World Intellectual Property Organization

Ghana

Food and Drugs Act, 1992

 

 


Food and Drugs Act. 199

P.N.D.C.L.3058

P.N.D.C.L. 3058 FOOD AND DRUGS ACT, 1992

ARRANGEMENT OF SECTIONS

Foods

SECTION

I. Prohibition against sale of unwholesome food. 2. Food offered as a prize.

3. Deception of consumers.

4. Standards of foods.

5. Prohibition against sale of poor quality food.

6. Manufacture of food under supervision.

6A. Mandatory fortification of salt.

7. Sale of food under unsanitary conditions.

8. Food unfit for human consumption.

9. Penalty and defence.

10. Closure of premises.

Drugs, Cosmetics, Devices and Chemical Substances

11. Prohibited sale of drugs and other chemical substances.

12. Standards for drugs.

13. Prohibition on disposal of chemical substances.

14. Deception of consumers.

15. Prohibited advertisement.

16. Control of manufacture of drugs.

17. Restriction on importation, and manufacture of drugs.

18. Registration of drugs.

19. Quality certificate on imported drugs.

20. Licence for registering drugs.

21. Renewal of registration and licences.

22. Drugs not to be distributed as samples.

23. Clinical trials and tests.

24. Registration of herbal and homeopathic drugs.

25. Registers.

26. Penalties.

Administration 27. Establishment of Food and Drugs Board.

28. Functions of the Board.

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SECTION

29.

Composition of the Board.

30.

Meetings of the Board.

31.

Committees of the Board.

32.

Chief Executive of the Boar

33.

Divisions of the Board.

34.

Other staff of the Board.

General Provisions

35. Inspection of animals by authorised officers.

36. Powers of authorised officers.

37. Forfeiture and disposal of seized articles.

38. Public analysts.

39. Quarterly reports of analysts.

40. Power of the Board to obtain particulars of certain ingredients.

41. Power of the Court to order licence to be cancelled.

42. Penalties.

.

43. Offences by bodies of persons.

44. Certificate of analysis and presumptions.

45. Presumption as to adulteration.

46. Defence in proceedings for sale of food.

47. Regulations.

48. Code of practice.

49. Limitation of action.

50. Effect of law on Manufacturing Industries Act. 51. Interpretation.

SCHEDULES

FIRST SCHEDULE

List of Publications

SECOND SCHEDULE

Diseases for which Advertisement for Treatment, Prevention or Cure are Prohibited

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3058 FOOD AND DRUGS ACT, 19921

AN ACT to provide standards for the sale of food and drugs and for related matters.

Foods

1. Prohibition against sale of unwholesome food

(1) A person commits an offence if that person sells or offers for sale a food (a) that has in or on it a poisonous or harmful substance,

(b) that is unwholesome or unfit for human or animal consumption,

(c) that consists in whole or in part of a filthy, putrid, rotten, decomposed or

diseased substance,

(d) that is adulterated,

(e) that is injurious to health, or

(f) that is not of the nature, substance or quality prescribed by standards.

(2) In determining whether an article of food is injurious to health, regard should be had not only to the probable effect of that article on the health of a person consuming it, but also to the probable cumulative effect of articles of substantially similar composition on the health of a person consuming the article in ordinary quantities.

2. Food offered as a prize

(1) Section I applies to a food intended for human or animal consumption which is

offered as

(a) a prize or a reward in connection with an entertainment to which the public

is admitted whether on payment of money or not, or

(b) a prize or a reward given away for advertisement purposes or in furtherance

of a trade or business, as if the food were exposed for sale by the organizers of the entertainment or the person offering or giving away the food.

(2) In this section "entertainment" includes a public or social gathering, an amusement, exhibition, a performance, sport or game.

(3) For the purposes of this Act, food is adulterated if

(a) a constituent of the food has in whole or in part been omitted or abstracted;

(b) a damage to the food or the poor quality of the food has been concealed in

any manner;

L This Act was issued as the Food and Drugs Law, 1992 (P.N.D.C.L. 3058) made on the 30th day of December,1992 and notified in the Gazette on 16th July, 1993. It came into force on 30th June, 1996.

