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COSMETICS AND MEDICAL DEVICES (ADVERTISEMENT) REGULATIONS

ARRANGEMENT OF REGULATIONS

REGULATION

1. Application of these Regulations.

2. Restriction on the product.

3. Application for the approval of advertisement.

4. Particulars of application.

5. Agency may grant an approval.

6. Validity of approval.

7. Alteration in approved script.

8. Nature of advertisement.

9. Unacceptable advertisement.

10. Withdrawal of an approval.

11. Appeal in case of withdrawal of approval.

12. Prohibition of reference to member of health care profession, etc.

13. Contravention of ethical standards not permitted.

14. Advertisement not to prejudice public confidence.

15. Unfairly disparage competition.

16. Prohibition of imitation or misleading advertisement.

17. Exploitation of superstitious belief.

18. Restriction.

19. Prohibition of misleading comparison.

20. Accurate interpretation of research findings.

21. Scientific articles and literatures to contain both positive features and negative findings.

22. Offence.

23. Interpretation.

24. Citation.

COSMETICS AND MEDICAL DEVICES (ADVERTISEMENT) REGULATIONS

[S.I. 17 of 1996.]

under sections 5 and 29

[2nd January, 1996]

[Commencement.]

1. Application of these Regulations

These Regulations apply to all advertisements and promotion of cosmetics and medical devices (in these Regulations referred to individually as “the product”) (whether single entity or compound) imported into Nigeria or manufactured, distributed or sold in Nigeria.

2. Restriction on the product

No person shall advertise the product unless-

(a) the product has been registered by the National Agency for Food and Drug Administration and Control (in these Regulations referred to as the “Agency”);

(b) the advertisement has been cleared and approved by the Agency.

3. Application for the approval of advertisement

An application for the approval of an advertisement shall be made by an advertisement agent, a distributor, manufacturer or the sponsor of the advertisement, through the State office of the Agency, to the Director-General of the Agency.

4. Particulars of application

(1) The application shall contain the following information, where applicable, that is-

(a) the brand name of the product;

(b) the generic name of the product;

(c) the dosage form of the product, if available;

(d) whether the product is imported or manufactured in Nigeria;

(e) the name and address of the manufacturer of the product;

(f) the name and address of the distributor of the product;

(g) the name and address of the advertising company;

(h) the date of first introduction of the product to the Nigerian market;

(i) any information on any previous advertisement of the product in Nigeria,

if any;

(j) if any previous advertisement in Nigeria, a copy of that advertisement;

(k) the proposed media for the advertisement;

(I) a copy of the registration certificate of the product;

(m) justification for any special claims.

(2) The scripts and story-board art works, radio and video tapes of the advertisement shall be submitted with the application.

(3) All materials submitted under this Regulation shall be authenticated by the superintendent pharmacist of the pharmaceutical company and the Chief Executive of the cosmetics or medical devices company sponsoring the product.

5. Agency may grant an approval

Where the Agency is satisfied that there is need for an approval to be granted, it shall do so and issue to the applicant a certificate of approval, subject to such conditions as the Agency may deem necessary.

6. Validity of approval

An approval shall be valid for a period of one year from the date of the approval and may be renewed.

7. Alteration in approved script

Any alteration in the format of the approved script, art work or story-board without the written permission of the Agency shall render the approval null and void.

8. Nature of advertisement

An advertisement shall be accurate, complete, clear and designed to promote credibility and trust by the general public and health care practitioners, and accordingly, no illustration which is likely to mislead the general public either directly or by implication shall be accepted.

9. Unacceptable advertisement

Where an advertisement is considered unacceptable by the Agency, the words “Unacceptable as presented” shall be stamped on it and returned to the applicant with the unacceptable information or illustration clearly identified, and further clarification of the ruling shall be provided on request by the applicant.

10. Withdrawal of an approval

The Agency may withdraw the approval for an advertisement if-

(a) the grounds on which the approval was granted was later found to be false or incomplete; or

(b) any of the conditions under which the approval was granted has been contravened; or

(c) the standard of the advertisement contravenes the provisions of regulation 13, 14, 15, 16, 17, 18, 19,20 or 21 of these Regulations.

11. Appeal in case of withdrawal of approval

(1) Where the approval for an advertisement is withdrawn during its validity, an appeal may be directed to the Agency within 30 days of the withdrawal.

