Point in Time
Act No: CAP. 244
Act Title: PHARMACY AND POISONS
[ Date of commencement: 1st May, 1957. ]
[ Date of assent: 11th May, 1956. ]
Arrangement of Sections
PART I – PRELIMINARY
1.
Short title

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

3A.
Powers of the Board

The Board may—

(a)

formulate guidelines for regulating the manufacture, import and export, distribution, sale and use of medical products;

(b)

grant or withdraw authorization for conducting clinical trials of medical products;

(c)

grant or withdraw marketing authorization for medical products subject to appropriate conditions and revise such conditions for marketing authorization as necessary;

(d)

recall medical products from the market;

(e)

grant or withdraw licenses to manufacturers, wholesalers, retailers, importers, exporters and distributors;

(f)

investigate conduct related to the manufacture, import, export storage, distribution, sale and use of medical products;

(g)

levy, collect and utilize fees for services rendered;

(h)

prescribe the standards appropriate for new medical products; new uses, dosages, and formulations of existing medical products; and such other categories as may be appropriate;

(i)

constitute technical and expert advisory committees;

(j)

institute administrative, civil and criminal proceedings;

(k)

exercise such other powers as necessary for the performance of its functions.

[Act No. 5 of 2019, Sch.]

3B.
Functions of the Board
(1)

The Board shall be responsible for the regulation of health products, technologies and the profession of pharmacy.

(2)

The Board shall perform the following functions in relation to regulation of health products and technologies—

(a)

advise the national and county governments in all matters relating to the safety, packaging and distribution of medicines;

(b)

ensure that all medicinal products manufactured in, imported into or exported from the country conform to prescribed standards of quality safety and efficacy;

(c)

ensure that the personnel, premises and practices employed in the manufacture, storage, marketing, distribution and sale of medicinal substances comply with the defined codes of practice and other prescribed requirements;

(d)

enforce the prescribed standards of quality, safety and efficacy of all medicinal substances manufactured, imported into or exported out of the country;

(e)

grant or revoke licenses for the manufacture, importation, exportation, distribution and sale of medicinal substances;

(f)

maintain a register of all authorized medicinal substances;

(g)

publish, at least once in every three months, lists of authorized or registered medicinal substances and of products with marketing authorizations;

(h)

regulate licit use of narcotic, psychotropic substances and precursor chemical substances in accordance with either the Single Convention on Narcotic Drugs of 1961, the Convention on Psychotropic Substances 1971, and the UN Convention against Illicit Traffic Drug and Psychotropic Substances, 1988;

(i)

consider applications for approval and alterations of dossiers intended for use in marketing authorization of medicinal substances;

(j)

inspect and license all manufacturing premises, importing and exporting agents, wholesalers, distributors, pharmacies, including those in hospitals and clinics, and other retail outlets;

(k)

prescribe a system for sampling, analysis and other testing procedures of finished medicinal products released into the market to ensure compliance with the labeled specifications;

(l)

conduct post-market surveillance of safety and quality of medical products;

(m)

monitor the market for the presence of illegal or counterfeit medicinal substances;

(n)

regulate the promotion, advertising and marketing of medicinal substances in accordance with approved product information;

(o)

approve the use of any unregistered medicinal substance for purposes of clinical trials and compassionate use;

(p)

approve and regulate clinical trials on medicinal substances;

(q)

disseminate information on medical products to health professionals and to the public in order to promote their rational use;

(r)

collaborate with other national, regional and international institutions on medicinal substances regulation;

(s)

advise the Cabinet Secretary on matters relating to control, authorization and registration of medicinal substances; and

(t)

perform any other function relating to regulation of medicinal substances.