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(c) (d)

a substance of the food has been substituted wholly or in part;

a substance has been added to, or mixed or packed with the food to increase its bulk or weight or reduce its quality or strength or to make it appear better or of greater value than it is;

it contains an additive not expressly permitted by the Regulations for the food concerned, or is in excess of the quantity permitted;

a constituent of the food exceeds the amount stated on the label or permitted in the Regulations; or

its nature, substance and quality has been affected to its detriment.

(e)

(f)

(g)

3. Deception of consumers

A person who manufacturers, labels, packages, sells or advertises a food in a manner

that is false, misleading or deceptive as regards its character, nature, value, additives, substance, quality, composition, merit or safety, commits an offence.2

4. Standards of foods

Where a standard is prescribed under an enactment for food, a person who manufac-tures, labels, packages, sells or advertises food in a manner that the food is likely to be mistaken for food of the prescribed standard, commits an offence.3

5. Prohibition against sale of poor quality food

(I) A person who sells to the prejudice of a purchaser a food which is not of the nature, substance or quality of the article demanded by the purchaser commits an offence.

(2) It is not a defence to an offence under subsection (I) to plead that the purchaser was not prejudiced because the food was bought for analysis or for a purpose other than for consumption.

6. Manufacture of food under supervision

A person shall not manufacture a food for sale unless the food is manufactured under the supervision of a person with appropriate knowledge and qualification who can ensure the purity and wholesomeness of the food.4

6A. Mandatory fortification of salt

(1) A person shall not

(a) mine salt for human or animal consumption, or

2. Section 3 was replacedby section I of the Food and Drugs (Amendment) Act, 1996 (Act523).

3. The word "manufactures" was inserted by section 2 of the Food and Drugs (Amendment) Act, 1996 (Act523).

4. The words "licensed under the Manufacturing Industries Act, 1971 (Act 356)" were deleted by section 3 of the Food and Drugs (Amendment) Act, 1996 (Act 523).

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(b) import, manufacture, package, label, advertise, store, deliver, distribute,

trade, sell or export salt,

that is not fortified with potassium iodate in accordance with this Act.

(2) Salt is fortified where it has additives such as potassium iodate, protein, essential amino acids, vitamins, minerals, essential fatty acids or any other nutritional substance added to it to enhance its nutritional value.

(3) The Ghana Standards Board shall determine and publish in the Gazette and news

papers nationwide the standard for the fortification of salt under this Act.

(4) A person shall not label, package, or sell or advertise salt in a manner that is

likely to be mistaken for salt of the prescribed standard.

(5) This section does not apply to salt for industrial or iodation purposes.

(6) Salt for industrial purposes shall be labelled clearly to that effect and stored and

displayed separately from salt intended for human or animal consumption.5

7. Sale of food under unsanitary conditions

(I) A person who sells, prepares, packages, conveys, stores or displays for sale a food

under unsanitary conditions commits an offence.

(2) Food shall be stored and conveyed in a manner that preserves its composition, quality and purity and minimizes the dissipation of its nutritive properties from climatic and any other deteriorating conditions.6

8. Food unfit for human consumption

(1) A person who

(a) sells, or offers or exposes for sale, or has in possession for sale, or

(b) deposits with or consigns to any other person for the purpose of sale,

food intended for, but unfit for, human or animal consumption commits an offence.

(2) Where a food in respect of which an offence under paragraph (a) of subsection (I) has been committed was sold to the person charged by any other person, that other person commits an offence.

(3) Where a person is charged with an offence under paragraph (b) of subsection (I)

or under subsection (2), it is a defence for that person to prove

(a) that notice was given to the person to whom the food was sold, deposited

or consigned that the food in question was not intended for human or animal consumption, or

5. Inserted by section 4 of the Food and Drugs (Amendment) Act, 1996 (Act 523).

6. Subsection (2) was added by section 5 of the Food and Drugs (Amendment) Act, 1996 (Act 523).

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(b)

that, at the time when the food was delivered or dispatched to that person, (i) it was fit for human or animal consumption, or

(ii) that person did not know and could not with reasonable diligence haveascertained that the food was not fit for human or animal con-sumption.

9. Penalty and defence

(I) A person who is found guilty of an offence under section I, 2, 3, 4, 5, 6, 7 or 8 is liable on conviction to a fine not exceeding five hundred penalty units or to a term of

imprisonment, not exceeding two years or to both the fine and the imprisonment and is

liable, in the case of a continuing offence, to a further fine of twenty-five penalty units for

each day during which the offence continues.

