TZ Pharmaceutical and Poisons Act - VERTIC: Building … Legislation/Tanzania/TZ... · Control of recruitment and activities of medical representatives. ... Drugs used in local systems

THE PHARMACEUTICALS AND POISONS ACT, 1978

ARRANGEMENT OF SECTIONS

PART I

PRELIMINARY

S ection Title

1. Short title and commencement.

2. Inte rpre ta tion.

PART II

PHARMACY

The Pharmacy Board and Regis tration of Pharmacis ts

3. Es tablishment of Board.

4. Functions of Board.

5. Power of Board to cance l or suspend regis tra tion, e tc.

6. Appointment and functions of Regis tra r.

7. Regis te r of Pharmacis ts .

8. Qualifica tions for regis tra tion.

9. Provis iona l Regis tra tion.

10. Temporary Regis tra tion.

11. Certifica te of regis tra tion.

12. Publica tion of regis te red particula rs and lis ts of pharmacis ts .

13. Publica tion sufficient evidence of regis tra tion.

14. Regis tra r may ca ll for information.

Res triction on Activities of Pharmacis ts

15. Res triction on use of ce rta in titles , e tc.

16. Bodies of persons opera ting as pharmacis ts .

17. Definition of ''ca rrying on bus iness '' or ''practis ing''a s pharmacis t.

18. Res triction on directions by Board.

19. Control of recruitment and activities of medica l representa tives .

PART III

LICENSING OF MANUFACTURERS

20. Res triction of manufacture of pharmaceutica ls .

21. Regis te r of manufacture rs of pharmaceutica ls .

22. Applica tion for and grant of licence to manufacture pharmaceutica ls .

1

2 Pharmaceuticals and Poisons 1978No. 9

Regis tration of Premises

23. Regis tra tion of premises for manufacture of pharmaceutica ls and for otherbus iness of pharmacis ts .

24. Applica tion for regis tra tion.

PART IV

COMPOSITIONS OF PHARMACEUTICALS

25. Regula tions regarding the compos ition of pharmaceutica ls .26. Prohibition of prepara tion and sa le of adulte ra ted pharmaceutica ls .27. Genera l protection for purchasers of pharmaceutica ls .

Pharmaceuticals Unfit for Use by Man

28. Offences regarding sa le , e tc. of pharmaceutica ls unfit for use by man.29. Pharmaceutica ls offe red as prizes , e tc.

Importation of Pharmaceuticals

30. Res triction on importa tion of pharmaceutica ls , e tc.31. Applica tion and conditions for regis tra tion.32. Publica tion of regis te red particula rs of importe rs of pharmaceutica ls .

Poisons

33. Lis t of poisons for purposes of Act.

34. Conditions for pharmacis t to become authorized se lle r of poisons .

35. Conditions for body corpora te to become authorized se lle r of poisons .

36. Lis t of shops and pharmacis ts in charge .

37. Possess ion of Part I poisons prohibited in certa in cases .

38. Wholesa le dea le r's licence .

39. Licence to dea l in poisons for mining, agricultura l or horticultura lpurposes .

40. Power to se ll Part I Poisons .

41. Poisons Book.

42. Supply and dispens ing of Part I poisons by doctors , hospita ls , e tc.

43. Licence to se ll Part II poisons .

44. Power to se ll Part II poisons .

45. Poisons not to be sold in automatic machines .

46. Disposa l of s tocks by disentitled persons .

Labeling and Advertisement

47. Labe ling of conta iners .48. Labe ling of a rticles conta ining medicine .49. Prohibition of advertisements as to certa in diseases , e tc.50. Prohibition of advertisements as to abortion.51. Fa lse labe ling and advertisement.

31978Pharmaceuticals and PoisonsNo. 9

PART V

ENFORCEMENT AND LEGAL PROCEEDINGS

S ampling and Analys is

52. Power to take samples .53. Right to have sample ana lysed.54. Provis ions regarding the taking of samples for ana lys is .55. Where divis ion of sample into parts impracticable .

Enforcement

56. Appointment of inspectors .

57. Power of inspectors .

58. Power to prohibit or control ce rta in medicines . e tc.

Legal Proceedings

59. Certifica te of ana lys is .

60. Evidence of ana lys is .

61. Presumptions .

62. Where warranty may be pleaded as defence .

63. Offences in re la tion to warranties or ce rtifica tes of ana lys is .

64. Recovery of expenses incidenta l to taking of samples .

65. Forfe iture .

66. Appea ls .

67. Right to carry on bus iness pending appea l.

PART VI

MISCELLANEOUS PROVISIONS

68. Drugs used in loca l sys tems of therapeutics .

69. Liability of members of Board, e tc.

70. Power to de lega te .

71. Regula tions .

72. By-laws by Board.

PART VII

REPEALS AND CONSEQUENTIAL PROVISIONS

73. Repea l of Cap. 93 and Cap. 416.

74. Savings .

75. Trans itiona l provis ions .

Pharmaceuticals and Poisons 51978No. 9

THE UNITED REPUBLIC OF TANZANIA

No. 9 OF 1978

An Act to repeal the Pharmacy and Poisons , Ordinance , and theprovis ions of the Food and Drugs Ordinance re lating to drugs; toprovide for the control of the profess ion of Pharmacy, and ofmatters re lating to dealings in pharmaceuticals and poisons

][ENACTED by the Parliament of the United Republic of Tanzania .

PART I

PRELIMINARY

1. This Act may be cited as the Pharmaceutica ls and Poisons Act, 1978,and sha ll come into opera tion on such da te as the Minis te r may, by noticein the Gazette , appoint.

2.-(1) In this Act, unless the context otherwise requires -

"advertisement'' includes any notice , circula r, labe l, wrapper or other docu-ment, and any announcement made ora lly or by means of producing ortransmitting light or sound:

''the appointed day'' means the da te appointed by the Minis te r in the Gazetteas the day when this Act sha ll come into opera tion;

"authorized se lle r of poisons '' means any of the persons decla red by sections34 and 35 to be authorized se lle rs of poisons ;

''the Board'' means the Pharmacy Board es tablished by section 3;

''British Pharmaceutica l Codex'' and ''British Vete rinary Codex'' mean,respective ly, the current edition, and any amendments made to them, of thebooks published by these names by the Pharmaceutica l Socie ty of Grea tBrita in;

''British Pharmacopoeia '' means the current edition, and any amendmentsmade to it from time to time , of the book published by tha t name in pursu.ance of section 47 of the Medica l Act, 1956, of the United Kingdom orany enactment replacing it;

''ce rtifica te of regis tra tion'' means the certifica te is sued to a pharmacis t under

section 11 upon his be ing regis te red by the Board;

....MAY, 197819TH

Short title

and

commence-

ment

Inte rpre ta -

tion

4 and 5

Eliz, 2

c. 76


''dispense '' in re la tion to a medicine , pharmaceutica l product or poison meansto supply a medicine , pharmaceutica l product or poison on and in accor-dance with a prescription lawfully given by a qua lified medica l practitioner,dentis t or ve te rinary surgeon;

''drug'' includes any medicine , medicina l prepara tion or therapeutic subs tance ;

''for use by man'' means for human consumption or for exte rna l applica tionto the human body;

''Government Analys t'' means the Government Chemis t and any ana lys tappointed by the Minis te r for the purposes of this Act;

''Inte rna tiona l Pharmacopoeia '' means the current edition, and any amend-ments made to it from time to time , of the book published by tha t nameby the World Hea lth Organiza tion;

''labe lled'' means dis tinctly labe lled in English or La tin and in Kiswahili;

''manufacture '', with its grammatica l varia tions and cogna te express ions , meansto subject any phys ica l a rticle or subs tance commonly used to preparedrugs or other pharmaceutica l products , to any process , including prepa-ra tion and compounding, which results in tha t a rticle or subs tance be ingposs ible of use by man as a pharmaceutica l product or poison, whetheror not on a lawfully given prescription;

"medicine '' means any medicament or cura tive or preventive subs tancewhether proprie ta ry or in the form of a prepara tion;

"member'' in re la tion to the Board means a member of the Pharmacy Boardand includes the Chairman and the Vice-Chairman;

"Minis te r'' means the Minis te r for the time be ing respons ible for matte rsre la ting to hea lth and medica l se rvices ;

-Pharmaceutica l" and ''pharmaceutica l product'' means any drug, subs tanceor other a rticle manufactured or prepared in any way and intended for useby man as a medicine or as a remedy used for the purposes of medica l,denta l or ve te rinary trea tment;

"pharmacis t'' means a pharmaceutica l chemis t or a chemis t and druggis twho is regis te red under this Act;

"poison'' means a pharmaceutica l product included in the Poisons lis t re fe rredto in section 33;

"qua lified'' in re la tion to a medica l practitioner, dentis t or ve te rinary surgeon,as the case may be , means a medica l practitioner or dentis t regis te red underthe Medica l Practitioners and Dentis ts Ordinance and a Vete rinary Sur-geon regis te red under the Vete rinary Surgeons Ordinance ;

Cap. 409Cap. 376

''Regis tra r'' means the Regis tra r of the Board appointed under section 6;

"se ll" with its grammatica l varia tions and cogna te express ions includes anagreement to se ll and an offe r to se ll or any other act by which willingnessto ente r into any transaction of sa le is expressed and an offe r to se ll sha llbe deemed to include the expos ing of goods for sa le ;

"'sa le by way of wholesa le '' means sa le to a person who buys for the purposeof se lling aga in;

"subs tance" includes a prepara tion;


''subs tance recommended as medicine '', in re la tion to the sa le of an a rticlecons is ting of or compris ing a subs tance so recommended, means a subs tancewhich is re fe rred to-

(i) on the a rticle or any wrapper or conta iner in which the a rticle is sold,or any labe l a ffixed to or in any document enclosed in, the a rticle ortha t wrapper or conta iner; or

(ii) in any placard or other document exhibited a t the place where the a rticleis sold; or

(iii) in any advertisement published by or on beha lf of the manufacture r ofthe a rticle , or the person carrying on the bus iness in the course of whichthe a rticle was sold, or, in the case where the a rticle was sold, undera proprie ta ry des igna tion, the proprie tor of the des igna tion,

in te rms which a re ca lcula ted to lead to the use of the subs tance for the preven-tion or trea tment of any a ilment, infirmity or injury a ffecting human be ingsor animals , not be ing te rms which give a definite indica tion tha t the subs tanceis intended to be used as , or as part of, a food or drink, and not as , or as partof a medicine .

(2) In this Act re fe rence to sa le of an a rticle includes re fe rence to thesupply of an a rticle as a sample for the purpose of inducing persons to buyby re ta il the subs tance of which the a rticle cons is ts or which it comprises .

PART II

THE PHARMACY BOARD AND REGISTRATION OF PHARMACISTS

3.-(1) There is hereby es tablished a Board to be known as the Pharmacy Boardwhich sha ll, subject to this Act, be respons ible for regula ting the s tandards ofconduct and activities of pharmacis ts and for the control of a ll dea lings in phar-maceutica ls and in Poisons .

(2) The Firs t Schedule to this Act sha ll have e ffect as to the cons titution andproceedings of the Board and otherwise in re la tion to it.

(3) The Minis te r May, by order in the Gazette , amend, vary or replace a ll orany of the provis ions of the Firs t Schedule to this Act.