(3)

The Board shall perform the following functions in relation to regulation of the profession of pharmacy—

(a)

promote the practice of pharmacy that complies with universally accepted norms and values;

(b)

prescribe the minimum requirements and consider and approve the qualifications of persons wishing to be registered as pharmacists under this Act;

(c)

prescribe the minimum requirements and consider and approve the qualifications of persons wishing to be enrolled as pharmaceutical technologists under this Act;

(d)

maintain a register of all persons registered or enrolled under this Act;

(e)

prescribe and conduct examinations for purposes of recognition, registration or enrolment under this Act;

(f)

establish or prescribe the different categories of pharmacy business and the scope of practice of persons registered or enrolled in terms of this Act, or the services or acts which shall for purposes of this Act be deemed to be services or acts specially pertaining to pharmacists or pharmaceutical technologists, and the conditions under which those services may be provided or the acts which may be performed;

(g)

approve institutions to be established or accredited under the Universities Act, (No. 42 of 2012) training pharmacists, and mid-level institutions training pharmaceutical technologists;

(h)

license the practice of pharmacists and pharmaceutical technologists under this Act;

(i)

approve and license the premises for the practice by pharmacists and pharmaceutical technologists under this Act;

(j)

regulate the professional conduct of pharmacists and pharmaceutical technologists and take such disciplinary measures as may be appropriate to maintain proper professional standards and ethics;

(k)

establish, approve and accredit continuing professional educational programs for pharmacists and pharmaceutical technologists;

(l)

establish and maintain a professional code of conduct for pharmacists and pharmaceutical technologists; and

(m)

perform any other function relating to regulation of the profession of pharmacy.

[Act No. 5 of 2019, Sch.]

PART II – PHARMACY
9B.
Application for practising license

A person wishing to be issued with a practising license under section 9A shall make an application to the Registrar in the prescribed form and such application shall be accompanied by the prescribed fee.

[Act No. 5 of 2019, Sch.]

9C.
Issue of practising license
(1)

Where an application for a practising license is made by a person in accordance with section 9B, the Registrar shall issue a practising license if satisfied that the person—

(a)

is registered under section 6 of this Act;

(b)

has undertaken continuous professional development in the preceding year as prescribed by the Board; and

(c)

meets such other requirements as may be prescribed.

(2)

For the purposes of this Act, a person shall be deemed to engage in the practice of pharmacy if the person—

(a)

engages in, conducts or carries on the dispensing, manufacture, compounding of any drugs or medicines, or offers any form of pharmaceutical care or pharmaceutical services within Kenya; or

(b)

advertises or represents himself or herself by a title, sign, display, declaration, or other item to be a pharmacist or pharmaceutical technologist.

(3)

For purposes of this Act, it shall be a requirement for every practising registered pharmacist and enrolled pharmaceutical technologist, practising in their private capacity, government, faith based institutions, non-governmental organizations, training institutions, research organizations or any other institution, to have a valid practising license.

[Act No. 5 of 2019, Sch.]

9D.
Refusal to issue or renew a license

The Board may deny or refuse to issue or renew a license under this Act if it determines after due process, that the applicant has failed to comply with the requirements of this Act or its rules.

[Act No. 5 of 2019, Sch.]

9E.
Renewal, cancellation and suspension of license
(1)

A registered pharmacist or enrolled pharmaceutical technologist issued with a license under this Act may apply for renewal of the license in the prescribed form at least thirty days before the date of expiry thereof.

(2)

A registered pharmacist or an enrolled pharmaceutical technologist who fails to renew a license within the prescribed period shall, when applying for a renewal, be required to pay such late application fee as shall be prescribed.

[Act No. 5 of 2019, Sch.]

9F.
Continuous professional development

For purposes of maintaining a level of competence in his or her ongoing practice, every registered pharmacist and enrolled pharmaceutical technologist shall undertake appropriate Continuous Professional Development as prescribed by the Board.

[Act No. 5 of 2019, Sch.]

11.
Publication of details of registered pharmacists
(1)

Whenever a name is added to or deleted from the register for any cause the registrar shall without undue delay publish in the Gazette the fact of such the addition or deletion and the reason therefor, together with the name and address of the person concerned.

(2)

The registrar shall, as soon as conveniently may be after the first day of January in every year, publish in the Gazette a list of the names, qualifications and addresses of all registered pharmacists.