(2) An appeal under paragraph (1) of this regulation shall be in writing and be accompanied with such materials and other information as may be necessary to support the appeal.

12. Prohibition of reference to member of health care profession, etc.

No advertisement shall make reference directly or indirectly to any member of the healthcare profession or to a hospital, clinic or any other health centre.

13. Contravention of ethical standards not permitted

No advertisement shall contravene the ethical standard of the health care profession.

14. Advertisement not to prejudice public confidence

No advertisement shall bring the pharmaceutical industry into disrepute, undermine or prejudice public confidence in medicine.

15. Unfairly disparage competition

No advertisement shall unfairly disparage any competitive company of its competitive products either directly or by implication.

16. Prohibition of imitation or misleading advertisement

No advertisement shall imitate the general layout, text, slogan or visual presentation of any other competing product in a way likely to mislead or confuse the consumer.

17. Exploitation of superstitious belief

No advertisement shall be framed in a manner as to exploit any superstitions or be calculated to induce fear, causing the public to purchase the product advertised.

18. Restriction

No advertisement shall contain-

(a) any false or misleading information; or

(b) half-truth, inadequate qualification and limitation regarding the safety or effectiveness of the product; or

(c) vague or unsubstantiated statement or suggestion or superiority over competing product; or

(d) any false impression that the product advertised is more effective or safer than any other competing product.

19. Prohibition of misleading comparison

(1) No comparison in an advertisement shall mislead the public either directly or by implication and where there is comparison it shall be supported by reliable current data.

(2) A reference to a competitive manufacturer or its specialties in an advertisement shall be restricted to factual comparison without the use of identifiable regulated product or product or brand name.

(3) A data illustration, including chart and graph, table extracted from reference study or other source or reproduced by art work, presented in an advertisement, shall-

(a) be accurate, complete and clear, with their source specifically identified;

(b) not be misleading or ambiguous or distort the original intended meaning or interpretation either directly or by implication.

20. Accurate interpretation of research findings

(1) A copy of an advertisement shall be so written as to accurately interpret valid and representative research findings.

(2) Statistics in an advertisement shall be so written as to reflect only their true validity and significance.

(3) Any claim or quotation from a scientific literature concerning the efficacy, safety and adverse reaction, use in young children or during pregnancy or in any other situation with the constraints of the accepted products monograph, shall specify the scientific source of the claim or quotation.

(4) Copy of any reference cited by an applicant or in the advertisement shall be provided to the Agency for verification.

21. Scientific articles and literatures to contain both positive features and negative findings

(1) A claim or quotation shall contain both the negative and positive findings and shall be readily verifiable by the Agency.

(2) A claim based on, or quotation that has been selected from a scientific article or series of articles which emphasises only the positive features while ignoring negative findings, shall not be acceptable.

22. Offence

A person who contravenes a provision of these Regulations is guilty of an offence and liable on conviction to a fine ofN50,000.

23. Interpretation

(1) In these Regulations, unless the context otherwise requires-

Act” means the National Agency for Food and Drug Administration and Control Act 1993;

[1993 No. 15.]

advertising” means the publicity of goods and description of all products (which includes any form of notices in circulars, handouts, labels, wrappers, catalogues and price lists, bill boards, posters, newspapers, magazines, and any other documents) made orally or otherwise or by means of projected light and sound recordings;

Agency” means the National Agency for Food and Drug Administration and Control established under the Act;

claim” means any representation which states, suggests or implies that the medical device has particular qualities relating to its origin, nature, processing, composition or any other quality;

cosmetic” has the meaning assigned to it in the Drugs and Related Products (Registration, etc.) Act 1993;

[1993 No. 19.]

Director-General” means the Director-General of the National Agency for Food and Drug Administration and Control;

justification” in respect of any claim shall be in the light of current knowledge;

label” means a display of written, printed or graphic matter upon the immediate medical device containers;

package labelling” includes the label on the immediate container plus all other printed matter such as outer wrapper, carton or leaflet associated with the package;

medical device” has the meaning assigned to it in the Act;

product” means any cosmetic or medical device.

(2) Any word or expression used in these Regulations shall, unless the context otherwise requires, have the meaning assigned to it in the Act.

24. Citation

These Regulations may be cited as the Cosmetics and Medical Devices (Advertisement) Regulations.

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