(2) In proceedings for an offence under the sections referred to in subsection (I), in respect of a food containing an extraneous matter, unless the presence of the extraneous matter has rendered the food injurious to health, it is a defence for the accused to prove that the presence of that matter was an unavoidable consequence and forms part of the process of preparation or collection of that food.

(3) In proceedings for an offence consisting of the advertisement for sale of a food, it is a defence for the accused to prove that the publication was received and made in the ordinary course of business of the accused as a publisher.

10. Closure of premises

The Minister shall, on the advice of the Board, order the closure of any premises wherefood is manufactured, prepared or sold, if the Board has reason to believe that the food isexposed to the risk of contamination and the Minister may make a further orderappropriate in the circumstances.

11. Prohibited sale of drugs and other chemical substances

Drugs, Cosmetics, Devices and Chemical Substances

A person commits an offence if that person sells a drug, cosmetic, device or chemical substance which

(a)

has in or on it a substance that may cause injury to the health of the user when the article is used

(b)

(i) according to the directions on the label accompanying the article, or

(ii) for a purpose and by a method of use that is customary or usual,

consists in whole or in part of a filthy, rotten, decomposed or diseased sub

stance or of a foreign matter likely to cause injury,

is adulterated, or

is prepared, preserved, packed or stored under unsanitary conditions.

(c) (d)

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12. Standards for drugs

(1) Where a standard is prescribed for a drug, cosmetic, device or chemical substance, a person who labels, packages, sells or advertises any other substance in a manner that is likely to be mistaken for that drug, cosmetic, device or chemical substance commits an offence unless the substance is the drug, cosmetic, device or chemical substance in question and complies with the prescribed standard.

(2) Where a standard is not prescribed for a drug or chemical substance but a standard for the drug or chemical substance is contained in a publication specified in the First Schedule, a person who labels, packages, sells or advertises any other substance or article in a manner that is likely to be mistaken for that drug or chemical substance commits an offence.

(3) A person who labels, packages, sells or advertises a drug or chemical substance for which a standard is not prescribed, or for which a standard is not contained in a publi-cation specified in the First Schedule, commits an offence unless the drug or chemical substance

(a) is in accordance with the professed standard under which it is labelled, sold

or advertised, and

(b)

does not resemble, in a manner likely to deceive, a drug or chemical sub-stance for which a standard has been prescribed or which is contained in a publication specified in the First Schedule.

13. Prohibition on disposal of chemical substances

A person commits an offence if that person uses or disposes of a chemical substance

in a manner likely to cause

(a) contamination of food or water for human or animal consumption, or

(b) injury to, or be dangerous to the health of a person or an animal.

14. Deception of consumers

A person commits an offence if that person labels, packages, sells or advertises a drug, cosmetic, device or chemical substance

(a) (b)

in contravention of a provision of the Regulations, or

in a manner that is false, misleading or deceptive as regards its character,

constitution, value, potency, quality, composition, merits or safety.

15. Prohibited advertisement

A person shall not advertise a drug, cosmetic, device or chemical substance to the general public as a treatment, preventive or cure for a disease, disorder or an abnormal physical state specified in the Second Schedule.

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16. Control of manufacture of drugs

(I) A person shall not manufacture for sale a drug or chemical substance unless,

(a) the process of manufacture is carried on or is supervised by a pharmacist or a person approved by the Board as having specialist knowledge in the article to be manufactured, and

(b) the conditions under which the manufacture is to be carried on are in the

opinion of the Board suitable to ensure that the article will be safe for use.

(2) Applications for approval under subsection (I) shall be made to the Board and

may be granted by the Board subject to the conditions determined by the Board.

(3) Approval under this section shall be granted in consultation with the Minister re-sponsible for Industries.

17. Restriction on importation, and manufacture of drugs

The Minister may, by legislative instrument, prohibit the importation, manufacture, exportation, advertisement or sale of a drug, cosmetic, device or chemical substance specified in the instrument.

18. Registration of drugs

(I) A person shall not manufacture, prepare, sell, supply, export or import a drug, cosmetic, device or chemical substance unless the article has been registered with the Board. .