4. Subject to this Act, the functions of the Board sha ll be-(a ) to cons ider and decide upon applica tions for regis tra tion of pharmacis ts ;

Functionsof Board

(b) to keep and mainta in a regis te r for the regis tra tion of pharmacis t inaccordance with this Act;

(c) to regula te the s tandards of conduct and activities of pharmacis ts and thepractice of the profess ion of Pharmacy;

(d) to promote inte res t in, and the advancement of, the profess ion ofPharmacy;

(e ) to provide opportunities or facilities for the s tudy of andtra ining in pharmacy, and to promote the deve lopment of research andthe applica tion of technica l information re la ting to pharmacy;

(f) to eva lua te academic and practica l qua lifica tions for the purposes ofregis tra tion of pharmacis ts under this Act;

(g) to fos te r co-opera tion among pharmacis ts and be tween the Board andother ins titutions or organiza tions , whether or not concerned with theprofess ion of pharmacy;

Establish-

ment of

Board


(h) to regula te , in accordance with this Act, the manufacture importa tionlabe lling, marking or identifica tion, s torage and sa le of pharmaceutica lsor any subs tances used in the manufacture of pharmaceutica ls ;

(i) to prescribe minimum s tandards of qua lity in respect of Pharmaceutica lsmanufactured or imported in or into the United Republic;

(j) to ass is t members of the public in matte rs touching upon, ancilla ry orincidenta l or conducive to the practice of the profess ion of pharmacy;

(k) to carry out such other functions as may be conferred upon the Board byany written law or as a re incidenta l to the performance of its functionsunder this Act.

Power of 5.-(1) Subject to subsection (2), the Board May, a fte r due inquiry and uponsuch grounds as may be prescribed by regula tions made under section 71, cance lor suspend any regis tra tion made or any licence given under this Act.

Board tocance l orsuspendregis tra tion. (2) In every inquiry conducted under this section the Board sha ll give the

pharmacis t, or other person, concerned a reasonable opportunity to answera llega tions made aga ins t him.

e tc.

Appointment 6.-(l) The Minis te r sha ll appoint a public office r to be the Regis tra r of theBoard, who sha ll a lso be Secre ta ry to the Board.and

functions(2) The Regis tra r sha ll perform the duties prescribed in re la tion to his office

under this Act and sha ll Perform such other functions as the Minis te r or the Boardmay specify from time to time-

of Regis tra r

Regis te r of 7.-(1) The Regis tra r sha ll keep a regis te r of pharmacis ts in the prescribed formpharmacis ts

(2) As soon as practicable a fte r the Board has accepted any person for regis tra -tion as a pharmacis t, the Regis tra r sha ll ente r in the regis te r in respect of tha tperson the following particula rs :-

(a ) his name and address ;

(b) the da te of regis tra tion;(c) his qua lifica tions and the s ta tus of his regis tra tion; and(d) such other particula rs as the Board may, from time to time , direct.

(3) All changes in the particula rs regis te red under subsection (2) sha ll beente red in the regis te r by the Regis tra r.

(4) The Regis tra r may, with the genera l or specific approva l of the Board,rectify any cle rica l e rrors in the regis te r or other document conta ining extractsfrom the regis te r.

Qualifica - 8.-(1) Subject to any regula tions made under section 71 providing fortions for the suspens ion or cance lla tion of any licence issued or regis tra tion granted underregis tra tion this Act, a Person sha ll be entitled, on making an applica tion to the Board in

the prescribed manner, to be regis te red under this section and to offe r his se rvicesfor profit or ga in if he is -

(a ) immedia te ly prior to the commencement of this Act, a lready regis te red asa pharmacis t under section 8 of the Pharmacy and Poisons Ordinance ; or

Cap. 416(b) the holder of a pharmaceutica l diploma recognized by the Board as furni-

shing a sufficient guarantee tha t he has the requis ite academic knowledgeof, skill and practica l experience in, pharmacy; or

(c) a person who has , a fte r obta ining a pharmaceutica l diploma, compliedwith such additiona l requirements re la ting to the acquis ition of practica lexperience as the Minis te r may, a fte r consulta tion with the Board, prescribeby regula tions made under section 71.

1978Pharmaceuticals and PoisonsNo. 9 9

(2) The Board may require an applicant for regis tra tion under this section tosa tis fy it tha t his profess iona l and genera l conduct render him a fit and properperson to be regis te red.9.-(1) Subject to any regula tions made under section 71 providing for thesuspens ion or cance lla tion of any licence issued or regis tra tion granted underthis Act, any person who is not entitled to be regis te red by reason only of thefact tha t he has not complied with the additiona l requirements re fe rred to insection 80) (c) sha ll, if, upon applica tion in the prescribed manner, he sa tis fies theBoard tha t he has secured an offe r for employment or tra ining in the publicservice or by a person or persons approved by the Board for the purposes ofcomplying with the additiona l requirements , be entitled to be regis te red under thissection.

(2) A person regis te red under this section sha ll be deemed to be regis te red asfa r as is necessary to enable him to be employed or tra ined for the purposess ta ted in subsection (1) and while so employed or be ing tra ined, but not other-wise , may carry out the duties and respons ibilities , exercise the rights and enjoythe privileges of a pharmacis t.

(3) The regis tra tion of a person under this section sha ll cease to have e ffectupon his be ing regis te red under section 8.

10.-(1) Where a person sa tis fies the Board-Temporaryregis tra tion(a ) tha t he is not ordinarily res ident in Tanganyika ;

(b) tha t he is or intends to be employed in Tanganyika in the capacity of a .pharmacis t for the express purpose of ca rrying out a specific ass ignmentfor which he has been engaged; and

(c) tha t he is , or immedia te ly before ente ring Tanganyika was , in practice asa pharmacis t and tha t he is e ligible for regis tra tion under section 8,

the Board may, if it is sa tis fied tha t his profess iona l and genera l conduct rendershim a fit and proper person to be regis te red, direct tha t he be regis te red underthis section for the dura tion of the specific ass ignment or for the period whichthe Board may specify.

(2) The Board may require an applicant for regis tra tion under this sectionto appear before it or produce documents re la ting to his work or employment.

(3) Regis tra tion of a person under this section sha ll continue only while he isengaged on the specific ass ignment or for the period specified by the Board andon his ceas ing to be so engaged or on the expiry of the period, his regis tra tionsha ll cease to have e ffect. In case of doubt as to the cessa tion of his engagementon the specific ass ignment or as to the expiry of the period specified by the Board,the decis ion of the Board on the matte r sha ll be fina l.

(4) A pharmacis t regis te red under this section sha ll, in re la tion to the dura tionof the specific ass ignment or the period specified by the Board, and to thingsdone in the course of tha t ass ignment, be trea ted as regis te red under section 8,but in re la tion to other things sha ll be trea ted as not so regis te red.

11.-(l) Subject to subsection (2), upon the regis tra tion of a pharmacis t and onpayment of the prescribed fee , the Regis tra r sha ll is sue a ce rtifica te of regis tra tionin the prescribed form.

(2) No fee sha ll be payable in respect of a ce rtifica te of regis tra tion if thepharmacis t was , on the appointed day, a lready regis te red under the Pharmacyand Poisons Ordinance .

12.-(1) The Regis tra r sha ll cause to be published in the Gazette , as soon asmay be practicable a fte r regis tra tion, the particula rs ente red in the regis te r in ofrespect of each pharmacis t and, subject to the directions of the Board, may causeto be so published any amendment or de le tion of the particula rs in the regis te r.

Provis iona l

regis tra tion

Certifica te

of regis tra -

tion

Cap. 416

Publica tion

of regis te red

particula rs

and lis ts of

pharmacis ts


(2) The Regis tra r sha ll cause to be published in the Gazette , a t leas t onceeach year, a lis t conta ining the particula rs ente red in the regis te r in respect of a llpharmacis ts remaining on the regis te r a t the close of the Previous Year-

13.-(1) A publica tion under section 12 sha ll be sufficient evidence tha t thepublica tionsufficient persons mentioned in it a re regis te red under this Act, and the de le tion from theevidence of regis te r of the name of any person notified by the publica tion, or the absence ofregis tra tion t he name of any person from tha t publica tion, sha ll be sufficient evidence tha t

tha t person is not regis te red or tha t the va lidity Of his regis tra tion has ceased tohave e ffect.

(2) The regis te r, lis ts and a ll the ir copies or extracts from them which purportto have been certified under the hand of the Regis tra r sha ll be rece ivable in a llcourts and tribuna ls or other bodies authorized to rece ive evidence as sufficientevidence of the facts s ta ted in them.

14.-The Regis tra r sha ll, if ins tructed by the Board, and may, if he cons iders itRegis tra r

may ca ll for necessary for the furtherance of the objects and purposes of this Act, require anyinformation pharmacis t or other person, by a regis te red le tte r sent to the las t known address

of the pharmacis t or the other person, to furnish any information re la ting to hispractice or bus iness as a pharmacis t or any other matte r, which may be specifiedin the le tte r.

Res triction on Activities of Pharmacis ts

Restriction 15.-(1) Subject to section 16, no person other than a pharmacis t sha ll, on ora fte r the appointed day-on use of

certa intitles . e tc. (a ) ca rry on, e ither a lone or in associa tion with other persons , the bus iness of

a pharmacis t;

(b) in the course of any trade or bus iness , manufacture , or dispense any drugexcept under the immedia te supervis ion of a pharmacis t.

(c) assume, take exhibit or in any way make use of any title , emblem, ordescription reasonably ca lcula ted to sugges t tha t he is a pharmacis t.

(2) Any person who contravenes this section sha ll be guilty of an offence andsha ll be liable on conviction to a fine not exceeding five thousand shillings or toimprisonment for a te rm not exceeding two years , or to both tha t fine andimprisonment.

(3) For the purpose of subsection I(c), the use of any of the titles ''pharmacis t'',''druggis t'', "Chemis t" , "Pharmaceutis t" or -pharmaceutica l chemis t'', or anys imila r word or combina tion of words in any language , sha ll be deemed to bereasonably ca lcula ted to sugges t tha t the owner of the bus iness and the personhaving control of the bus iness on the premises a re pharmacis ts .

(4) Nothing in this section sha ll extend to or inte rfe re with the supply ofmedicine to a particula r person by a qua lified medica l practitioner, dentis t orve te rinary surgeon for the purpose of medica l, denta l or ve te rinary trea tment.

(5) Nothing in this section sha ll be deemed to make it unlawful for any personto se ll any non-poisonous drug provided tha t the drug is sold in its origina lcondition as rece ived by the se lle r, or to require tha t person to be regis te red as apharmacis t.

16.-(1) No body of persons whether corpora te or unincorpora ted sha ll ca rry onbus iness or practice as pharmacis ts except in accordance with this section.

Bodies ofpersonsopera ting aspharmacis ts

Pharmaceuticals and PoisonsNo. 9 1978 11

(2) Where the body is a body corpora te -

(a ) a copy of the certifica te of its incorpora tion sha ll be lodged with the Board;

(b) the bus iness sha ll be under the management of a superintendent who isa pharmacis t and a lso a member of its board of directors who is notacting in a s imila r capacity for any other body corpora te ;

(c) in each se t of premises for the re ta il sa le of pharmaceutica ls , the bus inesssha ll be carried on by the superintendent or by a manager or ass is tantwho is a pharmacis t and who is subject to the directions of the superin-tendent;

(d) the name and certifica te of regis tra tion of the person in control of theshop or wholesa le bus iness sha ll be conspicuous ly displayed in eachse t of premises where the bus iness is ca rried on.

(3) Where the body is a partnership-

(a ) a copy of the certifica te of its regis tra tion under the Bus iness Names(Regis tra tion) Ordinance , if any, sha ll be lodged with the Board; Cap. 213

(b) one or more of the partners sha ll be a pharmacis t;

(c) it sha ll comply with the provis ions of subsection (2) (c) and (d).

(4) Where a superintendent, a partner or member of a body of persons ,whether corpora te or unincorpora ted carrying on bus iness or practis ing aspharmacis ts dies , the body of persons may, notwiths tanding the provis ions ofsubsections (1), (2) and (3), continue to carry on bus iness or practise until suchtime as the adminis tra tion of the es ta te of the deceased is comple ted, as if suchlega l representa tives were pharmacis ts .

