How to register an imported drug with NAFDAC in Nigeria
HOW TO REGISTER AN IMPORTED DRUG WITH NAFDAC IN NIGERIA
Lex Artifex LLP, δικηγορικό γραφείο στη Νιγηρία, has introduced the F&D Helpdesk to assist individuals and companies involved in the manufacturing, distribution, exportation and importation of regulated food and drugs products in meeting the requirements set by Nigeria’s National Agency for Food and Drug Administration and Control (“NAFDAC”). This publication provides insights on how to register an imported drug with NAFDAC in Nigeria.
HOW TO APPLY TO REGISTER AN IMPORTED DRUG WITH NAFDAC IN NIGERIA
Application to register an imported drug product with NAFDAC in Nigeria can be made by the manufacturer or through his agent, appointed through a Πληρεξούσιο ή Contract Manufacturing Agreement (where applicable);
The Power of Attorney is to be notarized in the country of origin by a Notary Public;
The application for registration shall include the name of the manufacturer, generic name, brand name (where applicable), strength, indications and all the required information on the prescribed forms;
A separate application form is to be submitted for each drug product to be registered. In this context, a drug product means a separate drug formulation. Ωστόσο, the application for registration of one dosage form with different strengths shall be made on a separate application form.
1. The manufacturer, in the case of imported drug products (from India and China only), must submit evidence (Manufacturer’s Certificate) that they are licensed to manufacture drugs for sale in the country of origin. Such evidence must be issued by the competent Health Authority in the country of manufacture.
2. There must be evidence that the drug product is manufactured according to Good Manufacturing Practice (GMP).
3. There must be evidence by the competent Health Authority that the sale of the product does not constitute a contravention of the drug laws of that country (δηλ. Certificate of Pharmaceutical Product (COPP) that conforms to WHO format).
· The documents in respect of 1-3 shall be authenticated by the Nigerian Mission in that country. In countries where no Nigerian Embassy or High Commission exists, any other Embassy or High Commission of any Commonwealth or West African country can authenticate same.
4. The applicant shall submit two (2) dossiers made out in accordance with the Agency’s format.
5. Evidence of Trade Mark Approval for brand name from Federal Ministry of Commerce in Nigeria should be submitted.
6. Copy of current Annual Licence to Practice as a Pharmacist for the Superintendent Pharmacist issued by Pharmacists Council of Nigeria should be submitted.
7. Copy of Current Certificate of Registration Retention of Premises issued by Pharmacists Council of Nigeria
8. Comprehensive Certificate of analysis of the batch of product submitted for registration processing shall be submitted.
1. A drug product shall not be manufactured in Nigeria, unless the factory is inspected and Certificate of Recognition is issued by NAFDAC.
2. In the case of an imported new drug substance, there must be evidence that limited local clinical trials have been undertaken, and that such product is registered in the country of origin and also, in at least 2 or more developed countries.
3. No combination drug product shall be registered or considered for registration unless there is proven evidence that such a product has clinical advantage over the single drug available for the same indication(μικρό).
4. The application should indicate the class or type of registration required – whether a prescription only product or Over the Counter.
5. Product found to be of doubtful, little or no therapeutic value shall not be considered for registration.
6. An applicant shall not be allowed to register a formulation in more than one brand name even where different doses of the active ingredient(μικρό) are used.
7. All dosage forms of a particular brand name must contain the same active ingredient(μικρό) or at least the major active ingredient(μικρό)
E.g. A cream – Betamethasone 10mg
A soap – Betamethasone 20mg
1. Labelling shall be informative, clear and accurate.
2. Minimum requirements on the package label in accordance with the drug labeling regulations should be:
ένα) Name of medicine (brand name) where applicable and generic name.
σι) Name and full location address of the manufacturer.
c) Provision for NAFDAC Registration Number on product label.
d) Batch No., Manufacturing date and Expiry date. (e) Dosage form & strength
e) Indications, frequency, route, conditions of administration.
f) Dosage regimen on the package (OTC drugs only if there is no accompanying leaflet insert.
g) Leaflet insert, if prescription product and hospital packs.
h) Net content of product.
i) Quantitative listing of all the active ingredients per unit dose. (k) Adequate warnings where necessary.
3. Where a brand name is used, there MUST be the generic name which should be conspicuous in character, written directly under the brand name e.g.:-
4. Any drug product whose name or package label bears close resemblance to an already registered product or is likely to be mistaken for such registered product, shall not be considered for registration.
5. Any drug product which is labeled in a foreign language shall NOT be considered for registration unless an English translation is included on the label and package insert (where applicable).
All tariffs are as prescribed.
The timeline for product registration from submission of samples up to the issuance of the registration number is hundred (100) work days. Ωστόσο, this depends on satisfactory compliance by the applicant.
IMPORTANT POINTS TO NOTE
1. Registration of a product does not automatically confer Advertising permit. A separate approval by the Agency shall be required if the product is to be advertised.
2. NAFDAC may withdraw the certificate of Registration in the event that the product is advertised without express approval from the Agency.
3. NAFDAC reserves the right to revoke, suspend or vary the certificate during its validity period.
4. Filling an application form or paying for an application form does not confer registration status.
5. Failure to respond promptly (within 30 work days) to queries on enquiries raised on the application, will automatically lead to suspension of further processing of the application.
6. A successful application attracts a Certificate of Registration with a validity period of five (5) χρόνια.