(2) Subsection (I) does not prevent the importation of samples for purposes of regis-tration of the drug, cosmetic, device or chemical substance.

(3) An application for the registration of a drug, cosmetic, device or chemical sub-stance shall be made to the Board in the form and shall contain the particulars prescribed by the Regulations.

19. Quality certificate on imported drugs

(I) Where a drug, cosmetic, device or chemical substance is imported as a finished

pro

duct, an application for the registration of the drug shall be accompanied by a quality assurance certificate issued by the competent drug control authority of the exporting country .

(2) An application for the registration of a drug, cosmetic, device or chemical sub-stance manufactured in the Republic, shall be accompanied by a certificate of quality issued in respect of it by the Ghana Standards Board.

20. Licence for registering drugs

(I) Where the Food and Drugs Board is satisfied with an application under section 19 it may register the drug, cosmetic, device or chemical substance and issue a licence and number in respect of it for a period of five years or for a lesser period determined by the Board.

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(2) The Board shall suspend or may cancel a licence issued under subsection (1) if an information submitted in respect of the registration changes or is found to have been in-accurate.

(3) An applicant may at any time after suspension or cancellation of a registration re-submit new information on the drug, cosmetic, device or chemical substance.

(4) A person responsible for the registration of a drug, cosmetic, device or chemical substance who fails to inform the Board of a change in the information submitted for its registration commits an offence.

21. Renewal of registration and licences

(1) A registration and licence made or issued under this Act may be renewed.

(2) An application for renewal under subsection (1) shall be accompanied with the prescribed particulars.

22. Drugs not to be distributed as samples

(1) A person who, without authority from the Board, distributes a drug as sample commits an offence.

(2) Subsection (I) does not apply to the distribution of samples of drugs to physicians, dentists, veterinary surgeons, pharmacists, midwives, nurses or medical assistants.

23. Clinical trials and tests

(I) A person shall not in the course of business carried on by that person manufacture, sell, supply or distribute a drug orchemical substance for the purpose of clinical trial test of drugs on animals unless a clinical trial certificate or animal trial certificate has been issued for it by the Board.

(2) A person who carries out a clinical trial test of a new drug on humans or animals in the absence of documentary evidence that human or animal pharmocodynamic and pharmacokinetic studies on health volunteers have been properly carried out, commits an offence.

(3) An application for a clinical trial certificate or an animal trial certificate shall be made to the Board in the prescribed form and may be granted subject to the conditions determined by the Board.

24. Registration of herbal and homeopathic drugs

(1) A person shall not manufacture, prepare, supply, sell, distribute, export or import a herbal medicine or homeopathic drug, unless the herbal medicine or homeopathic drug has been registered with the Board.

(2) The Regulations may prescribe particulars to be provided for the registration of

herbal medicines and homeopathic drugs under subsection (1).

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25. Registers

The Board shall keep separate registers for the registration of food, human and animal

drugs, herbal medicines, homeopathic drugs, cosmetics, devices and chemical substances.

26. Penalties

A person who is found guilty of an offence under a provision of sections II to 25 for which a penalty has not been specified is liable on conviction to a fine not exceeding five hundred penalty units or to a term of imprisonment not exceeding two years or to both the fine and the imprisonment.

Administration

27. Establishment of Food and Drugs Board

(I) There is hereby established a Food and Drugs Board.

(2) The Board shall operate under the control and supervision of the Minister respon-sible for Health.

28. Functions of the Board

(I) The Board shall advise the Minister on matters relating to the administration and implementation of this Act.

(2) Without prejudice to subsection (I), the Board shall

(a) advise the Minister on measures for the protection of the health of consumers;

(b) in co-operation with the Ghana Standards Board, ensure adequate and effective standards for food and drugs;

(c) monitor through the District Assemblies and any other agencies of State

compliance with this Act;

(d) advise the Minister on the preparation of effective Regulations for the im-plementation of this Act; and

(e) perform the functions assigned to it under this Act.

