National Agency for Food and Drug Administration Control (“NAFDAC”) is the body responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, chemicals and packaged water in Nigeria.
Legal Framework
The legislation which regulates the registration of foods and drugs is the National Agency for Food and Drug Administration Control Act, Cap N1, Laws of the Federation, 2004 (“NAFDAC Act”). This Act establishes NAFDAC with a mandate to compile standard specifications and guidelines for the production, importation, exportation, sale and distribution of food, drugs, cosmetics, medical devices, bottled water and chemicals.
Section 5 and 30 of the NAFDAC Act empowers NAFDAC to make Regulations and Guidelines regulating the Registration of food and drugs.
Guidelines for Registration of Foods and Water Manufactured in Nigeria
No food and related products shall be manufactured, imported, exported, advertised, sold or distributed in Nigeria unless it has been registered in accordance with the provisions of the Act and the accompanying guidelines.
A manufacturer who intends to register a food or related product in Nigeria shall first have the factory inspected by the Establishment Inspection Directorate of NAFDAC and be assigned a Certificate of Recognition as a manufacturer before an application to register the product can be made. Three vetting samples shall be submitted upon satisfactory pre- registration inspection.
Documents for Application
The application form shall be completed with a written application for food registration made to the Director, Registration and Regulatory Affairs, stating the name of the manufacturer, the generic name of product, brand name (where applicable).
The Application shall be accompanied by the following documents:
- Evidence of pre-production inspection/ Certificate of Recognition issued by NAFDAC;
- Evidence of Trade mark approval for brand name from Federal Ministry of Commerce (where applicable);
- Certificate of Incorporation of the company issued by the Corporate Affairs Commission.
- Comprehensive Certificate of analysis of the batch of the product submitted for registration from the manufacturer stating name and signature of the analyst.
Upon successful registration, a Certificate of Registration with a validity period of 5 years will be issued. Products with a listing status have a validity of 2 years.
Guideline for Registration of Imported Drug Products in Nigeria
Application Process
- An application for registration of a drug product shall be made by the manufacturer.
- In case of a manufacturer outside Nigeria, the applicant shall be represented in Nigeria by a duly registered pharmaceutical company.
- An applicant for a manufacturer outside Nigeria must file evidence of Power of Attorney from the manufacturer which authorizes him to speak for his principal on matters relating to the latter’s specialties. The original Power of Attorney is to be notarized in the country of origin by a Notary Public and submitted to NAFDAC
- The applicant shall submit to the office of the Director, Registration and Regulatory Affairs, a written application, stating name of the manufacturer, generic name, brand name (where applicable), strength, indications and obtain prescribed application form which must be properly completed with all required information.
- A separate application form shall be submitted for each drug product. In this context, a drug product means a separate drug formulation.
Documentation Process
- The manufacturer, in the case of imported drug products (from India and China only), must submit evidence that they are licensed to manufacture drugs for sale in the country of origin (Manufacturer’s Certificate). Such evidence must be issued by the competent Health Authority in that country of manufacture.
- There must be evidence that the drug product is manufactured according to Good Manufacturing Practice (GMP).
- 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. I.e. Certificate of Pharmaceutical Product (COPP) that conforms to World Health Organization format.
- The Applicant shall submit 2 dossiers made out in accordance with the Agency’s format.
- Evidence of Trade Mark Approval for brand name from Federal Ministry of Commerce in Nigeria.
- Copy of current Annual License to practice as a Pharmacist for the Superintendent Pharmacist issued by Pharmacists Council of Nigeria.
- Copy of current Certificate of Registration and Retention of Premises issued by Pharmacists Council of Nigeria.
- Comprehensive Certificate of analysis of the batch of product submitted for registration processing.