«back to Laws and Treaties

DRUG PRODUCTS ADVERTISEMENT REGULATIONS

ARRANGEMENT OF REGULATIONS

     REGULATION

1. Advertisement of registered product only.

2. Clearance to be obtained before advertisement.

3. Nature of advertisement.

4. Non-referential advertisement.

5. Application for the approval of advertisement.

6. Particulars of application.

7. Validity of approval.

8. Alteration in approved script.

9. Unacceptable advertisement.

10. Appeal in case of withdrawal of approval within the one year specified.

11. Advertisement to effect caution in drug usage.

12. Drug advertisement not to state that a product is “safe”, “non-toxic”, etc.

13. Restriction.

14. Labelling advertisement. Prescription drugs and particulars of prescription.

15. Data comparison misrepresentation.

16. Side effect and contra-indications.

17. Contents of advertisements with specific therapeutic claims.

18. Accurate interpretation of research findings.

19. Claims and quotations from scientific literature to be mentioned.

20. Scientific articles and literature to contain both positive features and negative

findings.

21. Restriction or selection of quotation.

22. Prohibition of advertisement for certain diseases.

23. Labelling particulars and information for over-the-counter drugs.

24.Labelling of over-the-counter drugs.

25.Advertisement to contain certain information.

26. Restriction on use of advertisement.

27. Advertisement of over-the-counter drugs in mass media.

28. Interpretation.

29. Citation.

SCHEDULE

_____________

DRUG PRODUCTS ADVERTISEMENT REGULATIONS

[S.1. 15 of 1995.]

under sections 5 and 29

[16th August, 1995]

[Commencement ]

1. Advertisement of registered product only

(1) These Regulations apply to all advertisements or promotion of drug products (both single entity and compound) imported into Nigeria or locally manufactured, distributed or sold in Nigeria.

(2) No person shall advertise any drug product unless it has been registered by the Agency.

……………………………….

2. Clearance to be obtained before advertisement

No person shall advertise any drug product unless the advertisement has the pre-clearance and approval of the Agency.

……………………………….

3. Nature of advertisement

The advertisement in Nigeria of any drug product shall be accurate, complete, clear and designed to promote credibility and trust by the general public and health care practitioners, therefore statements or illustrations shall not mislead directly or by implication.

……………………………….

4. Non-referential advertisement

No advertisement of a drug product shall-

(a) imitate the general layout, text, slogan or visual presentation of another drug product in a way likely to mislead or confuse the consumer; or

(b) be framed in such a manner as to exploit any superstitions or be calculated to induce fear among consumers causing them to purchase the drug product being advertised.

……………………………….

5. Application for the approval of advertisement

(1) All advertisement materials including scripts, story-boards, art work, radio, video tapes, etc., shall be submitted under confidential cover along with an application, to the Director-General of the Agency.

(2) Where advertisement materials are submitted through any of the State offices of the Agency, it shall still be subject to the approval of the Director-General of the Agency.

……………………………….

6. Particulars of application

(1) An application submitted by an advertisement agent, distributor, manufacturer or the sponsor of the advert shall contain the following information-

(a) the brand name of the drug;

(b) the generic name of drug;

(c) the dosage form available where applicable;

(d) the place of importation or local manufacturer;

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

(f) the name and location address of the local distributor;

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

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

(i) any previous advertisement of the drug in Nigeria;

(j) a copy of the old script (if any);

(k) the proposed media for the advertisement;

(l) a copy of the registration certificate of the drug;

(m) a copy of the registration certificate of the premises of the sponsors;

(n) scripts, art works, radio, video tapes and story-board of the advert; and

(o) justification for any special claims on the drug.

(2) The advertisement materials on the drug shall be authenticated by the superintendent pharmacist of the pharmaceutical company and the chief executive of the drug company sponsoring the drug.

……………………………….

7. Validity of approval

The approval of an advert shall be valid for a period of one year beginning from the date of the approval.