29. Composition of the Board

(I) The Board consists of

(a) the chairman,

(b) one representative of the Ghana Standards Board,

(c) one representative of the Food Research Institute,

(d) the Director of the Fisheries Commission,

(e) one representative of the Ghana Medical Association,

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(j) the Registrar of the Pharmacy Board,

(g) the head of the Nutrition and Food Science Department, University of

Ghana,

(h) one veterinary surgeon nominated by the Minister responsible for Agriculture,

(i) the Director, Crop Services Department of the Ministry of Agriculture,

(j) one representative of the Environmental Protection Agency,

(k) one practitioner of herbal medicine to be appointed by the President,

(I) the chief executive of the Board,

(m) one representative of the Attorney-General or a lawyer of not less than ten

years standing, and

(n) two other persons one of whom is a woman representing consumer interest.

(2) The members of the Board shall be appointed by the President in consultation

with the Council of State. 7

(3) The professional specialists on the Board shall not be appointed unless they are

persons in active practice in their professions.

(4) The members of the Board, other than the ex officio members, shall hold office

for a period of three years but are eligible for re-appointment.

'(5) The validity of the proceedings of the Board shall not be affected by a vacancy

among its members or by the absence of anyone of them.

30. Meetings of the Board

(I) The Board shall meet at least once in every two months at the place and times de-termined by the chairman..

(2) The chairman shall preside at meetings of the Board and in the absence of the

chairman a member elected by the members present shall preside.

(3) Decisions of the Board shall be by a majority of votes and in the event of an equality of votes, the chairman or the person presiding at the meeting shall have a casting vote.

(4) The quorum for a meeting of the Board is seven.

(5) Subject to this section, the Board shall regulate the procedure for its meetings.

31. Committees of the Board

(I) The Board may appoint the committees that it considers necessary, consisting of

members of the Board and non-members.

7. Inserted by section 8 of the Food and Drugs (Amendment) Act, 1996 (Act 523) as subsection (lA).

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(2) Members of a committee appointed by the Board shall be paid the remuneration or allowances determined by the Minister in consultation with the Minister responsible

for Finances

(3) The Board may co-opt a person to act as an advisor but a person so co-opted shall not vote at the meeting on a matter for decision by the Board.

32. Chief Executive of the Board

(I) There shall be a chief executive of the Board who shall be appointed by the Presi

dent in accordance with article 195 of the Constitution.9

(2) The chief executive is a public officer and is responsible for the day-to-day ad-

ministration of the affairs of the Board.

33. Divisions of the Board

(I) The Board shall have two divisions which are the Food Division and the Drugs,

Cosmetics, Devices and Chemical Substances Division.

(2) Each Division shall be headed by a deputy chief executive who shall be appointed

by the President in accordance with article 195 of the Constitution.1O

(3) The deputy chief executives are public officers and are responsible to the chief

executive in the performance of their functions.

34. Other staff of the Board

(I) The Board shall have any other officers and employees as are necessary for the

proper and effective performance of its functions.

(2) The staff of the Board shall perform the functions assigned to them by the chief

executive.

(3) The President shall, in accordance with article 195 of the Constitution, appoint

the staff and employees of the Board.

(4) The President may in accordance with article 195 (2) of the Constitution delegate

the power of appointment of public officers under this Act. I I

8. The words "in consultation with the Minister responsible for Finance" were inserted by section 9 of the

Food and Drugs (Amendment) Act, 1996 (Act 523).

9. Amended by section 10 of the Food and Drugs (Amendment) Act, 1996 (Act 523). 10. Amended by section II of the Food and Drugs (Amendment) Act, 1996 (Act 523).

II. Substituted by subsection 12 of the Food and Drugs (Amendment) Act, 1996 (Act 523).

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General Provisions

35. Inspection of animals by authorised officers

An authorised officer shall, for the purposes of this Act, inspect an animal intended for slaughter and shall seize and examine a meat which the officer considers to be unfit for human consumption.

36. Powers of authorised officers

(I) An authorised officer may at an hour reasonable for the proper performance of a function under this Act,

(a) enter any premises where the officer believes an article to which this Act applies is prepared, preserved, packed, stored or conveyed, and examine the article and take samples and examine anything that the officer believes is used or is capable of being used for the preparation, preservation, pack-aging, storing or conveying of the article;

(b) open and examine a receptacle or package which the officer believes contains an article to which this Act applies;

(c)

examine the books, documents, or any other records found in a place men-tioned in paragraph (a) which the officer believes contains an information relevant to the enforcement of this Act and make copies of them or take ex-tracts from them;

(d) seize and detain for the period that the officerconsiders necessary an article by means of or in relation to which it is believed a provision of this Act has been contravened.