12.
Professional misconduct
(1)

Where—

(a)

a person applying to have his name registered; or

(b)

a registered pharmacist or any person employed by him in the carrying on of his business; or

(c)

a person whose name has been deleted from the register or any person employed by him as aforesaid,

has at any time been convicted, whether within or outside Kenya, of any criminal offence or been guilty of any misconduct (being in a case falling within paragraph (c) of this subsection a conviction or misconduct which took place either before or after the deletion of the name) which in the opinion of the Board renders the convicted or guilty person unfit to have his name on the register, the Board may, after inquiring into the matter—

(i) in a case falling within paragraph (a) of this subsection, direct that the applicant’s name shall not be registered, or shall not be registered until the Board otherwise directs;
(ii) in a case falling within paragraph (b) of this subsection, direct the registrar to delete the name of the registered pharmacist from the register;
(iii) in a case falling within paragraph (c) of this subsection, direct that the name removed from the register shall not be restored thereto, or shall not be restored thereto until the Board otherwise directs,

and where the Board directs that a name shall be deleted from the register or shall not until the Board otherwise directs be registered or restored to the register, the Board may also direct that no application to the registrar in respect of its registration, or as the case may be its restoration to the register, shall be entertained thereafter until the expiration of such period as may be specified in the direction or until the fulfilment of such conditions as may be so specified.

(2)

Where the name of any person has been deleted from the register in pursuance of a direction under paragraph (ii) of subsection (1) of this section, the Board may, either of its own motion or on the application of that person, direct the registrar to restore the name to the register, either without fee or on the payment to the registrar of such fee as may be prescribed in the behalf, not exceeding the fee prescribed for registration in pursuance of section 9.

(3)

It shall be the duty of the registrar—

(a)

to give notice of any direction under this section to the person to whom the direction relates;

(b)

to give notice of any refusal of an application made under the last foregoing subsection to the applicant,

and any such notice shall be sent by registered letter which, in the case of a registered pharmacists, shall be addressed to his address on the register.

12A.
Enquiries and Disciplinary Committee
(1)

The Board shall establish an Enquiries and Disciplinary Committee which shall enquire into any matter arising under section 12 of this Act.

(2)

Where on the recommendations of the Enquiries and Disciplinary Committee the Board is satisfied that a pharmacist or pharmaceutical technologist is in breach of any of the terms or conditions of practice prescribed by the Board, the Board may—

(a)

issue the pharmacist or pharmaceutical technologist with a letter of admonishment;

(b)

impose a fine as may be prescribed in regulations;

(c)

suspend the registration or enrolment of the pharmacist or pharmaceutical technologist for a specified period not exceeding five years; or

(d)

remove the name of the pharmacist or pharmaceutical technologist from the Register as may be appropriate.

(3)

The Board may order a pharmacist or pharmaceutical technologist to reimburse costs and expenses incurred in connection with a disciplinary hearing and such costs shall be a civil debt recoverable summarily by the Board.

[Act No. 5 of 2019, Sch.]

13.
Restriction on directions by Board
(1)

Where an act or omission which under subsection (1) of section 12 may be made the ground of a direction by the Board involving the cesser or restriction of the right of a person to have his name registered is an act or omission on the part of an employee of that person, the Board shall not give any such direction unless proof is given to its satisfaction of some one or more of the facts specified in the next subsection and the Board is of the opinion that, having regard to the facts so proved, the said person ought to be regarded as responsible for the act or omission.

(2)

The facts as to some one or more of which the Board must be satisfied before giving any such direction as is mentioned in subsection (1) of this section are—

(a)

that the act or omission in question was instigated or connived at by the said person;

(b)

that the person or any employee of his had been guilty at some time within twelve months before the date on which the act or omission in question took place of a similar act or omission and that the person had, or reasonably ought to have had, knowledge of that previous act or omission;

(c)

if the act or omission in question was a continuing act or omission, that the person had, or reasonably ought to have had, knowledge of the continuance thereof;

(d)

in the case of a criminal offence being an offence under this Act, that the person had not used due diligence to enforce the execution of this Act.