(5) Nothing m this Act sha ll be cons trued as entitling any body of persons ,whether corpora te or unincorpora ted, to be regis te red as pharmacis ts .

(6) Any body of persons which carries on bus iness or practises as pharmacis tsin contravention of this section sha ll be guilty of an offence and sha ll be liableon conviction to a fine not exceeding thirty thousand shillings .

17. For the purposes of this Act, a person sha ll be deemed to be carrying onbus iness or practis ing as a pharmacis t if, for a fee , reward or other va luablecons idera tion, he offe rs or renders the se rvices ordinarily offe red or renderedby persons recognized as skilled in the science and a rt of preserving pharmaceu-tica ls and of compounding and dispens ing medicines according to prescriptions

18.-(1) Where an act or omiss ion which, under this Part, may be made theground of a direction by the Board involving the cesser or res triction of theright of a person to have his name regis te red, is an act or omiss ion on the partof an employee of tha t person, the Board sha ll not give any such directionunless proof is given to its sa tis faction of some one or more of the facts specifiedin subsection (2) and the Board is of the opinion tha t, having regard to the ,facts so proved, tha t person ought to be regarded as respons ible for the actor omiss ion.

(2) The facts some one or more of which the Board mus t be sa tis fied beforegiving the direction re fe rred to in subsection (1) a re :-

(a ) tha t the act or omiss ion in ques tion was ins tiga ted or connived a t by tha tperson;

Definition of

"carrying"

on bus iness"

or

"practis ing"

by Board

Regis tra tion

on directions

by Board


(b) tha t person or his employee had been guilty, within twelve monthsimmedia te ly preceding the da te when the act or omiss ion concernedoccurred, of a s imila r act or omiss ion and tha t person had,or reasonably ought to have had, knowledge of tha t previous act oromiss ion;

(c) if the act or omiss ion concerned was a continuing act or omiss ion, tha tthe sa id person had, or reasonably ought to have had, knowledge of itscontinuance ;

(d) in the case of a crimina l offence which is an offence under this Act, tha tthe person had not exercised due diligence to enforce the execution ofthe Act.

(3) in this section re fe rences to the respons ibility, knowledge or diligenceof the owner of the bus iness sha ll, if the owner is a body corpora te , be cons truedas re fe rences to the respons ibility, knowledge or diligence of tha t body as awhole .

19.-(1) The Minis te r may, a fte r consulta tion with the Board, by order in the

Gazette , provide for the regula tion of the recruitment and the activities of medica l preventa tives .

(2) The Minis te r may, by an order made under subsection (1), provide forthe licens ing, regis tra tion and payment of fees on applica tion, and may requiretha t persons who may be recruited as medica l representa tives by any person sha llbe persons who have a tta ined a s tandard of academic educa tion and a measureof practica l knowledge of pharmacy, which the Minis te r. on the recommenda-tion of the Board, may specify.

PART III

MANUFACTURE OF PHARMACEUTICALS

Licens ing of Manufacturers

20.-(1) No person sha ll, on or a fte r the appointed day, manufacturepharmaceutica ls unless he is the holder of a licence issued by the Board undersection 22 for tha t purpose .

Restrictionon manu-facture ofpharmaceu-tica ls (2) Any person who contravenes or fa ils to comply with subsection (1) sha ll

be guilty of an offence and sha ll be liable on conviction to a fine not exceedingtwenty thousand shillings or to imprisonment for a te rm not exceeding fiveyears or to both tha t fine and imprisonment.

Regis te r of 21. As soon as practicable a fte r the Board has accepted an applica tion by amanu- person for a licence to manufacture pharmaceutica ls , the Regis tra r sha ll ente rfacture rs of in a regis te r in re la tion to tha t person such particula rs as the Board may, fromPharmaceu- time to time , direct.tica ls

22.-(1) Subject to subsection (2), an applica tion for a licence to manufacturepharmaceutica ls sha ll be made to the Board in the prescribed manner.

Applica tionfor andgrant oflicence to (2) A person sha ll be granted a licence to manufacture pharmaceutica ls , if,

a fte r sa tis fying the Board as to his fulfillment of such requirements as the Minis te rmanufa-

cturepharmaccu- may prescribe by regula tions made under section 71, he pays the prescribed fee .tica ls

Control of

recruitment

and activities

of medica l

representa -

tives


Regis tration of Premises

23.-(1) No person sha ll manufacture pharmaceutica ls or ca rry on bus inessor practise as a pharmacis t except in premises regis te red under this section.

(2) The Regis tra r sha ll keep a regis te r in the prescribed form of a ll premisesregis te red under this section.

(3) The Regis tra tion of any premises under this section sha ll cease to haveeffect upon the expira tion of thirty days from the da te of any change of the

ownership of the bus iness carried on in them.

(4) Any person who contravenes or fa ils to comply with this section sha ll beguilty of an offence and sha ll be liable on conviction to a fine not exceeding fivethousand shillings or to imprisonment for a te rm not exceeding twelve monthsor to both tha t fine and imprisonment.

24.-(l) Every applica tion for regis tra tion of premises sha ll be made to theBoard in the prescribed form, and sha ll be accompanied by such fee , notexceeding one hundred shillings , in respect of the regis tra tion of any se t ofpremises , as may be prescribed.

(2) The Board may, for good and sufficient reason to be s ta ted in writingrefuse to regis te r, or may cause to be de le ted from the regis te r, any premiseswhich a re or have become unsuitable for the manufacture in them ofpharmaceutica ls , or for the lawful ca rrying on in them of bus iness , or practiceas , a pharmacis t.

PART IV

DEALINGS IN PHARMACEUTICALS AND POISONS

Composition of Pharmaceuticals

25.-(1) The Minis te r may, a fte r consulta tion with the Board, make regu-la tions prescribing minimum s tandards to be complied with by manufacture rswith regard to the compos ition of pharmaceutica ls or the ir bacte riologica lor chemica l s tandard.

(2) Without pre judice to the genera lity of the power conferred by subsection(1), the Minis te r may in those regula tions-

(a ) require , prohibit or regula te the addition to pharmaceutica ls , or extrac-tion from them, of any specified subs tance or any subs tance of anyspecified ca tegory, or the use of any subs tance as an ingredient in themanufacture or preserva tion of any pharmaceutica ls or poisons ;

(b) prohibit, res trict or regula te the importa tion or manufacture , or thesa le , possess ion for sa le , or the cons ignment or de livery, of pharma-ceutica ls , or the ingredients of any pharmaceutica l product or products ,which do not comply with those regula tions ;

(c) prohibit or regula te the importa tion of any pharmaceutica l product orca tegory of pharmaceutica ls , which, m his opinion, is or may be pre ju-

dicia l to public hea lth;(d) prohibit, res trict or regula te the importa tion or the use of any specified

materia ls of any specified ca tegory, in the manufacture of appara tus orutens ils des igned for use in the prepara tion or preserva tion of phar-maceutica ls for use by man;

(e ) prescribe or provide for methods of ana lys is for the purpose of ascer-ta ining the presence in any pharmaceutica l product, or the absencefrom it, of any specified subs tance , or the quantity of any subs tance ,present in the drug.

Regis tra tion

of premises

for manufa-

cture of

pharmaceu-

tica ls and

for other

bus iness of

pharmacis ts

Applica tion

for

regis tra tion

Regula tions

regarding the

compos ition

of

pharmaceu-

tica ls

Pharmaceuticals and Poisons14 No. 9 1978

26.-(1) No Person sha ll add any subs tance to, or abs tract any cons tituentProhibition

on prepara- from, a pharmaceutica l product so as to a ffect injurious ly the qua lity, cons ti-tion andsa le ofadulte ra tedpharmaceu-tica ls

tution or potency of the product, with intent tha t pharmaceutica l productsha ll be sold in tha t s ta te .

(2) Subject to this section, no Person sha ll se ll, offe r, expose or advertisefor sa le , or have in his possess ion for the purpose of sa le , any pharmaceutica lproduct injurious ly a ffected in its qua lity, cons titution or potency by meansof any opera tion re ffe red to in subsection (1).

(3) Any person who contravenes or fa ils to comply with subsection (1) orsubsection (2) sha ll be guilty of an offence and sha ll be liable on convictionto a fine of not more than five thousand shillings or to imprisonment for ate rm not exceeding three years or to both tha t fine and imprisonment.

(4) in any proceedings for an offence under subsection (2) cons is ting ofthe advertisement for sa le of a pharmaceutica l product, it sha ll be a defencefor the defendant to prove tha t, be ing a person whose bus iness it is to publishor a rrange for the publica tion of advertisements , he rece ived the advertisementfor publica tion in the ordinary course of bus iness .

27.-(1) Any person who se lls to the pre judice of a purchaser any pharma-Genera lprotection ceutica l product which is not of the na ture , subs tance or qua lity of the Product

demanded by the purchaser sha ll be guilty of an offence .forpurchasersof (2) Where regula tions made under section 25 conta in provis ions prescrib-pharmaceu- ing the compos ition of or prohibiting or res tricting the addition of anyfica ls subs tance to, any pharmaceutica l product, a purchaser of tha t product

sha ll, unless the contra ry is proved, be deemed, for the Purpose of subsection(1), to have demanded a pharmaceutica l product complying with thoseprovis ions .

(3) In any proceedings for an offence under subsection (1), it sha ll not bea defence for the defendant to a llege tha t the purchaser bought for ana lys isor examina tion and there fore was not pre judiced.

Pharmaceuticals Unfit For Use by Man

28.-(1) Any person who-offencesregarding

(a ) se lls , or offe rs or exposes for sa le , or has in his possess ion for the pur-pose of sa le or manufacture for sa le ; or

sa le , e tc. ofpharmaceu-tica ls unfit

(b) depos its with, or cos igns to, any person for the purpose of sa le or ofmanufacture for sa le ,

for use byman

any pharmaceutica l product intended, but unfit, for use by man sha ll be guiltyof an offence .

(2) Where any pharmaceutica l product in respect of which an offence undersubsection (1) (a ) has been committed was sold to the defendant by someother person, tha t other person sha ll a lso be guilty of an offence ,

(3) Where a person is charged with an offence under subsection (1) (b),or under subsection (2), it sha ll be a defence for him to prove e ither-

(a ) tha t he gave notice to the person with whom he depos ited or to whomhe cons igned or sold, the pharmaceutica l product concerned tha t it was not inte -nded for use by man, or

(b) tha t a t the time when he de livered or dispa tched it to tha t person, e itherthe product was fit for use by man, or he did not know, and could not withreasonable diligence have known, tha t it was unfit.

Pharmaceuticals and PoisonsNo. 9 151978

29.-(1) Sections 28 and 58 sha ll apply in re la tion to-

(a ) any pharmaceutica l product intended for use by man, which is offe redas a prize or reward in connection with any ente rta inment to which thepublic a re admitted, whether or not on payment of money, as if the productwere , or had been, exposed for sa le by each person concerned in the organiza tionof the ente rta inment;

(b) any pharmaceutica l product intended for use by man which is offe redas a prize or reward or given away for the purpose of advertisement, or infurtherance of any trade or bus iness , as if the product were or hadbeen exposed for sa le by the person offe ring or giving it away;

(c) any pharmaceutica l product intended for use by man which is exposedor depos ited in any premises for the purpose of be ing so offe red or given away,as if the product were , or had been, exposed for sa le by the occupie r of thosepremises .

(2) in this section, the express ion ''ente rta inment'' includes any socia l ga the-ring, amusement, exhibition, performance , game, lotte ry or tria l of skill.

Importa tion of Pharmaceutica ls

30.-(1) No person sha ll, on or a fte r the appointed day, engage in the import-a tion of pharmaceutica ls , or of subs tances for the manufacture of pharma-ceutica ls , unless he is regis te red by the Board under this section.