(2) An authorised officer acting under this section shall, if required, produce the authority to act.

(3) An authorised officer may by a warrant break open a container or door of premises where food may be kept for storage or sale; but this power shall be exercised only after the owner or a responsible person in occupation of that premises is present and refuses to open the container or door on being asked to do so.

(4) A person who obstructs or impedes an authorised officer in the course of the officer's

duties or by a gratuity, bribe, promise, or any other inducement prevents, or attempts to

prevent, the due execution by the authorised officer of duties under this Act or the

Regulations, commits of an offence.

37. Forfeiture and disposal of seized articles

(1) Where a person is convicted of an offence under this Act, the Court or tribunal may order the forfeiture of an article by means of or in relation to which the offence was committed or a thing of a similar nature belonging to or in the possession of the convicted person or

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found with the article, and on the order being made the article or thing may be disposed of as directed by the Court or tribunal.

(2) A person who removes, alters or interferes in any way with an article seized under this Act without the authority of an authorised officer commits an offence.

38. Public analysts

(I) The Minister may, on the advice of the Board, and subject to article 195 of the Constitution appoint on the terms determined by the Minister, a public analyst for every district, qualified to undertake the analysis required under this Act.

(2) An authorised officer may submit an article seized by the officer or a sample of it to a public analyst for analysis or examination.

(3) A public analyst shall as soon as practicable analyse or examine a sample sent to the analyst in pursuance of this Act and shall give the authorised officer a certificate specifying the result of the analysis or examination, which certificate shall be in the form prescribed by the Minister after consultation with the Board.

(4) A person shall not be appointed a public analyst for the area where that person is engaged directly or indirectly in a trade or business connected with the sale of drugs, cosmetics, devices or chemical substances.

39. Quarterly reports of analysts

A public analyst shall submit a quarterly report through the District Chief Executive or the Regional Co-ordinating Council to the Board on the number of articles which have been analysed by the analyst under this Act, and the finding of the analysis.

40. Power of the Board to obtain particulars of certain ingredients

(I) The Board may direct a person who, at the date of the directive or at a subsequent time, carries on a business which includes the production,importation or use of articles to which this Act applies to furnish it, within the period specified in the directive, specified particulars on the composition and use of the substance sold or for sale in the course of that business, or used in the preparation of drugs.

(2) Without prejudice to subsection (I), directives made under subsection (I) may re

quire the following particulars to be furnished in respect of the substance:

(a) particulars of the composition and chemical formula of the substance,

(b) particulars of the investigations carried out by, or to the knowledge of, the

persons carrying on the business in question, to determine whether and to what extent the substance used is injurious to, or in any other way affects health, and

(c)

particulars of the investigations or inquiries carried out by or to the knowl-edge of the person carrying on the business in question for the purpose of

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determining the cumulative effect on the health of a person consuming the substance in ordinary quantities.

(3) Particulars furnished in accordance with directives under this section and an information on the particulars shall not be disclosed, without the previous consent in writ-ing of the persons carrying on the business in question, except for the purposes of pro-ceedings for an offence under this Act.

(4) A person who discloses any particulars or an information in contravention of sub-section (3) commits an offence.

41. Power of the Court to order licence to be cancelled

On conviction of a person for an offence under this Act or the Regulations, the Court or tribunal may, in addition to or in lieu of any other penalty which it may impose, sus-pend or cancel a licence issued to that person under this Act or the Regulations.

42. Penalties

(I) A person who commits an offence under this Act for which a special penalty is

not provided is liable on conviction,

(a) in the case of a first offence, to a fine not exceeding two hundred penalty

units or to a term of imprisonment not exceeding six months, or to both the

fine and the imprisonment, or

(b) in the case of a subsequent offence to a fine not exceeding five hundred

penalty units or to a term of imprisonment not exceeding two years or to

both the fine and the imprisonment.