……………………………….

8. Alteration in approved script

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

……………………………….

9. Unacceptable advertisement

Where an advertisement is considered unacceptable by the Agency the words “Unacceptable as presented” shall be stamped on it and it shall be returned to the advertiser with the unacceptable information or illustration clearly identified.

……………………………….

10. Appeal in case of withdrawal of approval within the one year specified

If the approval of an advertisement is withdrawn during the one year period of approval, an appeal shall be lodged within thirty days after the receipt of the withdrawal to the Governing Council of the Agency in writing and accompanied by supportive information.

……………………………….

11. Advertisement to effect caution in drug usage

Drug advertisements shall reflect an overall attitude of the caution in respect to the drug usage with emphasis on national drug therapy and shall also provide sufficient and balanced information to permit assessment of risk or benefit.

……………………………….

12. Drug advertisement not to state that a product is “safe”, “non-toxic”, etc.

(1) No advertisement for over the counter drugs shall state or imply in absolute terms or by quotations taken out of context, that any pharmaceutical product is “safe” or has “guaranteed efficacy” or special status.

(2) Any statement claiming or implying a superlative function such as “most effective“, “least toxic“, “least tolerated“, or special status such as “the drug of choice“, etc., for a product shall not be used unless it can be adequately substantiated.

……………………………….

13. Restriction

No advertisement for any drug product shall contain-

(a) any false or misleading information;

(b) half-truths, inadequate qualification and limitations regarding safety or

effectiveness of the drug;

(c) vague, unsubstantiated statements, or suggestions of superiority over other

competing drugs; or

(d) any false impression that the advertised drug is for universal cure or should be regarded as a more effective and safer alternative to other related drugs.

……………………………….

Prescription drugs

14. Labelling advertisement. Prescription drugs and particulars of prescription

(1) No person shall advertise any prescription drug to the public and the drug shall be properly labelled with the following information on the package label-

(a) the name of the pharmaceutical product, the brand name or chemical names whichever is applicable;

(b) a quantitative listing of all the ingredients of the drug;

(c) indication for which the drug is intended;

(d) an accurate statement of dosage (per tablets, capsule, etc.);

(e) the daily dose;

(f) the frequency of administration;

(g) the preparation for use (shaking, dilution, refrigeration, etc.);

(h) the expiry date, date of manufacture, storage temperature requirement and lot or batch;

(i) the route or method of administration; adequate warning, where necessary, for the protection of the patient as provided in the drug labelling

guidelines;

(k) the name and location address of manufacturer or packer; and

(l) if an imported drug, the name and address of the local packer or distributor shall appear on the label in such a manner as to identify the connection between the manufacturer and the local packer or distributor such as “manufactured for” …………”distributed by”……………………

(2) Prescribing information shall be legibly presented in a type face not smaller than six points and shall provide good contrast on the packaging.

(3) The indications for use of any therapeutic agent shall conform to the product monograph and label indication approved by the Agency.

(4) The main advertising message and the prescribing information shall be adjoining or page referenced in such a manner as to be liable to be read at the same time one after the other.

(5) All labelling information shall be in English language.

15. Data comparison misrepresentation

(1) No comparison on a drug packaging shall mislead directly or by implication and any such comparison shall be supported by reliable current data.

(2) Any reference to a competitive manufacturer or their specialities shall be restricted to factual comparisons without the use of identifiable products or brand names.

(3) All data illustrations presented in the advertisement including charts, graphs, tables, etc., extracted from reference studies or other sources or reproduced by art work shall be accurate, complete and clear with their source specifically identified.

(4) Data illustrations shall not be misleading or ambiguous or distort the originally intended meaning or interpretation either directly or by implication.

……………………………….

16. Side effect and contra-indications

(1) Advertisement for all drugs shall present information that is reasonably balanced, between indications, effectiveness, safety, side effects and contra-indications.