(2) The Regis tra r sha ll keep a regis te r in the prescribed form in whichhe sha ll ente r and mainta in the following particula rs -

(a ) the name and address of every person regis te red for the purposes of thissection;

(h) the da te of regis tra tion;

(c) the names of the pharmaceutica l which he is permitted to import;

(d) the bacte riologica l e ffects and chemica l compos ition of the phar-maceutica ls in respect of which he has been regis te red as an importe r;

(e ) such other particula rs as the Minis te r may, from time to time , de te rmine .

(3) The provis ions of section 31 sha ll be complied with by every personregis te red under this section on every occas ion he proposes to import a pharma-ceutica l product or subs tance for the manufacture of pharmaceutica ls , whichwas not included in his origina l or, as the case may be , subsequent applica-tion for regis tra tion.

31.-(l) Every applica tion for regis tra tion under section 30 sha ll be addressed

to the Regis tra r and sha ll be in the prescribed form.

(2) Upon rece ipt of an applica tion for regis tra tion under section 30, the Boardsha ll, a s soon as may be practicable , proceed to cons ider the applica tion andgrant regis tra tion where it is due .

(3) The Minis te r may, by order in the Gazette , prescribe factors to whichthe Board sha ll have regard when cons idering applica tions for regis tra tion undersection 30.

32. The Regis tra r sha ll, a t leas t once in each year, publish in the Gazettethe particula rs in respect of every person regis te red under section 30.

Pharmeceu-

tica ls offe red

as prizes ,

e tc.

Res triction

on impota-

tion of

pharmaceu-

tica ls , e tc.

Applica tion

and

conditions

for regis tra -

tion

Publica tion

of regis te red

particula rs

of importe rs

of pharmace-

utica ls


Lis t of 33.-(1) The Board sha ll, with the consent of the Minis te r, by order in thepoisons for Gaze tte , decla re a lis t of subs tances which sha ll be trea ted as poisons for thepurposes purposes of this Act.of Act

(2) The lis t decla red sha ll be divided into the following two parts :-Part I of the lis t sha ll cons is t of poisons which, subject to this Act, sha ll not be

sold except by an authorized se lle r of poisons or a licensed wholesa le dea le rin mining, agricultura l or horticultura l accessories ;

Part H of the lis t sha ll cons is t of poisons which, subject to this Act, sha ll not besold except by a person entitled to se ll Part I poisons and by persons licensedunder section 43.

(3) In de te rmining the dis tribution of poisons as be tween the two Parts ofthe Lis t, regard sha ll be had to the des irability of res tricting Part 11 to a rticleswhich a re in common use , or like ly to come into common use , for purposesother than the trea tment of human a ilments and which it is reasonably necessaryto include in tha t Part 11 if the public a re to have adequa te facilities for obta in-ing them.

(4) The Board may, subject to any directions of the Minis te r given in tha tbeha lf, amend or vary the Lis t, from time to time , as it deems proper.

34. A pharmacis t ca rrying on bus iness compris ing the re ta il sa le of pharma-ceutica ls sha ll be an authorized se lle r of poisons within the meaning of this

Conditionsforpharmacis t Act if-to become

(a ) in each se t of premises for the re ta il sa le of drugs , the bus iness is ca rriedauthorizedon under the persona l control of the pharmacis t himse lf or of someother pharmacis t; and

se lle r ofpoisons

(b) the name and certifica te of regis tra tion of the pharmacis t having controlof the bus iness a re conspicuous ly exhibited in the premises .

35.-(l) A body corpora te carrying on bus iness compris ing the re ta il sa le ofpharmaceutica ls sha ll be an authorized se lle r of poisons within the meaning of

Conditionsfor body

corpora te to this Act if-become

(a ) with regard to the keeping, re ta iling, dispens ing and compounding ofauthorizedse lle r of pharmaceutica ls the bus iness is under the management of a superinte -

ndent who-poisons

(i) is a pharmacis t;(ii) has s igned, and sent to the Regis tra r, a s ta tement in writing on beha lf

of the body corpora te s ta ting his name and specifying whether or nothe is a member of tha t body;

(iii) is not a t the time acting in a s imila r capacity for any other bodycorpora te ; and

(b) in each se t of premises for the re ta il sa le of Pharmaceutica ls , the bus inessis ca rried on e ither under the persona l control of the superintendent or,subject to his directions , under the persona l control of a manager orass is tant who is a pharmacis t; and

(c) the name and certifica te of regis tra tion of the superintendent or of someother pharmacis t having control of the bus iness is conspicuous ly exhibitedin the premises .

(2) If-

(a ) a body corpora te which is an authorize se lle r of poisons has been convictedof an offence under this Act; or


(b) any member of the body corpora te or any of its office rs , or any office remployed by it in ca rrying on the bus iness , has been convicted of anycrimina l offence , or has been guilty of misconduct which, in the opinionof the Board renders him or would, if he were a pharmacis t, render him,unfit to be on the regis te r,

the Board may inquire into the matte r and may, subject to this Act, direct tha t-(i) the body corpora te cease to be an authorized se lle r of poisons , and be

disqua lified, for a period specified in the direction, from be ing an autho-rized se lle r of poisons ; or

(ii) any or a ll of the Premises of the body corpora te be removed from theregis te r of premises and be disqua lified, for a period specified in thedirection, from be ing regis te red.

(3) The Board may in any fit case , e ither on its own motion or on the applica-tion of the body corpora te concerned, direct the cessa tion of any disqua lifica tionimposed under this section.

36.-(1) Every authorized se lle r of poisons sha ll in the month of January ineach year send to the Regis tra r a lis t of a ll se ts of premises where he carries onbus iness in the re ta il sa le of pharmaceutica ls and the name of the pharmacis thaving the persona l control of the bus iness in each se t of premises .

(2) Any authorized se lle r of poisons who fa ils to comply with this section sha llbe guilty of an offence and sha ll be liable on conviction to a fine of one thousandshillings and to a further fine of two hundred shillings for every day subsequentto his conviction during which the default continues .

37.-(1) No person sha ll have any Part I poison in his possess ion unless -

(a ) he is entitled under this Part to se ll tha t poison or is a wholesa le dea le rlicenced under section 38 to se ll poisons ; or

(b) the poison has been sold or supplied to him by an authorized se lle r ofpoisons in accordance with this Act.

(2) In any proceedings for an offence under this section the burden to provetha t the poison has been sold or supplied by an authorized se lle r of poisons inaccordance with this Act sha ll lie upon the person in whose possess ion the poisonwas found.

38.--(l) Any person who wishes to dea l, or to continue dea ling, as a whole-Wholesa le

dear's

licence

sa le dea le r in poisons sha ll apply in writing in the prescribed form to the Board-

(2) Subject to any regula tions made under section 71, providing for the cance l-la tion or suspens ion of any license is sued or regis tra tion granted under this Act,the Board may, if it is sa tis fied tha t the public inte res t so requires , and uponpayment of the prescribed fee , is sue to the applicant a licence , or renew thelicence , permitting him to dea l as a wholesa le dea le r in poisons .

(3) A separa te licence under this section sha ll be required in respect of eachse t of premises in which the bus iness of the licensee in the sa le of poisons iscarried on.

(4) Notwiths tanding subsection (2), no licence sha ll be is sued or renewed underthis section unless the applicant is , or has a pharmacis t who res ides in theUnited Republic, in control of the dis tribution of the poisons .

(5) Every licence issued under this section sha ll expire on the 31s t day ofDecember of the year in which it is is sued, and may be renewed.

Lis t of

shops and

pharmacis ts

in charge

Possess ion

of Part I

poisons

prohibited

in certa in

cases

1918Pharmaceuticals and Poisons18 No. 9

(6) The Regis tra r sha ll keep a regis te r of a ll licences is sued by the Boardunder this section.

Licence to

dea l in

poisons for

mining,

agriculture

or hortcul-

tura l

purpose

39.-(1) Any person who wishes to carry on, or to continue carrying on,regula r bus iness in mining, agricultura l or horticultura l accessories sha ll apply

to the Board in writing in the prescribed form for a licence authorizing him to

se ll the poisons specified in the licence to persons who require them for a trade or bus iness of mining, agriculture or horticulture .

(2) Subject to any regula tions made under section 71 providing for the cance l-la tion or suspens ion of any licence issued or any regis tra tion granted under thisAct, the Board may, if it is sa tis fied tha t the public inte res t so requires , andupon payment of the prescribed fee by the applicant, is sue or renew the licence .

(3) A separa te licence under this section sha ll be required in respect of eachse t of premises in which the bus iness of the licence is ca rried on, and every suchlicence sha ll expire on the 31s t day of December in the year in which it is is sued,and may be renewed.

(4) The Regis tra r sha ll keep a regis te r of a ll licences is sued by the Boar dunder this section.

40.-(l) Subject to this Act, a person licensed under section 38 to dea l as awholesa le dea le r in poisons may se ll Part I poisons :-

Power tose ll Part Ipoisons

(a ) to another person so licensed;

(b) to an authorized se lle r of poisons ;

(c) in respect of the poisons specified in the purchaser's licence , to a personlicensed under section 39 to se ll those poisons for mining, agricultura l orhorticultura l purposes ;

(d) subject to a pharmacis t be ing in direct control of the poisons a tthe premises from which they a re sold, to a duly qua lified medica l practi-tioner, dentis t or ve te rinary surgeon for purposes of medica l, denta l orve te rinary trea tment respective ly;

(e ) subject to a pharmacis t be ing in direct control of the poisons a t thepremises from which they a re sold, to a hospita l, dispensary or s imila rins titution or a person ins titution concerned with scientific educa tion orresearch, where the hospita l, dispensary, ins titution or person has beenapproved in tha t beha lf by the Minis te r.

(2) Subject to this Act, an authorized se lle r of poisons may se ll Part I poisonsto any of the persons and ins titutions re fe rred to in subsection (1), and may, inaddition, se ll the poisons to any person who is :-

(a ) in possess ion of a prescription of a duly qua lified medica l practitioner,dentis t or ve te rinary surgeon, in accordance with the prescription; or

(b) in possess ion of a written certifica te to the e ffect tha t he may properly besupplied with the poison, such certifica te having been issued by a personauthorized by the Board in tha t beha lf, a lis t of which persons sha ll bepublished in the Gazette from time to time; or

(c) a person known by the se lle r to be a person to whom the poison mayproperly be sold.

(3) Subject to this Act, a person licensed under section 39 to se ll poisons for

mining, agricultura l or horticultura l purposes may se ll Part I poisons inaccordance with tha t licence .


(4) Subject to subsection (5), any person who --(a ) be ing an authorized se lle r of poisons or a person licensed under section 38

or under section 39 to dea l in poisons according to the te rms of the licence ,supplies any Part I poison to any person other than one to whom he isauthorized by this section to se ll tha t poison, or contra ry to the provis ionsof this Act re la ting to the sa le of Part I poisons ; or

(b) se lls any Part I poison in any other manner contra ry to this Act sha ll beguilty of an offence and sha ll be liable on conviction to a fine not exceed-ing five thousand shillings or to imprisonment for a te rm not exceedingtwelve months , or to both tha t fine and imprisonment.

(5) Nothing in this section sha ll make it illega l for any person to se ll or rese llto a wholesa le dea le r lincensed under section 38 or to an authorized se lle r ofpoisons , any s tocks of Part I poisons which a re found to be surplus to require -ments if:-

(a ) they a re lawfully in the possess ion of tha t person under this Act; or

(b) they were lawfully in the possess ion of tha t person under the Pharmacy

and Poisons Ordinance and a re sold by him within a period of s ix months Cap. 416

from the appointed day or such further time as the Minis te r may bynotice in the Gaze tte a llow.