(2) The mining lease of a person holding a mining lease for salt shall be suspended if

that person is convicted twice under this Act. 12

43. Offences by bodies of persons

(I) Where an offence is committed under this Act or under the Regulations by a body

of persons,

(a) in the case of a body corporate, other than a partnership, every director or

officer of that body shall be deemed to have committed that offence, and

(b) in the case of a partnership every partner or officer of that body shall be

deemed to have committed that offence.

12. Inserted by section 13 of the Food and Drugs (Amendment) Act, 1996 (Act 523).

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(2) A person shall not be convicted anoffence by virtue of subsection (I) if it is proved that the offence was committed without the personal knowledge or connivance of,

and that due care and diligence was exercised by that person to prevent the commission

of the offence having regard to the circumstances.

44. Certificate of analysis and presumptions

In proceedings under this Act,

(a) a certificate of analysis signed by a public analyst shall be accepted as

prima facie evidence of the facts stated in it;

(b) evidence that a package containing an article to which this Act applies or the Regulations apply, bore a name, an address or a registered mark of the person by whom it was manufactured or packed is prima facie evidence that the article was manufactured or packed by that person;

(c) a substance commonly used for human or animal consumption shall, if sold, or offered or exposed for sale, be presumed until the contrary is proved, to have been sold or to be intended for sale for human or animal consumption;

(d) a substance commonly used for human or animal consumption which is found on premises used for the preparation or sale of that substance and a substance commonly used in the manufacture of products for human or animal consumption which is found on premises used for the preparation or sale of those products, shall be presumed, until the contrary is proved, to be 'intended for sale, or for manufacturing the products for sale for human or animal consumption.

45. Presumption as to adulteration

Where a person is prosecuted under this Act and it is established that

(a) the article has by regulation been declared to be adulterated if a prescribed

substance has been added to it, and

(b) that person is in possession of or has on the premises of that person the

specified substance,

the burden of proving that the article was not adulterated by the addition of the substance lies on the accused.

46. Defence in proceedings for sale of food

(I) Subject to subsection (2), it is a defence in proceedings for an offence relating to

the sale of an article in breach of a provision of this Act or of the Regulations to prove

(a) that the accused sold the article in the same package and in the same condition as it was when it was bought, and

13. Amended by section 14 of the Food and Drugs (Amendment) Act, 1996 (Act 523).

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(b) that the accused could not with reasonable diligence have ascertained that

the sale of the article would be in breach of this Act or of the Regulations.

(2) An accused person who desires to rely on subsection (I) shall give notice of in-tention to do so at least ten days before the date of the trial and shall disclose to the prosecution the name of the person from whom the article was bought and the date of the purchase.

47. Regulations

The Minister may, after consultation with the Board, by legislative instrument, make

Regulations

(a) specifying what constitutes adulteration of a food or drug;

(b) governing

(i) the treatment, processing and manufacture of food,

(ii) the packaging, labelling, advertising and selling of food,

(iii) the size, dimensions, fill and specifications of packages of food, (iv) the use of a substance as an ingredient in a food, and

(v) the protection of the consumer or purchaser of food from being de-ceived or misled as to its quality, character, composition, merit or safety or to prevent injury to the health of a consumer or purchaser;

(c) for the regulation of importation of food, drugs, cosmetics, devices or

chemical substances in order to ensure compliance with this Act;

(d) prescribing the type and level of food additives;

(e) requiring persons who sell drugs to maintain and keep the prescribed books

of records;

(j) prescribing methods of manufacture, processing, sale, storage and transportation of food, drugs, cosmetics, devices or chemical substances;

(g) for the method of clearance of drugs or chemical substances from the ports;

(h) prohibiting the manufacture, importation, exportation or sale of specified

drugs, devices, cosmetics or chemical substances;

(i)

prescribing forms and particulars to be provided in forms;

(j) amending the Schedules to this Act; and

(k) generally for giving effect to this Act.

48. Code of practice

Despite section 47, the Board may publish codes of practice in connection with mat-ters provided for under this Act for the purpose of giving guidance.

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49. Limitation of action

Prosecution for an offence under this Act or the Regulations shall be commended not

later than six months after the detection of the offence.

50. Effect of law on Manufacturing Industries Act

Repealed.