14.
Appeal against direction, etc
(1)

A person aggrieved by a direction of the Board under section 12 of this Act or by the refusal of an application made under subsection (2) of that section may at any time within one month from the date on which notice of the direction or, as the case may be, of the refusal is given to him appeal to the Supreme Court against the direction or refusal, and the Board may appear as respondent in any such appeal.

(2)

The Supreme Court may on any such appeal make such order as it thinks fit in the matter and any order of the Supreme Court on any such appeal shall be final.

(3)

It shall be the duty of the registrar to make such alterations in the register as are necessary to give effect to any such order as aforesaid.

15.
Time of operation of direction for deletion of name

A direction under paragraph (ii) of subsection (1) of section 12 of this Act shall not take effect until the expiration of one month from the giving of notice of the direction as required by subsection (3) of that section or, where an appeal to the Supreme Court is brought against the direction, until the appeal is determined or withdrawn.

16.
Registration or restoration of name where appeal dismissed

If the Supreme Court has dismissed an appeal against a direction under subsection (1) of section 12 of this Act that a name shall be deleted from the register or shall not, until the Board otherwise directs, be registered or restored to the register, a direction by the Board authorizing the registration or restoration of the name shall not take effect unless it is approved by the Cabinet Secretary.

17.
Deletion of name from register for conduct outside Kenya

If by reason of a conviction or of professional misconduct the name of a pharmacist registered in Kenya (whether before or after such conviction or misconduct) is in any other country removed, deleted or struck from the register of pharmacists (by whatever name or style designated) of such country, or if by any order or other process such pharmacist is in any such country disentitled to practise as a pharmacist (by whatever name or style designated), the Board may direct the registrar to delete the name of the pharmacist from the register, but without prejudice to the provisions of subsection (2) of section 12 of this Act.

21.
Bodies corporate
(1)

Notwithstanding anything contained in the foregoing provisions of this Part, it shall not be necessary for a body corporate carrying on the business of a pharmacist to be registered under this Act provided that—

(a)

a copy of the certificate of incorporation of the body corporate is lodged with the Board;

(b)

such business is under the management of a superintendent who is a registered pharmacist and a member of the board of directors of the body corporate, and who is not acting in a similar capacity for any other body corporate;

(c)

in each set of premises where the business is carried on, the business, so far as concerns the retail sale of drugs, is carried on by the superintendent, or, subject to the directions of the superintendent, by a manager or assistant who is a registered pharmacist;

(d)

in each set of premises where the business is carried on, the name and certificate of registration of the person in control of the business is conspicuously displayed.

(2)

Any emblem, description or title which may be used by a registered pharmacist, may be used by a body corporate lawfully carrying on the business of the pharmacist.

22.
Carrying on of business by personal representatives
(1)

Notwithstanding anything in the foregoing provisions of this Part, if a registered pharmacist dies, or becomes of unsound mind or is adjudged bankrupt or enters into an arrangement with his creditors, his representatives may, with the permission of the Board and subject to such directions and conditions as the Board may deem fit to impose, carry on the business, and it shall not be necessary for such representatives to be registered provided that such business is continued only under the personal management and control of a registered pharmacist and for such period not exceeding five years as the Board may decide, and that the provisions of subsection (1) of section 20 of this Act are complied with.

(2)

Any title, emblem or description which may lawfully have been used by the registered pharmacist may continue to be used by his representatives as long as they are authorized by the Board to carry on the business.

(3)

For the purposes of this section an arrangement with creditors means a composition or scheme made in pursuance of the law for the time being in force relating to bankruptcy and includes a deed of arrangement to which the Deeds of Arrangement Act (Cap. 54) applies.

23A.
Power to close premises
(1)

Any premises having been deleted from the register of premises by the Board or any premises which in the Board's opinion have become unsuitable for the carrying on of the business of a pharmacist or pharmaceutical technologist shall be closed.