41.-(l) Where any Part I poison is sold in the presence of the person by PoisonsBookwhom it is to be used, the se lle r sha ll not de liver it until:-

(a ) he has made or caused to be made an entry in a book kept for tha t purpose ,to be ca lled the Poisons Book, indica ting in the form prescribed theda te of the sa le , the name and address of the purchaser and of the person,if any, by whom the certifica te required under section 40 (2) (b) wasgiven, the name and quantity of the poison sold, and the purposes forwhich it is s ta ted by the purchaser to be required; and

(b) the purchaser has a ffixed his s igna ture to the entry made under para -graph (a ).

(2) Where any Part I poison is sold in the presence of an agent or employee ofthe person by whom it is to be used, or where the sa le is e ffected by pos t, thefollowing provis ions sha ll apply:

(a ) subject to subsection (3), before the sa le is comple ted the se lle r sha ll obta inan order in writing s igned by the purchaser, showing the purchaser's name,address and occupa tion, the name and quantity of the poison to bepurchased and the purpose for which it is required;

(b) before the sa le is comple ted the se lle r sha ll sa tis fy himse lf tha t the s igna tureon the order is tha t of the person by whom it purports to be s igned, andtha t person carries on the occupa tion s ta ted in the order, and inwhich the poison to be purchased is properly required;

(c) the requirements of subsection (1) as to the making of entries in thePoisons Book sha ll be complied with, except tha t in place of the purchaser'ss igna ture in the Poisons Book it sha ll be sufficient to ente r in the spaceprovided for the s igna ture the words ''s igned order'' toge ther with arefe rence whereby the particula r order may be readily identified;

(d) if the poison is sent by pos t it sha ll be sent by regis te red pos t.

(3) Where a person represents tha t he urgently requires a poison for thepurpose of his trade , bus iness or profess ion and sa tis fies the se lle r tha t by reasonof some emergency he is unable before de livery to furnish such order in writing,the se lle r may forthwith de liver the poison to the purchaser who sha ll, withintwenty-four hours of the sa le , furnish the se lle r with the written order re fe rred toin subsection (2) (a ).

20 No. 9 Pharmaceuticals and Poisons 1978

(4) All s igned orders and prescribed records of transactions to which thissection applies sha ll be re ta ined in the premises where the sa les were made fora period of five years .

(5) Any person who contravenes or fa ils to comply with this section sha ll beguilty of an offence and sha ll be liable on conviction to a fine not exceeding twothousand shillings or to imprisonment for a te rm not exceeding four months ,or to both tha t fine and imprisonment.

42.-(1) A qua lified medica l practitioner, dentis t or ve te rinary surgeon, orSupply anddispens ing of a member of the s ta ff of a hospita l, dispensary or s imila r ins titution who hasPart I

poisons

been authorized to do so by the genera l or specia l order of the Minis te r, maysupply or dispense a Part I poison for the purpose of medica l, denta l or ve te rinary

by doctors , trea tment, as the case may be , subject to the following provis ions :-hospita ls ,e tc.

(a ) the poison sha ll be dis tinctly labe lled with the name and address of theperson by whom it is supplied or dispensed;

(b) the following particula rs sha ll, within twenty-four hours a fte r the poisonhas been supplied or dispensed, be ente red in a book used regula rly for thepurpose , and which sha ll be ca lled the Prescription Book-

(i) the da te on which the poison was supplied or dispensed;

(ii) the ingredients and the quantity supplied;

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

(iv) the name and address of the person by whom the prescription wasgiven.

(2) Where an authorized se lle r of poisons supplies a Part I poison, formingpart of the ingredients of medicine for the inte rna l or exte rna l trea tment ofhuman a ilments , and where an authorized se lle r of poisons supplies a Part Ipoison on prescription, he sha ll ente r its particula rs in a Prescription Book keptin accordance with this section but sha ll not in respect of tha t supply be requiredto make any entry in the Poisons Book in accordance with section 41.

(3) Any person to whom subsection (1) applies and who supplies or dispensesany Part I poison in a manner contra ry to this section sha ll be guilty of an offenceand sha ll be liable on conviction to a fine not exceeding five thousand shillingsor to imprisonment for a te rm not exceeding twelve months , or to both tha t fineand imprisonment.

43.-(1) Every person who, not be ing otherwise empowered to do so, des ires toLicence to

se ll Part II se ll Part 11 poisons , sha ll apply in writing in the manner prescribed to thepoisons Regiona l Commiss ioner in charge of the dis trict in which he proposes to se ll the

poisons .

(2) If the Regiona l Commiss ioner, a fte r consulta tion with the Regiona lMedica l, Vete rinary or Agricultura l Officer, as the case may be , is sa tis fied tha tthe na tiona l inte res t requires tha t a licence under this section be is sued or renewedin order tha t the public may have adequa te facilities for obta ining Part 11poisons and tha t the applicant is a fit and proper person to se ll those poisons , andtha t the premises in which the bus iness is to be carried on a re suitable , he may, onpayment of the prescribed fee by the applicant, is sue or renew the licence .

(3) A licence under this section may be is sued in respect of a ll Part II poisonsor in respect of the Part if poisons specified in the licence and the Regiona lCommiss ioner may impose on the licence such conditions as he may think fit.

(4) Every licence issued under this section sha ll be in the prescribed formand sha ll expire on the 31s t December of the year in which it is is sued, andmay be renewed.

Pharmaceuticals and PoisonsNo. 9 211978

(5) A Regiona l Commiss ioner may, a fte r consulta tion with the Regiona lMedica l, Vete rinary or Agricultura l Officer, as the case may be , re fuse to is sueor renew a licence , or may rekove the licence of any person who, in his opinionis , for a reason re la ting e ither to the person or to his premises , not fit to holdthe licence .

(6) Every Regiona l Commiss ioner sha ll cause to be kept a regis te r in theprescribed form of a ll licences is sued by him under this section, and sha llforward to the Regis tra r a copy of each entry made in it.

(7) The Board may issue genera l or specia l directions to Regiona l Cornmis-s ioners as to the exercise of the power conferred by this section and everyRegiona l Commiss ioner to whom the ins tructions a re addressed sha ll complyand give e ffect to them.

(8) Where any person aggrieved by any decis ion made under this section by aRegiona l Commiss ioner appea ls in accordance with section 66, the decis ionsha ll not be quashed on the ground only tha t the Regiona l Commiss ionerfa iled to consult the Regiona l Medica l, Vete rinary or Agricultura l office r asrequired by subsection (2).

44.-(1) Subject to this Act, Part II poisons may be sold by-

(a ) a person licensed under section 38 to dea l as a wholesa le dea le r in poisons ,to the persons , departments and ins titutions to whom he is entitled undersection 40 to se ll Part I poisons , and to persons licensed to se ll Part IIpoisons ;

(b) an authorized se lle r of poisons ;(c) a person licensed under section 39 to se ll poisons for mining, agricultura l

and horticultura l purposes , in accordance with tha t licence ;

(d) a person licensed under section 43 to se ll Part 11 poisons , in accordancewith tha t licence .

(2) Subject to subsection (3), any person who se lls Part 11 poisons in anymanner contra ry to this Act sha ll be guilty of an offence .

..(3) Nothing in this section sha ll make it illega l for any person to se ll or rese llany s tocks of Part II poisons , found to be surplus to requirements , to a wholesa ledea le r licensed under section 38 or to an authorized se lle r of poisons .

45. (1) No poison sha ll be exposed or offe red for sa le in or by means of anautomatic machine .

(2) Any person who exposes or offe rs , or causes to be exposed or offe red, for machinessa le , any poison contra ry to subsection (1), sha ll be guilty of an offence .

46.-(1) Any person who, having been permitted or licensed under this Act topossess or se ll any poison, becomes for any reason disentitled to possess or se lltha t poison may, with the consent of the Board and subject to any conditions ordirections which the Board may impose , within nine ty days from the da te of hisdisentitlement, dispose of any s tocks of poison lawfully acquired by him prior tothe disentitlement.

(2) The persona l representa tive of any deceased person who immedia te lybefore his dea th was lawfully in possess ion of any poison under this Act, andany lawfully appointed liquida tor, rece iver or other person dea ling with the pro-perty of any person who has ceased to be entitled to possess any poison underthis Act may, with the written permiss ion, and subject to the directions of theboard, se ll tha t poison to a licensed wholesa le dea le r or to an authorized se lle r ofpoisons .

Power to

se ll Part II

poisons

Poison not

to be sold in

automatic

machines

Disposa l of

s tocks by

disentitled

person

22 No. 9 1978Pharmaceuticals and Poisons

Labeling and Advertisement

Labeling of 47.-(1) Subject to subsection (2), every poison sha ll be supplied in a conta inerconta iners labe lled in the prescribed manner-

(a ) with the name of the poison; and

(b) in the case of a pharmaceutica l product which conta ins a poison as one ofits ingredients . with the prescribed Particula rs as to the proportionwhich the poison conta ined in the product bears to the tota l ingredients ;and

(c) with the word ''Poison'' or other prescribed indica tion of the characte r ofthe a rticle ; and

(d) if supplied on re ta il or other sa le other than wholesa le , with the name Ofthe se lle r and the address of the premises on which it is sold; and

(e) if supplied, but not on sa le , with the name and address of the supplie r.

Labeling of 48.-(l) Subject to this Act, no person sha ll se ll by re ta il any a rticle cons is tingof or compris ing a subs tance recommended as a medicine unless there is legiblywritten on the a rticle or on the labe l a ffixed to it, or, if the a rticle is sold orsupplied in a conta iner, on the conta iner Or on the labe l a ffixed to it, or if thearticle is sold or supplied in more than One conta iner, on the inner conta iner or ona labe l a ffixed to it-

articlesconta iningmedicine

(a ) the appropria te des igna tion of the subs tance so recommended or of each ofits active cons tituents , or of each of the ingredients of which it has beencompounded; and

(b) in a case where the appropria te des igna tion of each of the active cons ti-tuents or ingredients is written, the appropria te quantita tive particula rs ofthe cons tituents or ingredients .

(2) Subsection (1) sha ll not apply--

(a ) to any a rticle made up and supplied for the use of a particula r personbeing on a rticle prescribed by re fe rence to the needs of tha t person;

(b) for a period of s ix months from the appointed day.

(3) In subsection (I)-

(a ) the express ion ''appropria te des igna tion'' in re la tion to a subs tance ,cons tituent or ingredient means-

(i) in a case where the subs tance , cons tituent or ingredient is a poisonincluded in the Poisons Lis t, the name with which the conta iner of thepoison is for the time be ing required to be labe lled in Pursuance ofsection 47;

(ii) in case where the subs tance , cons tituent or ingredient is not tha t poisonand is described in any of the monographs conta ined in the edition ofthe British Pharmaceutica l Codex or the inte rna tiona l Pharmacopoeiaor the British Vete rinary Codex which was las t published before theda te on which the a rticle was sold or supplied, the description se t outa t the head of tha t monograph;

(iii) in a case where the subs tance , cons tituent or ingredient is not tha tpoison and is not described thus , the accepted scientific name, or othername descriptive of the true na ture of the subs tance , cons tituentor ingredient,

and in a ll cases the appropria te name of the subs tance sha ll be written in Englishor La tin and in addition where it exis ts , in the officia l Kiswahili equiva lent;


(b) the express ion ''appropria te quantita tive particula rs '', in re la tion to theactive cons tituents of the ingredients of a subs tance , means-

(i) the approximate . percentage of each of those cons tituents or ingre-dients conta ined in the subs tance or the approximate quantity of eachof those cons tituents or ingredients conta ined in the a rticle sold orsupplied; or

(ii) in a case where the a rticle cons is ts of or comprises a number of sepa-ra te portions of the subs tance , e ither the approximate percentage orquantity, of the approximate quantity, of each of those cons tituents oringredients conta ined in each portion; and

(c) the express ion ''conta iner'' includes a wrapper.