51. Interpretation

In this Act, unless the context otherwise requires,

"article" means

(a) a food, drug, cosmetic, device or chemical substance,

(b) a thing used for the manufacture, preparation, packaging or storage of food,

drug, cosmetic, device or chemical substance, or

(c) a labelling or an advertising material on food, drug, cosmetic, device or

chemical substance;

"authorised officer" means a medical officer of health, a health inspector or a

person authorised in writing by the Board, the Minister or a District Assembly;

"Board" means the Food and Drugs Board established under section 27;

"chemical substance" means a substance or mixture of substances prepared, sold

or represented for use as

(a)a germicide,

(b) an antiseptic,

(c) a disinfectant,

(d) a pesticide,

(e) an insecticide,

(f) a rodenticide,

(g) a vermicide, or

(h) a detergent, or

any other substance or mixture of substances declared by the Minister, after consulta-tion with the Board, to be a chemical substance;

"cosmetic" includes a substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair, eyes or teeth, and deodorants and perfumes;

14. Repealed by section 15 of the Food and Drugs (Amendment) Act, 1996 (Act 523).

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"device" means an instrument or apparatus including, components, parts and ac-cessories of it, manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the

symptom of it in human or animal;

"drug" includes

(a) a substance included in a publication mentioned in the First Schedule,

(b) a substance or mixture of substances prepared, sold or represented for use

In

(i) the diagnosis, treatment, mitigation or prevention of disease, disorder

or abnormal physical state, or the symptoms of it, in human or animal, or

(ii) restoring, correcting or modifying organic functions in human or animal;

"export" means export out of the Republic;

"food" includes salt and an article manufactured, sold or represented for use as

food or drink for human or animal consumption, chewing gum, water and an ingredient of the food, drink, chewing gum or water;15

"health inspector" means a person lawfully appointed to be a health inspector or a sanitary inspector;

.

"import" means import into the Republic;

"industrial purposes" means the use otherwise than for human or animal

consumption;

"label" includes a legend, work or mark attached to, included in, belonging to or

accompanying a food, drug, cosmetic, device or chemical substance;

"manufacture" with respect to food means the making or composition of a prod-uct, including its production, preparation, processing or preservation in combination

with other components, substances, ingredients or products;17

"Minister" means the Minister responsible for Health;

"package" includes a thing in which a food, drug, cosmetic, device or chemical

substance is wholly or partly placed or packed;

"premises" includes a building, hut, shed, kiosk or tent together with the land on which it is situated and an adjoining land used in connection with it, and a vehicle, conveyance or vessel;

"public analyst" means a person appointed by the Minister to act as an analyst for

the purposes of this Act;

15. Inserted by section 16 of the Food and Drugs (Amendment) Act, 1996 (Act 523). 16. Inserted by section 16 of the Food and Drugs (Amendment) Act, 1996 (Act 523). 17. Inserted by section 16 of the Food and Drugs (Amendment) Act, 1996 (Act 523).

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"Regulations" means Regulations made under this Act;

"selling" includes offering for sale, exposing for sale and having in possession for

sale or distribution;

"unsanitary conditions" means the conditions or circumstances which might contaminate food, drugs or cosmetics with dirt or filth or might render the article inju-rious or dangerous to health.

SCHEDULES

FIRST SCHEDULE

Section 12]

List of Publications

(a) the British Pharmacopoeia;

(b) the Extra Pharmacopoeia;

(c) the United States Pharmcopoeia;

(d) the International Pharmacopoeia.

SECOND SCHEDULE

{Section 15}

Diseases for which Advertisement for Treatment, Prevention or Cure Are Prohibited:

(i) Sexually transmitted diseases, other forms of genito-urinary diseases. Acquired Immune Deficiency Syndrome (AIDS) or diseases connected with the human re-productive functions.

(ii) Any of the following: Amenorrhoea Artetrio-Sc1erosis Bladder Stones Blindness Cancer Deafness Diabetes Diphtheria Dropsy Epilepsy or fits

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SECOND SCHEDULE-continued

Erysipelas Gallstones Goitre

Heart disease

Hernia or rupture

Kidney stones

Leprosy

Locomotortazy

Lupus

Nephritis or Bight’s disease Paralysis

Pleurisy

Pneumonia

Poliomyelitis

Scarlet fever

Septiaemia

Smallpox

Tetanus or lockjaw Trachoma

Tuberculosis or consumption.

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