(2)

The Board shall give the person in charge of the premises at least fourteen days' notice of the intended closure under subsection (1) and the reasons thereof in writing.

(3)

If at the expiry of the period under subsection (2), the Board is not satisfied that the improvements required have been made, an authorized officer shall order closure of the premises

[Act No. 5 of 2019, Sch.]

24.
Authorized seller of poisons

Any person lawfully carrying on the business of a pharmacist in accordance with the provisions of this Part shall be an authorized seller of poisons.

PART III – POISONS
25.
Preparation of Poisons List
(1)

The Board shall prepare and submit to the Cabinet Secretary for his approval a list of the substances which are to be treated as poisons for the purposes of this Act.

(2)

The list to be prepared under this section shall be divided into two parts as follows—

(a)

Part I of the list shall consist of those poisons which, subject to this Act, are not to be sold except by authorized sellers of poisons and by licensed wholesale dealers and dealers in mining, agricultural or horticultural accessories;

(b)

Part II of the list shall consist of those poisons which, subject to the provisions of this Act, are not to be sold except by persons entitled to sell Part I poisons and by persons licensed under the provisions of section 32 of this Act.

(3)

In determining the distribution of poisons as between Part I and Part II of the list, regard shall be had to the desirability of restricting Part II to articles which are in common use, or likely to come into common use, which it is reasonably necessary to include therein if the public are to have adequate facilities for obtaining them.

(4)

The Cabinet Secretary may, by order, confirm the list with or without modification, and may, after consultation with or on the recommendation of the Board, from time to time by order amend or vary the list as he thinks proper.

(5)

The said list as in force for the time being is in this Act referred to as the Poisons List, and for the purposes of this Act the expressions “Part I Poison” and “Part II Poison” mean any of the poisons listed in Part I and Part II respectively of the Poisons List.

25A.
Clinical trials
(1)

A pharmaceutical product shall not be used for clinical trial unless an approval is granted by the Board with the approval of the relevant ethics body.

(2)

Any person who intends to commence a clinical trial on a pharmaceutical product shall make an application to the Board in the prescribed form and the application shall be accompanied by the study protocol in the prescribed format and the prescribed fee.

(3)

The study protocol submitted under subsection (2) shall include a post-trial access program to ensure access of investigational medicinal substances by participants in a trial before grant of marketing authorization by the Board.

(4)

The Board shall prescribe guidelines for evaluation of applications made under subsection (2) to be implemented for accelerated evaluations during emergency situations, epidemics and outbreaks.

(5)

A person granted an approval under section 25A (1) shall put up a robust quality assurance system to ensure that the clinical trial is carried out so as to ensure the integrity of data generated, the safety and well-being of study participants.

(6)

The Board shall carry out inspections of the clinical trials so as to ensure compliance of the clinical trials with the prescribed requirements.

31.
Supply and dispensing of Part I poisons by doctors, hospitals, etc
(1)

A duly qualified medical practitioner, dentist or veterinary surgeon, or a member of the staff of a hospital, dispensary or similar institution who has been authorized so to do by general or special order of the Cabinet Secretary, may supply or dispense a Part I poison for the purpose of medical, dental or veterinary treatment, as the case may be, subject to the following provisions—

(a)

the poison shall be distinctly labelled with the name and address of the person by whom it is supplied or dispensed;

(b)

the following particulars shall within twenty-four hours after the poison has been supplied or dispensed be entered in a book used regularly for the purpose (but which need not be used exclusively for that purpose), and which shall be called the Prescription Book—

(i) the date 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 was given,

and a registered midwife practising domiciliary midwifery may supply or dispense a Part I poison in accordance with the regulations made under the Nurses, Midwives and Health Visitors Act (No. 21 of 1965), if he complies with paragraph (b) of this subsection in relation to the supplying or dispensing of the poison.

(2)

An authorized seller of poisons may supply a Part I poison prescribed and dispensed by himself, and in every case in which he supplies a Part I poison on prescription (whether the prescription has been drawn up by himself or not) shall enter the particulars in his Prescription Book in accordance with this section, but shall not in respect of such supply be required to make any entry in the Poisons Book in accordance with section 30 of this Act.