(3) If any person se lls or supplies an a rticle in contravention of this section, hesha ll, subject to this Act, be guilty of an offence and sha ll be liable on conviction-

(a ) in the case of a firs t conviction, to a fine not exceeding five hundredshillings ; and

(b) in the case of a subsequent conviction, to a fine not exceeding threethousand shillings or to imprisonment for a te rm not exceeding fourmonths , or to both tha t fine and imprisonment.

(4) it sha ll be a defence for a person charged with se lling or supplying, incontravention of any of the provis ions of this section, an a rticle cons is ting of orcompris ing a subs tance recommended as medicine to prove-

(a ) tha t he did not know, and had no reason to be lieve , tha t the a rticlecons is ted of or comprised such a subs tance ; or

(b) tha t, in re la tion to the matte r in respect of which he is charged, he acted inthe course of his employment as an employee or agent of another personon the ins tructions of his employer or of some other specified person.

49.-(1) subject to this Act, no person sha ll take any part in the publica tion ofany advertisement re fe rring to any pharmaceutica l product, appliance or a rticleof any description in te rms which a re ca lcula ted to imply tha t the product,appliance or a rticle may be e ffective for any of the purposes specified in theSecond Schedule to this Act.

(2) In any proceedings for a contravention of subsection (1), it sha ll be adefence for the accused person to prove tha t the advertisement concerned waspublished only so fa r as was reasonably necessary to bring it to the notice of oneor more of the persons in the following ca tegories -

(a ) members of Parliament;

(b) qua lified medica l practitioners , dentis ts and ve te rinary surgeons ;

(c) pharmacis ts , authorized se lle rs of poisons and licensed wholesa le dea le rs ;

(d) persons carrying on a bus iness which includes the sa le or supply of surgica lappliances ,

or tha t the advertisement was so published in connection with an applica tion fora pa tent submitted to the appropria te authority so fa r only as was requis ite forthe purpose of the applica tion.

(3) The Minis te r may, from time to time , by notice in the Gazette , amend orvary the Second Schedule to this Act.

Prohibition

of adverti-

sement as

to certa in

diseases , e tc


Prohibition

of adverti-

sements as

to abortion

50.- Subject to this Act, no person sha ll take any part in the publica tion of anyadvertisement re fe rring to any pharmaceutica l product, appliance or a rticle ofany description, in te rms which a re ca lcula ted to lead to the use of tha t product,appliance or a rticle for procuring miscarriage by women.

False

labe ling and

advertise -

ment

51.-(1) Any person who gives out or displays , with any pharmaceutica lproduct, medicine , medica l appliance or s imila r a rticle sold or exposed by him forsa le , a labe l, whether or not a ttached to or printed on the conta iner or wrapper,which-

(a) fa lse ly describes the product, medicine , medica l appliance or a rticle ; or

(b) is ca lcula ted to mis lead as to the na ture , subs tance or qua lity of the produ-ct, medicine , medica l appliance or a rticle ; or

(c) re fe rs to the product, medicine , medica l appliance or s imila r a rticle inte rms which a re extravagant and bear little or no re la tion to the thera -peutic properties and action of the ir ingredients or components ,

sha ll be guilty of an offence , unless he proves to the sa tis faction of the court tha the did not know, and could not with reasonable diligence have ascerta ined, tha tthe labe l cancerned was of the characte r it is a lleged to be , and sha ll be liableon conviction to a fine not exceeding ten thousand shillings .

(2) Subject to subsection (3), any person who publishes , or is a party to thepublica tion of an advertisement, not be ing a labe l given out or displayed by him,which has the same effects as those re fe rred to in subsection (1) (a ), (b) or (c),sha ll be guilty of an offence and sha ll be liable on conviction to a fine notexceeding ten thousand shillings .

(3) In proceedings for an offence under subsection (2), it sha ll be a defence fora defendant to prove , e ither-

(a ) tha t he did not know, and could not with reasonable diligence haveknown, tha t the advertisement was of the characte r described in tha tsubsection; or

(b) tha t, be ing a person whose bus iness it is to publish or a rrange for thepublica tion of advertisements , he rece ived the advertisement for publica-tion in the ordinary course of bus iness .

(4) In any proceedings under this part, the fact tha t a labe l or advertisement inrespect of which the offence is a lleged to have been committed conta ined anaccura te s ta tement of the compos ition of the pharmaceutica l product sha ll notpreclude the court from finding tha t the offence was committed.

PART V

ENFORCEMENT AND LEGAL PROCEEDINGS

S ampling and Analys is

Power to 52.-(1) Subject to subsection (2) and to subsection (3), any inspector maytake samples take samples for ana lys is , or for bacte riologica l or other examina tion, of any

pharmaceutica l product, or of any subs tance capable of be ing used in themanufacture of pharmaceutica ls , which appears to him to be intended for sa leor to have been sold for use by man, or which is found by him on or in anypremises , s ta ll, vehicle , vesse l, a ircra ft or place which he is authorized to ente r forthe purposes of ensuring compliance with this Act.

(2) The inspector sha ll Pay or tender payment of the marke t price of thesample he takes or, if the marke t price is unknown or not readily ascerta inable ,a reasonable price , to the person appearing to him to have the lawful cus tody ofthe pharmaceutica l product a sample of which the inspector takes .


(3) Where the pharmaceutica l product or subs tance a sample of which theinspector intends to take , is kept for re ta il sa le in unopened packages , the samplesha ll cons is t of the whole of any one package .

(4) When taking any sample under this section, the inspector sha ll take anynecessary measures to sa tis fy himse lf tha t the sample taken is a fa ir sample of thebulk of the pharmaceutica l product.

(5) Any person who fa ils to comply with any demand made by an inspectorunder this section sha ll be guilty of an offence and sha ll be liable on convictionto a fine not exceeding one thousand shillings or to imprisonment for a te rm notexceeding s ix months . or to both tha t fine and imprisonment.

53.-(1) Any inspector who has procured a sample of any pharmaceutica lproduct or other subs tance for use in the manufacture of pharmaceutica ls sha ll,if he cons iders tha t it should be ana lysed, submit it to the Government Analys tfor ana lys is ; and any other person who has purchased any pharmaceutica lproduct may submit a sample of it to the Government Analys t for ana lys is .

(2) Subject to section 59 and to any regula tions made under section 71. theGovernment Analys t sha ll ana lyse as soon as may be practicable any samplesubmitted to him in pursuance of this section, but sha ll, where a sample is sub-mitted by a person other than an inspector, demand the prescribed fee to be pa idprior to the ana lys is be ing done .

54.-(1) Where any inspector who has taken a sample of any pharmaceutica lproduct or subs tance under section 52 cons iders tha t it should be ana lysed. hesha ll divide the sample into three parts , each part to be marked and sea led orsecured in the manner permitted by its na ture and sha ll-

(a ) with respect to one part of the sample , comply with subsection (2); and

(b) with respect to the remaining parts of the sample comply with subsection(3).

(2)-(a ) If the sample was obta ined by purchase from a dea le r in the pharma-ceutica l product or subs tance concerned, the inspector sha ll permit the vender tose lect and take one part from the three parts .

(b) If the sample is of any pharmaceutica l product or subs tance cons ignedfrom outs ide the United Republic and was taken by tha t office r beforede livery to the cons ignee , he sha ll give the one part of the sample to thecons ignee .

(c) If the sample is of any pharmaceutica l product or subs tance in trans it froma cons igner within the United Republic to a cons ignee within or outs idethe United Republic, the inspector sha ll give the one part of the sample tothe cons igner.

(d) If none of the preceding paragraphs of this subsection applies , the ins -pector sha ll give the one part of the sample to the person appearing to himto be the owner of the pharmaceutica l product or subs tance from which thesample was taken.

(1) The inspector sha ll unless he subsequently decides not to have an ana lys iswade , submit to the Government Analys t one of the remaining two parts of thesample and re ta in the other for future comparison.

(4) In every case to which subsection (2) applies , the inspector sha ll informthe person to whom the part of the sample is given tha t sample was taken forana lys is by the Government Analys t.

Right to

have sample

ana lysed

Provis ions

regarding

the taking

of samples

for ana lys is

Pharmaceuticals and Poisons 197826 No. 9

(5) Where any sample taken for ana lys is cons is ts of the contents of an un-opened package , the inspector sha ll re ta in the packing materia l and, if he decidesto have an ana lys is made , de liver the sample toge ther with tha t packing materia land any labe l which may have been a ttached to it a t the time when the samplewas taken to the Government Analys t with the part of the sample submittedpursuant to subsection (3).

(6) Any part of a sample which is to be given to any person under this sectionmay be given e ither by de livering it to him or his agent, or by sending it to him bypos t in a regis te red packe t; but if a fte r reasonable inquiry the inspector is unableto find the person to whom the Part of the sample is to be given or to ascerta inhis name and address , he may, in lieu of giving tha t part to tha t person, re ta in it.

(7) If it appears to the inspector tha t any pharmaceutica l product or subs tanceof which he has taken a sample for ana lys is was manufactured or putinto a wrapper or conta iner by a person other than one to whom any part of thesample is required to be given, having his name and an address in the UnitedRepublic displayed or written on the wrapper or conta iner, the inspector sha ll,unless he subsequently decides not to have an ana lys is made , within three daysafte r taking tha t sample , send to tha t person a notice informing him tha t thesample has been taken by him and where the sample was taken or, as the casemay be , from whom it was purchased.

Where 55. Where an inspector procures a sample cons is ting of a pharmaceutica l pro-duct or subs tance conta ined in unopened packages and the divis ion into partsof the pharmaceutica l product or subs tance in the packages-

divis ionof sampleinto parts

(a ) is not reasonable ; orimpracticable

(b) might a ffect the compos ition or impede the proper ana lys is of the contents ,the inspector sha ll be deemed to have complied with section 54(2) if he dividesthe conta iners into the requis ite number of lots and dea ls with each lot as if itwere a part in the manner provided by tha t section and re fe rence in this Act toa part of a sample sha ll be cons trued accordingly.

Enforcement

Appointment 56.-(l) For the purposes of this Act, every member of the , Board, and everyof inspectors Regiona l Medica l Officer, sha ll be an inspector.

(2) The Board may authorize in writing any public office r to be an inspectorfor the purposes of this Act.

57.-(1) For the purposes of ensuring compliance with this Act, an inspectorPower ofmay-inspectors

(a ) a t a ll reasonable times , ente r-

(i) any premises which a re on the regis te r of premises ;

(ii) any premises in which any person whose name is ente red in anyregis te r under this Act ca rries on any bus iness and;

(iii) any premises m respect of which any person is licensed under thisAct;

(b) a t any time ente r any premises in which he has reasonable cause to suspecttha t this Act has been, or is about to be , contravened in re la tion to anypoison specified in the Poisons Lis t;

(c) examine or inspect any certifica te of regis tra tion, licence , book or otherdocument in the premises and, for tha t purpose , he may do such otherthings , including the taking of extracts from documents in the possess ionof the pharmacis t, a s may be necessary to e ffectua te the examina tion orinspection;


(d) se ize and de ta in any pharmaceutica l product, subs tance or a rticle cons is -ting of or conta ining any poison which he has reasonable cause to suspectis liable to forfe iture under this Act;

(e ) se ize and de ta in any pharmaceutica l product, a rticle , record or other thingwhich appears to him to cons titute or conta in evidence of a contraventionof any provis ion of this Act.

(2) Any person who-

(a ) willfully de lays or obs tructs an inspector in the exercise of his powersunder this section; or

(b) re fuses or fa ils without reasonable excuse , to give any information whichhe is lawfully required under this section to give ; or

(c) gives any information which is fa lse in a materia l particula r or which hereasonably be lieves to be untrue ,

sha ll be guilty of an offence and sha ll be liable on conviction to a fine not exceed-ing two thousand shillings or to imprisonment for a te rm not exceeding twelvemonths or to tha t fine and imprisonment.