(2) Advertisement of all drugs for use during pregnancy shall state any known effects of the drug on a pregnant woman, foetus and lactation.

……………………………….

17. Contents of advertisements with specific therapeutic claims

Advertisement of drugs which contain specific therapeutic claims shall contain within the advertisement –

(a) the brand name and non-proprietary or general names of the pharmaceutical product;

(b) the therapeutic classification of the pharmaceutical product;

(c) a quantitative list of the actual medical ingredients contained in each dose or unit;

(d) the indication for use;

(e) the recommended dosage, methods of use and routes of administration for

all stated indications;

(f) a list of adverse reactions (with some indication or expected incidence if known) the precaution to be taken by any member of the health profession and the contra-indications and warning of the pharmaceutical product;

(g) a statement that the product monograph or full prescribing information is readily available from a stated Nigerian address; and

(h) the full name and location address of manufacturer and the Nigerian packer.

……………………………….

18. Accurate interpretation of research findings

A copy of an advertisement shall be written in a manner which accurately interprets valid and representative research findings, also statistics shall be written in a manner which reflects only their true validity and significance.

……………………………….

19. Claims and quotations from scientific literature to be mentioned

(1) Claims and quotations from the scientific literature concerning the efficacy, safety and adverse reactions, use in very young children, use in pregnancy, etc., with the constraints of the accepted products monograph, shall specify the scientific source( s) of information.

(2) Copies of all references cited shall be submitted to the Agency for verification.

……………………………….

20. Scientific articles and literature to contain both positive features and negative findings

(1) Claims based on, or quotations that have been selected from a scientific article or series of articles which emphasise only the positive features other than negative findings of the drug, shall not be acceptable.

(2) Accordingly all claims and quotations shall contain both negative and positive findings and shall be verifiable by the Agency or its representative(s).

……………………………….

21. Restriction or selection of quotation

No selected quotation shall refer to another brand of the same pharmaceutical entity, or to a different formulation of the same active ingredients unless data of accepted methodology are available to warrant “cross reference” between the drugs.

……………………………….

22. Prohibition of advertisement for certain diseases

No person shall advertise a drug as a treatment, prevention or cure for any disease, disorder or abnormal physical state as specified in the Schedule to these Regulations.

……………………………….

Over-the-counter drugs

23. Labelling particulars and information for over-the-counter drugs

The advertisement of an over-the-counter drug in Nigeria shall be properly labelled with the following information included on the package-

(a) the generic and brand if applicable (names of the drug);

(b) the generic and brand (if applicable) names shall be conspicuously placed one above the other with a prefix “Brand” of in between (where

necessary);

(c) a quantitative list of the ingredients of the drug;

(d) the conditions, purpose of or use of the drug;

(e) an accurate statement of the dosage strength (per tablet, capsule, teaspoon, etc.);

(f) the daily dose;

(g) the route or method of administration;

(h) the preparation for use (shaking, dilution, refrigeration, etc.);

(i) adequate warnings, when necessary for the protection of users such as

“keep out of the reach of children”;

(j) the name and location address of manufacturer or packer;

(k) if an imported drug, the name and location address of the local packer or distributor shall appear on the label in such a manner as to identify the connection between the manufacturer and the local packer or distributor such as “manufactured for…………….. distributed by………………”; and

(l) the date of manufacture, date of expiration, unless exempted, storage temperature and batch or lot number.

……………………………….

24. Labelling of over-the-counter drugs

(1) Over-the-counter drugs shall carry package leaflets with complete label information in addition to the contra-indications and the labelling shall not contain any statement which is false, misleading or exaggerated as to amount to a misrepresentation.

(2) Where the bottle, jar or other “immediate container” of the drug has an outer wrapper or carton, such outer wrapper or carton shall bear all the information required to be specified on the label.

(3) All labelling information shall be in English language.

……………………………….