(3)

Any person to whom subsection (1) of this section apply who supplies or dispenses any Part I poison otherwise than in compliance with these provisions shall be guilty of an offence and liable to a fine not exceeding five thousand shillings or to imprisonment for a term not exceeding one year or to both such fine and such imprisonment.

32.
Licence to sell Part II poisons
(1)

Every person who, not being otherwise empowered so to do, desires to sell Part II poisons may make application for a licence in writing in the manner prescribed to the Board or a person appointed by it in writing for the purpose.

(2)

If the Board or the person appointed by it is satisfied that it is necessary for a licence under this section to be issued or renewed in order that the public may have adequate facilities for obtaining Part II poisons and that the applicant is a fit and proper person to sell the poisons, and that the premises in which this business is to be carried on are suitable, he may, on payment of the fee prescribed, issue or renew the licence.

(3)

A licence granted under this section may be made subject to such conditions and limitations as the Board or the person appointed by it may think fit to impose.

(4)

Every licence granted under this section shall be in the prescribed form and shall expire on the 31st December of the year in which it is granted.

(5)

The Board or the person appointed by it may refuse to issue or renew a licence, or may revoke the licence of any person who in his opinion is for a reason relating either to the person or his premises not fit to be so licensed, and in the event of refusal or revocation an appeal shall lie to the Cabinet Secretary, whose decision shall be final.

(6)

The Registrar shall keep a register in the prescribed form of all licences issued under this section.

PART IIIA – MANUFACTURE OF MEDICINAL SUBSTANCES
35B.
Compliance with good manufacturing practice

Every person who is granted a manufacturing licence under section 35A shall comply with the good manufacturing practices prescribed by the Board.

PART IIIB – NATIONAL QUALITY CONTROL LABORATORY
35C.
Interpretation of Part

In this Part, unless the context otherwise requires—

“Director” means the Director of the National Quality Control Laboratory appointed under section 35H;

“Laboratory” means the National Quality Control Laboratory established under section 35D.

35D.
Establishment of the National Drug Quality Control Laboratory
(1)

There shall be established a National Quality Laboratory which shall be used as a facility for—

(a)

the examination and testing of drugs and any material or substance from or with which and the manner in which drugs may be manufactured, processed or treated and ensuring the quality control of drugs and medicinal substances;

(b)

performing chemical, biological, bio-chemical, physiological and pharmacological analysis and other pharmaceutical evaluation; and

(c)

testing, at the request of the Board and on behalf of the Government, of locally manufactured and imported drugs or medicinal substances with a view to determining whether such drugs or medicinal substances comply with this Act or rules made thereunder.

35E.
Incorporation of the Laboratory

The Laboratory shall be a body corporate with perpetual succession and a common seal and shall have power to sue and be sued in its corporate name and to acquire, hold and dispose of movable and immovable property for its own purposes.

35F.
Board of Management
(1)

There shall be a Board of Management for the Laboratory, which shall consist of nine members to be appointed by the Pharmacy and Poisons Board.

(2)

A member of the Board of Management appointed under subsection (1) shall hold office for three years but shall be eligible for re-appointment.

(3)

A quorum of the Board of Management shall be five members.

(4)

The Board of management shall meet not less than four times each calendar year.

(5)

The Director shall be the secretary of the Board of Management.

(6)

Subject to this subsection, the Board of Management may regulate its own procedure.

35G.
Functions of the Board of Management

The functions of the Board of Management shall be—

(a)

to administer the property and funds of the Laboratory in such manner and for such purposes as shall, in the opinion of the Board of Management, promote its best interests;

(b)

to receive, on behalf of the Laboratory, grants-in-aid, gifts, donations, fees, subscriptions or other moneys and make disbursements therefrom;

(c)

to make regulations governing the appointment, conduct and discipline of employees of the Laboratory;

(d)

in consultation with the Cabinet Secretary, to draw up a scheme of service for employees of the Laboratory;

(e)

to administer the approved terms and conditions of service, including appointments, dismissals, remuneration and retiring benefits of employees of the Laboratory; and

(f)

to appoint such employees upon terms and conditions to be laid down by the Board of Management, after consultation with the Cabinet Secretary, as it considers necessary for the proper and efficient administration of the Laboratory.