(3) Without pre judice to the genera lity of subsections (2) and (3), every personwho appears to be conducting in any premises any bus iness involving the re ta ilsa le of drugs sha ll, on be ing required to do so by an inspector, s ta te who the ownerof the bus iness is , and if tha t person fa ils , without reasonable excuse , to complywith this subsection, he sha ll be guilty of an offence and sha ll be liable on convic-tion to a fine not exceeding five hundred shillings .

58.-(1) The Minis te r may, on the recommendation of the Board, by orderin the Gazette , prohibit or control the manufacture , importa tion, sa le , advertise -ment or possess ion of any secre t, pa tent, proprie ta ry or homoeopathic medi-cine , prepara tion or appliance , or any drug, pharmaceutica l prepara tion ortherapeutic subs tance .

(2) Any person who contravenes or fa ils to comply with any order madeunder subsection (1) sha ll be guilty of an offence and sha ll be liable on convictionto a fine not exceeding five thousand shillings .

Legal Proceedings

59.-(1) In every case in which a sample for ana lys is is de livered to theGovernment Analys t under section 54, the Analys t sha ll cause it to be ana lysedas soon as is practicable and sha ll give to the person who reques ted the ana lys isto be made a certifica te specifying the result of the ana lys is in the form prescribedin the Third Schedule to this Act.

(2) Where a sample taken under section 52 has been ana lysed by the Govern-ment Analys t, any person t o whom a part of the sample was given inaccordance with section 54 (2) sha ll, on payment of the prescribed fee , be suppliedwith a copy of the certifica te by the Government Analys t.

(3) A certifica te of the result of an ana lys is given by the Government Analys tunder subsection (1) sha ll be s igned by him, but the ana lys is may be made byany person acting under his ins tructions .

(4) Any person who, for the purpose of advertisement, uses any certifica te ofana lys is obta ined under this section sha ll be guilty of an offence and sha ll beliable on conviction to a fine not exceeding one thousand shillings .

Power to

prohibit or

control

certa in

medicine ,

e tc.

Certifica te

of ana lys is

1978Pharmaceuticals and Poisons28 No. 9

Evidence of 60.-(1) In any proceedings for an offence under this Act, the production byone of the Parties of a document purporting to be a ce rtifica te of the Govern-ment Analys t given under section 59, or of a document supplied to him by theother party as be ing a copy of tha t ce rtifica te , sha ll be sufficient evidenceof the facts s ta ted in it, unless , in the former case , the other party requirestha t the person who made the ana lys is be ca lled as a witness .

ana lys is

(2) In any proceedings for an offence under this Act, if a defendant intendsto produce a certifica te of the Government Analys t, or to require , under sub-section (1), tha t the person who made the ana lys is be ca lled as a witness , hesha ll give notice of tha t intention to the other party, toge ther, in the formercase , with a copy of the certifica te , three days before the da te fixed for hearingof the case and, if the notice is not given, the court may, if it thinks fit, adjournthe hearing on te rms which it cons iders proper.

(3) If any re levant method of ana lys is has been prescribed under this Act,evidence of an ana lys is ca rried out by tha t method sha ll be pre fe rred to evidenceof any other ana lys is or tes t.

(4) In any proceedings under this Act, where a sample has been procured incircumstances which necess ita te the requirement tha t it be divided into parts ,the part of the sample re ta ined by the Person who took it sha ll be producedat the hearing.

Presump- 61.-(l) For the Purposes of this Act-tions

(a ) any pharmaceutica l product commonly used by man sha ll, if sold oroffe red, exposed or kept for sa le , be presumed until the contra ry is proved,to have been sold or, as the case may be , to have been or to be intendedfor sa le for use by man,

(b) any pharmaceutica l product commonly used by man, or any a rticlecommonly used in the manufacture of pharmaceutica ls for use by man,which is found on any Premises or in any vesse l, vehicle , a ircra ft orconta iner used for the manufacture , s torage , transport or sa le of tha tpharmaceutica l product or a rticle sha ll be presumed until the contra ry isproved, to be intended for sa le or, as the case may be , for the manufactureof pharmaceutica ls , for use by man,

(C) any subs tance capable of be ing used in the compos ition or manufactureof any pharmaceutica l product commonly used by man which is foundon any premises or in any vesse l where tha t pharmaceutica l product ismanufactured sha ll be presumed to be intended for tha t use .

(2) Where any pharmaceutica l product for use by man is sold, or depos itedwith or cons igned to any Person for the purpose of sa le for use by man in anunopened Package , any person who appears from any s ta tement on or a ttachedto the package to have enclosed it in tha t package sha ll, until the contra ryis proved, be deemed to have imported, manufactured or enclosed tha t pharma-ceutica l product.

62.-(1) In any proceedings for an offence which cons is ts of se lling, oroffe ring, expos ing or advertis ing for sa le or having in possess ion for the purposeof sa le , any Pharmaceutica l product or subs tance , it sha ll be a defence for thedefendant to prove-

Whenwarrantymay bepleaded asdefence

(a ) tha t he purchased it as be ing an a rticle or subs tance which could lawfullybe sold or dea lt with under the name or description or for the purposeunder or for which he sold or dea lt with it, and with a written warrantyto tha t e ffect; and


(b) tha t be had no reason to be lieve , a t the time when the a lleged offencewas committed, tha t it was something other than what he says it was inparagraph (a ); and

(c) tha t it was then in the same s ta te as when he purchased it.

(2) A warranty sha ll only be a defence in proceedings under this Act if-

(a ) the defendant-

(i) has , not la te r than three days before the da te of the hearing, sentto the prosecutor a copy of the warranty with a notice tha t heintends to re ly on it and specifying the name and address of the

person from whom he rece ived it; and

(b) in the case of a warranty given by a person res ident outs ide the UnitedRepublic, the defendant proves tha t he had taken reasonable s teps toascerta in, and did in fact be lieve in, the accuracy of the s ta tement conta inedin it.

(3) A defendant who is an employee or agent of the person who purchasedthe a rticle or subs tance under a warranty may re ly on this section in the sameway as his employer or principa l would have done had be been the defendant.

(4) The person by whom the warranty is a lleged to have been given mayappear and give evidence a t the bearing, and the court may, if it thinks fit,adjourn the bearing to enable him to do so.

(5) For the purposes of this section and of section 63, a name or descriptionente red in an invoice sha ll be deemed to be a written warranty tha t the a rticle orsubs tance to which the entry re fe rs can be sold or dea lt with in any other wayunder tha t name or description by any person without centravening this Act.

63.-(1) A defendant who in any proceedings under this Act willfully applies toany a rticle or subs tance a warranty or ce rtifica te of ana lys is given in re la tion toany other a rticle or subs tance sha ll be guilty of an offence and sha ll be liable onconviction to a fine not exceeding one thousand shillings or to imprisonment fora te rm not exceeding s ix months , or to both tha t fine and imprisonment.

(2) Any person who, having sold any a rticle or subs tance in respect of which awarranty might be pleaded under section 62, gives to the purchaser a fa lsewarranty in writing is guilty of an offence , unless he proves tha t when he gave thewarranty he had reason to be lieve tha t the s ta tements or description conta inedin it were accura te , and sha ll be liable on conviction to a fine not exceeding threethousand shillings .

64.-(l) Where a person is convicted of an offence under this Act, the courtmay order tha t a ll expenses incidenta l to the taking of any sample or the makingof any ana lys is of any pharmaceutica l product in respect of which the convictionis obta ined sha ll be pa id by the person convicted.

(2) All expenses recoverable under this section sha ll be recovered in the samemanner as a fine is recovered.

65.-(1) In any proceedings for an offence under this Act, the court beforewhich the offence is tried may, in addition to any order or sentence it makes orimposes , order tha t any pharmaceutica l product, subs tance or other a rticle withrespect to which the offence was committed be forfe ited to the government ofthe United Republic.

(2) An order of forfe iture may be made under this section whether or not anyperson has been convicted of the offence a lleged to have been committed.

(ii) has a lso sent a like notice to tha t person; and

Offences in

re la tion to

warranties

or ce rtifica tes

of ana lys is

Recovery of

expenses

incidenta l

to taking of

samples

Forfe iture

30 Pharmaceuticals and Poisons 1978No. 9

(3) Any pharmaceutica l product, subs tance or other a rticle in respect of whichan order for forfe iture is made under this section sha ll be deemed to be free fromany rights of any Person-

Appeals 66.-(1) Any person aggrieved by a decis ion of the Board re la ting to his licenceor regis tra tion, or to a matte r which a ffects or may a ffect the va lidity of his licenceor regis tra tion, under this Act, may appea l to the High Court aga ins t tha tdecis ion.

(2) The Board may appear as respondent and be heard on any appea l aga ins tits decis ion and, for the purposes of enabling directions to be given as to thecos ts of the appea l, the Board sha ll be deemed to be a party to the appea l,whether or not it appears a t the hearing of the appea l.

(3) Appea ls made under this section sha ll be regula ted by written laws for timebe ing in force and rules of court made by the Chief Jus tice re la ting to theadmiss ion and disposa l of appea ls in crimina l proceedings .

(4) Where on an appea l under this section the High Court varies or reversesany decis ion of the Board, the Board sha ll give e ffect to the order of the Court,and in particula r, sha ll grant or renew the licence or regis tra tion concerned,as the case may be .

6,7,-When a decis ion of the Board Or of a court in any proceedings for anoffence under this Act makes it unlawful for a person to carry on any bus inesswhich he was lawfully carrying On a t the da te when tha t decis ion was given, orto use any premises for any purpose for which he was lawfully us ing them a t tha tda te , he may carry on tha t bus iness and use the premises for tha t purpose untilthe time for appea ling has expired, and if any appea l is lodged, until the appea lis fina lly disposed of or abandoned or withdrawn.

Right tocarry onbus inesspendingappea l

PART VI

MISCELLANEOUS PROVISIONS

this Act sha ll not apply to-subs tances 68.-(1) Subject to subsection (2),used in loca l (a ) the possess ion, sa le or manufacture , of any subs tance cus tomarily used insys tems of

a sys tem of therapeutics according to loca l methods by a person to whomsection 37 of the Medica l practitioners and Dentis ts Ordinance applies ,who possesses se lls , prepares , mixes , compounds or in any other way

manufactures the subs tance in a bonafide practice of tha t sys tem; or

therapeutics

Cap. 409

(b) the possess ion by any member of the community to which tha t personbelongs of tha t subs tance rece ived from tha t person.

(2) Nothing in this section sha ll be cons trued as authorizing any person-(i) to se ll or manufacture any subs tance to or for any person other than

a member of the community to which he be longs , or

00 to se ll or supply tha t subs tance in quantities or prepara tion whichare , or a re like ly to be , dangerous to life ; or

(iii) to add any subs tance manufactured by him to any pharmaceutica lsmanufactured in a sys tem of therapeutics other than his sys tem.

69. No matte r or thing done by any member of the Board, the Regis tra r, an inspector or any other Person empowered to perform any function under this Act sha ll, if done in good fa ith in execution or purported execution of hisfunctionother person persona lly liable for the matte r or thing concerned.

power to

de lega te

70. The Minis te r may, by order in the Gazette , empower the Board to de lega teto any of its members or to the , Regis tra r any function conferred upon the Boardby this Act.

Liability of

members of

Board, e tc.