25. Advertisement to contain certain information

The advertisement of a drug which shall not carry any false or misleading information shall contain the following information-

(a) the name of the drug;

(b) the pack size(s) being promoted and their corresponding prices;

(c) the different forms in which the drug is available (if necessary); and

(d) the name and location address of the sellers and manufacturer.

……………………………….

26. Restriction on use of advertisement

No over-the-counter drugs advertisement shall-

(a) contain such words as “magic“, “miracle“, or an exotic description such as “upper potency” or such other words as to induce the daily or continuous use of the drug;

(b) imply that if the reader, viewer or listener is suffering from any ailment or disease he shall suffer more severely from the illness, ailment or disease on failure to use that particular drug;

(c) over dramatise any symptoms by way of drawing a picture of a pregnant woman, patient with backache, or use throbbing sounds like heartbeats, coughing or agonising cries; and

(d) denigrate or attack unfairly any competitive products, goods or services.

……………………………….

27. Advertisement of over-the-counter drugs in mass media

No person shall advertise any drug unless such advertisement states clearly both the generic and brand (if applicable) names of the drug.

……………………………….

28. Interpretation

In these Regulations, unless the context otherwise requires-

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;

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

Director-General” means the Director-General of the Agency;

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

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

location address” means a place where the business of manufacture, sale, distribution, storage and display of pharmaceutical products is carried out which includes the house number, plot number, street name, town or city, state, country, etc.;

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

prescription drug” means a drug which can only be made available to a patient through a written prescription signed by a duly qualified and registered medical practitioner and dispensed by a registered and licensed pharmacist; such drug shall not be made available or sold directly to the general public without the said prescription and shall be identified by chemical or generic name(s);

pharmaceutical product” means a substance or mixture of substances manufactured, sold or prescribed for invivo use in the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state of the symptoms thereof, or in restoring, correcting or modifying organic function in man or animals but excluding mechanical devices and cosmetics;

rational drug therapy” means appropriate therapy recommended or prescribed which logically may be expected to remedy or ameliorate a disordered state of physical or mental health, and shall include logical use for a diagnostic and prophylactic purpose to prevent or lower the incidence of illness;

therapeutic classification of pharmaceutical product” means either the accepted pharmacological classification (e.g. anxiolytic, diuretic, analgestic, antibiotic, etc.) or the identity of the purpose(s) for which the pharmaceutical product is intended (migraine, hypertension, etc.,) or both.

……………………………….

29. Citation

These Regulations may be cited as the Drug Products Advertisement Regulations.

_________________

Schedule

[Regulation 22.]

Alcoholism

Appendicitis

Arteriosclerosis

Asthma

Blood disorders

Cancer

Cataract

Cholera

Diabetes

Diphtheria

Disorders of menstrual flow

Disorders of prostate gland

Dysentery

Encephalitis

Enteric fever

Epilepsy

Erysipelas

Filariasias

Gallstones, kidney stones and bladder stones

Gangrene

Any genital or urinary diseases not mentioned elsewhere in the Schedule Glaucoma

Goitre

Hay fever

Heart disease

Hernia

High blood pressure Infective hepatitis Influenza and flu

Jaundice

Kidney disease

Leprosy

Locomotor ataxis

Loss of youth

Measles

Meningitis

Mental conditions

Mumps

Nervousness

Nutritional disorders

Obesity

Onchocerciasis

Paralysis

Plague

Pleurisy

Pneumonia

Poliomyelitis

Rabies

Rheumatic fever

Schistosomiasis

Sexual impotence, loss of virility or sterility Sleeping sickness

Small pox

Snake bite

Syphilis

Tetanus

Trachoma

Tuberculosis

Tumours

Typhoid fever

Undulant fever

Ulcers of the gastro-intestinal tract

Venereal diseases

Yaws

Yellow fever

NLIPW

Print Friendly, PDF & Email
FILE A TRADEMARK

1 Trackback / Pingback

  1. Nigeria's Advertising Laws, Regulations and Guidelines | IP Laws

Comments are closed.