35H.
Director
(1)

The Board of Management shall appoint a Director who shall be the chief executive of the Laboratory responsible to the Board of Management for the day to day management of the Laboratory.

(2)

The Director shall hold office on such terms and conditions of service as may be specified in the instrument of his appointment.

35J.
Financial provisions
(1)

The funds to be used for the management of the Laboratory shall consist of all moneys received or recovered under this Part and moneys provided by Parliament.

(2)

The Laboratory may accept gifts, donations, subscriptions, fees and other moneys for the implementation of approved programmes.

(3)

The financial year of the Laboratory shall be the same as the Government financial year.

(4)

The estimates for the expenditure of the Laboratory shall be submitted through the Cabinet Secretary for approval by the Treasury and shall make provisions for—

(a)

the payment of salaries, allowances and all other charges in respect of the employees of the Laboratory;

(b)

the payment of pensions, gratuities and all other charges in respect of retirement benefits payable out of the funds of the Laboratory;

(c)

the procurement, proper maintenance, repair and replacement of equipment and other immovable property of the Laboratory;

(d)

the proper maintenance of the buildings and grounds of the Laboratory;

(e)

the creation of such reserve funds to meet future or contingent liabilities in respect of retiring benefits, insurance or replacement of building, or equipment or in respect of such other matters as the Board of Management may think fit;

(f)

the cost of Board of Management meetings; and

(g)

capital expenditure.

(5)

The Board of Management shall cause to be kept and the Director shall keep all proper books of accounts of the Laboratory.

(6)

The accounts of the Laboratory shall be audited by the Auditor-General (Corporations).

(7)

The disposal of fixed assets by the Board of Management shall be subject to the approval of the Treasury.

35K.
Certificate of analysis
(1)

A certificate of analysis shall be issued and signed by the Director for every analysis done.

(2)

The certificate of analysis issued under subsection (1) shall be in the prescribed form.

PART IV – MISCELLANEOUS PROVISIONS
37.
Prohibition of advertisements as to certain diseases, etc.
(1)

Subject to the provisions of this Act, no person shall take part in the publication of an advertisement referring to a drug, appliance or article of any description in terms which are calculated to imply that such drugs, appliances or articles may be effective for any of the purposes specified in the Schedule to this Act.

(2)

In any proceedings for contravention of the foregoing provisions of this section, it shall be a defence for the person charged to prove that the advertisement to which the proceedings relate was published only so far as was reasonably necessary to bring it to the notice of one or more persons of the following classes—

(a)

members of the National Assembly;

(b)

members of the governing body of a voluntary hospital;

(c)

duly qualified medical practitioners, dentists and veterinary surgeons;

(d)

registered pharmacists, authorized sellers of poisons and licensed wholesale dealers;

(e)

persons carrying on a business which includes the sale or supply of surgical appliances,

or that the said advertisement was so published in connection with an application for a patent submitted to the appropriate authority so far only as was requisite for the purpose of the application.

(3)

The Cabinet Secretary may from time to time, by notice in the Gazette, amend or vary the Schedule to this Act.

38.
Prohibition of advertisements as to abortion

Subject to the provisions of this Act, no person shall take any part in the publication of any advertisement referring to any drug, appliance or article of any description, in terms which are calculated to lead to the use of such drugs, appliance or article for procuring the miscarriage of women.

39.
Prohibition of misleading advertisements

Subject to the provisions of this Act, no person shall take any part in the publications of any advertisement referring to a drug, medicine, medical appliance or similar article in terms which in the opinion of the Board are considered to be extravagant and to bear little or no relation to the pharmacological properties and action of the ingredients or components thereof.