherwise, may carry out the duties and responsibilities, exercise the rights and enjoy the privileges of a pharmacist.

   (3) The registration of a person under this section shall cease to have effect upon his being registered under section 8.

10.   Temporary registration

   (1) Where a person satisfies the Board–

   (a)   that he is not ordinarily resident in Mainland Tanzania;

   (b)   that he is or intends to be employed in Mainland Tanzania in the capacity of a pharmacist for the express purpose of carrying out a specific assignment for which he has been engaged; and

   (c)   that he is, or immediately before entering Mainland Tanzania was, in practice as a pharmacist and that he is eligible for registration under section 8,

the Board may, if it is satisfied that his professional and general conduct renders him a fit and proper person to be registered, direct that he be registered under this section for the duration of the specific assignment or for the period which the Board may specify.

   (2) The Board may require an applicant for registration under this section to appear before it or produce documents relating to his work or employment.

   (3) Registration of a person under this section shall continue only while he is engaged on the specific assignment or for the period specified by the Board and on his ceasing to be so engaged or on the expiry of the period, his registration shall cease to have effect. In case of doubt as to the cessation of his engagement on the specific assignment or as to the expiry of the period specified by the Board, the decision of the Board on the matter shall be final.

   (4) A pharmacist registered under this section shall, in relation to the duration of the specific assignment or the period specified by the Board and to things done in the course of that assignment, be treated as registered under section 8, but in relation to other things shall be treated as not so registered.

11.   Certificate of registration

   (1) Subject to subsection (2), upon the registration of a pharmacist and on payment of the prescribed fee, the Registrar shall issue a certificate of registration in the prescribed form.

   (2) No fee shall be payable in respect of a certificate of registration if the pharmacist was, on the appointed day, already registered under the Pharmacy and Poisons Ordinance *.

12.   Publication of registered particulars and lists of pharmacists

   (1) The Registrar shall cause to be published in the Gazette, as soon as may be practicable after registration, the particulars entered in the register in respect of each pharmacist and, subject to the directions of the Board, may cause to be so published any amendment or deletion of the particulars in the register.

   (2) The Registrar shall cause to be published in the Gazette, at least once each year, a list containing the particulars entered in the register in respect of all pharmacists remaining on the register at the close of the previous year.

13.   Publication sufficient evidence of registration

   (1) A publication under section 12 shall be sufficient evidence that the persons mentioned in it are registered under this Act, and the deletion from the register of the name of any person notified by the publication, or the absence of the name of any person from that publication, shall be sufficient evidence that, that person is not registered or that the validity of his registration has ceased to have effect.

   (2) The register, lists and all their copies or extracts from them which purport to have been certified under the hand of the Registrar shall be receivable in all courts and tribunals or other bodies authorised to receive evidence as sufficient evidence of the facts stated in them.

14.   Registrar may call for information

   The Registrar shall, if instructed by the Board, and may, if he considers it necessary for the furtherance of the objects and purposes of this Act, require any pharmacist or other person, by a registered letter sent to the last known address of the pharmacist or the other person, to furnish any information relating to his practice or business as a pharmacist or any other matter, which may be specified in the letter.

Restriction on Activities of Pharmacists (ss 15-19)

15.   Restriction on use of certain titles

   (1) Subject to section 16, no person other than a pharmacist shall, on or after the appointed day–

   (a)   carry on, either alone or in association with other persons, the business of a pharmacist;

   (b)   in the course of any trade or business, manufacture, or dispense any drug except under the immediate supervision of a pharmacist; or

   (c)   assume, take, exhibit, or in any way make use of any title, emblem, or description reasonably calculated to suggest that he is a pharmacist.

   (2) Any person who contravenes this section commits an offence and on conviction is liable to a fine not exceeding five thousand shillings or to imprisonment for a term not exceeding two years, or to both.

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