31Pharmaceuticals and Poisons 1978No. 9

71.-(1) The Minis te r may, a fte r consulta tion with the Board, make Regula tions

regula tions with respect to any of the following matte rs or for any of thefollowing Purposes-

(a ) prohibiting the re ta il sa le of any specified Part I Poison except ona prescription lawfully given by a qua lified medica l practitioner, dentis tor ve te rinary surgeon, and for Prescribing the form and regula ting the useof those prescriptions ;

(b) prohibiting, regula ting or res tricting the sa le of Part 11 poisons or of anyspecified Part II poisons by any of the persons licensed under section 39or section 43, or by any ca tegory of those persons ;

(c) exempting from any of the provis ions of this Act re la ting to the sa le ofpoisons any a rticle or subs tance conta ining poison or any ca tegory of sucharticles or subs tances or for dispens ing with or re laxing any provis ionconta ined in Part IV of this Act with respect to poisons ;

(d) providing for the be tte r regula tion of the manufacture , sa le or advertis ingof pharmaceutica ls , poisons and therapeutic subs tances ;

(e ) the sa fe cus tody, s torage and transport of pharmaceutica ls and poisons ;(f) the e ffective regula tion of the importa tion, exporta tion, and labe llig of

pharmaceutica ls and poisons ;(g) the conta iners in which poisons may be supplied;(h) the addition to poisons of specified ingredients for the purpose of rendering

them readily dis tinguishable as poisons ;(i) the compounding and dispens ing of poisons ;

(j) prescribing the forms , the manner, the procedure and the fees payable inrespect of applica tions for licences or regis tra tion under this Act;

(k) prescribing, a fte r consulta tion with the Board, the additiona l requirementsre la ting to experience re fe rred to in section 8(l) (c);

(1) the conduct of inquiries by the Board, and the a ttendance of witnesses andproduction of evidence a t inquiries under this Act, including the power totake evidence on oa th;

(in) prescribing the grounds for suspens ion or cance lla tion of a licence issuedor regis tra tion granted under this Act;

(n) anything which is required or permitted to be prescribed or provided forunder this Act.

(2) The power to make regula tions under this section in re la tion to poisonincludes the power to make rules in re la tion to any ca tegory of poisons or drugor any particula r poison or drug.

72.-(1) The Board may, with the consent of the Minis te r make by-laws for By-the be tte r ca rrying out of its functions under this Act and without pre judice to bythe genera lity of the power conferred by this subsection, the Board may by suchby-laws:-

(a ) prescribe diplomas which sha ll be recognized as entitling the holder toregis tra tion under this Act;

(b) prescribe e thics for the practice of the profess ion of pharmacy;

(c) prescribe rules to regula te the s tandards of profess iona l conduct ofpharmacis ts ;

(d) provide for and regula te the manner of giving ass is tance to members ofthe public on matte rs touching upon, ancilla ry or incidenta l to, the practiceof the profess ion of pharmacy;

(e ) prescribe anything which, in the opinion of the Board, is incidenta l orconducive to the exercise of its functions and powers under this Act.

(2) By-laws made by the Board under this section sha ll be published in theGaze tte .

By-laws

by Board

No. 932 1978pharmaceuticals and Poisons

PART VII

REPEAL AND CONSEQUENTIAL PROVISIONS

,13.-(1) The Food and Drugs Ordinance , in so fa r as it re la tes to theRepea l ofCap. 93 regula tion of the manufacture , importa tion and sa le of pharmaceutica ls , is herebyand Cap. 416 repea led.

(2) The Pharmacy and Poison Ordinance is hereby repea led.

(3) Subject to the provis ions of this Part, every licence or permit and everyregis tra tion issued to or granted in respect of any person under the Food andDrugs Ordinance or under the Pharmacy and Poisons Ordinance , entitling tha tperson to dea l in any manner with pharmaceutica ls and poisons , or to carry onbus iness in any other way as a pharmacis t, sha ll, from the appointed day. bedeemed to have been revoked.

Savings 74.-Notwiths tanding the repea l of the Food and Drugs ordinance as it re la testo pharmaceutica ls , and tha t of the Pharmacy and Poisons Ordinance-

(a ) a ll subs idia ry legis la tion made under the Food and Drugs ordinance inre la tion to pharmaceutica ls , and a ll subs idia ry legis la tion made under thepharmacy and Poisons Ordinance , which is in force on the appointed daysha ll be deemed to be subs idia ry legis la tion made under this Act, andsha ll remain in force until revoked by regula tions or rules made under thisAct;

(b) a ll office rs appointed under the Food and Drugs Ordinance or the Phar-macy and Poisons Ordinance to perform functions in re la tion to 'thecontrol of the manufacture , importa tion or sa le of pharmaceutica ls andpoisons , and a lso in re la tion to the regula tion of the profess ion of phar-macy, sha ll continue to Perform those duties in so fa r as this Act re la tes tothem unless the ir tenure of office expires or the ir appointments a re soonerte rmina ted or, as the case may be , they a re reappointed and sha ll, for tha tpurpose , be deemed to have been appointed under this Act.

75.-(1) Notwiths tanding any provis ion in this Act to the contra ry, theMinis te r may, on the recommendation of the Board and upon be ing sa tis fied tha tspecia l circumstances exis t which make it jus t and equitable to do so, permit anyperson who was licensed, regis te red or permitted in any other Way under theFood and Drugs Ordinance or the Pharmacy and Poisons Ordinance to dea l inany manner with or in connection with pharmaceutica ls or poisons to continuedoing so, a fte r the appointed day, upon conditions de te rmined by the Minis te r-

Trans itiona lprovis ions

(2) The Minis te r may, by notice in the Gazette , a t any time before the expiryof twelve months from the appointed day, make such consequentia l, trans itiona lor supplementary Provis ions as he may cons ider necessary consequent upon therepea l of the Food and Drugs Ordinance as it re la tes to pharmaceutica ls , and thePharmacy and Poisons Ordinance , or for facilita ting the assumption by theBoard of its functions under this Act.

FIRST SCHEDULE

(Section 3(2))compos ition 1. The Board sha ll cons is t of-of Board (a ) the Director of Medica l Services , who sha ll be the Chairman;

(b) a lega lly qua lified person holding office in the Attomey-Genera l's Chambers ,nomina ted in tha t beha lf by the Attorney-Genera l;

,) the Chief Vete rinary office r or his representa tive ;(d) the chie f Agricultura l Officer;(e ) the Chief Pharmacis t in the se rvice of the Government;(f) the Chemis t;


(g) two pharmacis ts appointed by the Minis te r;

(h) one qua lified medica l practitioner appointed by the Minis te r;

(i) three other members appointed by the Minis te r.

2. The members sha ll e lect one of the ir number to be the Vice-Chairman of the Boardand any member e lected as Vice-Chairman sha ll, subject to his continuing to bea member, hold office for a te rm of one year from the da te of his e lection, but sha ll bee ligible for re -e lection.

3. A member appointed under paragraph I (g), (h) and (i)-

(a ) sha ll, unless his appointment is sooner te rmina ted by the Minis te r, or he ceasesin any other way to be a member, hold office for a period of three years but sha ll

be e ligible for re -appointment;

(b) may a t any time res ign his office by giving notice in writing addressed to theMinis te r, and from the da te specified in the notice or, if no da te is so specified,from the da te of the rece ipt of the notice by the Minis te r, he sha ll cease to bea member.

4.-(1) The Board sha ll ordinarily meet a t such times and places as it deems necessaryfor the transaction of its bus iness , but sha ll mee t a t leas t once every three months .

(2) The Chairman or, in his absence , the Vice-Chairman, may a t any time ca ll aspecia l mee ting of the Board, and sha ll ca ll a specia l mee ting upon a written reques tby a majority of the members in office .

(3) The Chairman, or in his absence the Vice-Chairman, sha ll pres ide a t everymeeting of the Board. In the absence of both the Chairman and the Vice-Chairman,the members present sha ll appoint a member from amongs t themselves to pres ideover the meeting.

5. The quorum a t any meeting of the Board sha ll be five , of whom one sha ll be apharmacis t and one a qua lified medica l practitioner.

6.-(I) Subject to sub-paragraph (2), ques tions proposed a t a meeting of theBoard sha ll be decided by a majority of the votes of members present and voting,and in the event of an equa lity of votes then the person pres iding sha ll have a cas tingvote in addition to his de libera tive vote .

(2) A decis ion may be made by the Board without a meeting by circula tion of there levant papers among the members and the express ion of the views of the membersin writing, but any member may require tha t the decis ion be defe rred and the subjectmatte r be cons idered a t a meeting of the Board.

7.-(1) The Board sha ll cause to be recorded and kept de ta ils of a ll bus iness conductedor transacted a t its mee tings , and the minutes of each meeting of the Board sha ll beread and confirmed, or amended and confirmed, a t the next meeting of the Board ands igned by the person pres iding a t tha t mee ting.

(2) Any minutes purporting to be s igned by the person pres iding a t a meeting ofthe Board sha ll, in the absence of proof of e rror, be deemed to be a correct record ofthe meeting whose minutes they purport to be .

8. The va lidity of any act or proceeding of the Board sha ll not be a ffected by anyvacancy among its members or by any defect in the appointment of any of them.

9. Subject to the provis ions of this Schedule , the Board may regula te its own pro-ceedings .

Board may

regula te its

ownproceedings

Vice-

Chairman

Tenure of

office

Meeting of

the Board

Quorum

Decis ions of

the Board

Minutes of

meetings

Vacancies ,

e tc, not to

inva lida te

proceedings

No. 934 Pharmaceuticals and Poisons 1978

10. Any document Purporting to be under the hand of the Regis tra r as to any resolu-Proof ofdocuments tion of the Board or as having been issued on beha lf of the Board, sha ll be rece ivable

in a ll courts or tribuna ls or other bodies authorized to rece ive evidence and sha ll,unless the contra ry is shown, be deemed, without further proof, to be sufficient evidenceof what is conta ined in the document.

SECOND SCHEDULE

(Section 49 (1))

purposes for which Pharmaceutica ls , e tc., may not be Advertised.1. The cure of syphilis , gonorrhea or soft chancre in any of the ir forms .2. The prevention, re lie f or cure of Bright's disease , schis tosomias is or bilbarzia .

ankylos tomias is or hookworm, cancer, consumption or tuberculos is , leprosy. lupus-diabe tes , epilepsy or fits , locomotor a taxy, para lys is , or infantile Para lys is .

3. The cure of a rte rio-scle ros is , septicemia , diphtheria , dripsy, e rys ipe las , ga lls toneskidney s tones and bladder s tones , goite r, heart disease , te tanus or lockjaw, pleurisy.pneumonia , scarle t-fever, smallpox, trachoma, amenorrhea , hernia or rupture .blindness , or any s tructura l or organic a ilment of the auditory sys tem.

4. The cure of any habit associa ted with sexua l indulgence , or of any a ilmentassocia ted with those habits ; or the res tora tion or s timula tion of the sexua l functions .

THIRD SCHEDULE

(Section 59 M)

CERTIFICATE OF ANALYSIS

The Pharmaceutica ls and Poisons Act, 1978

Section 59 (1)

To:

I,..............................., be ing the Government Analys is for thepurposes of the Pharmaceutica ls and Poisons Act. 1978, do hereby certify tha t I rece ived

19day ofon thefrom a sca led Packe t marked

and sa id to conta in a sample of 0tha t I found sea ls intact and have ana lysed & contents of tha t packe t, andhereby decla re tha t the result of my ana lys is was as follows:-

I am of the opinion tha t the sample conta ined parts as under or the fore ign ingre-dient as follows:-

Observations

As witness my hand this 19day ofS ignature

Government Chemis t (or as thecase may be)

Note :- All percentages given in definitions or s tandards prescribed a re . unless otherwisespecified, percentages by weight.

Passed in the Nationa l Assembly on the fourteenth day of April,

1978.

Printed by the Government printe r, Dar es Sa laam Tanzania

MMwinda d i

Ag. Clerk of the National Assembly

Documents

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