The National Agency for Food and Drug Administration and Control (NAFDAC) is a Nigerian federal agency under the Federal Ministry of Health that is responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, chemicals and packaged water.
NAFDAC Permits cover two categories:
If a manufactured or imported goods fall within any of these two categories registration with the NAFDAC is important. Where the product is a foreign product, a power of attorney duly executed for a Nigerian representative of such product registered from the manufacturer and signed by the Company’s Managing Director, Chairman or President, giving authorization to the Nigerian agent to act in such capacity is required.
The registration process for NAFDAC Permit is in two general stages:
- Application for approval to bring in samples – applicable to goods manufactured outside Nigeria
- Application for full registration of product – applies whether the goods are locally manufactured or imported into the country
Application for Approval to Bring in Samples:
For the purpose of registration, a foreign company needs to provide samples of its product for testing/inspection. However, this is impossible without proper approval to bring such samples into the shores of the country. In this category, NAFDAC grants special written authorization or import permit to enable importers to bring the samples of their products. Also documents required for clearing and taking delivery of samples must be obtained from the Manufacturer and other appropriate bodies in the country of origin.
Application for Full Registration of Samples:
In this category, the producer is required to present an application form for each product as NAFDAC approval is granted for each specific product. This form is to be submitted to the registration division of NAFDAC agency.
The key requirements for the registration process are as follows:
The general requirements for the registration on either of the above-mentioned stages of the permit include the following:
- A written application for product registration shall be made to the Director (Registration and Regulatory Affairs) stating the name of the manufacturer, the generic name (and brand name, if applicable) of product, product strength and indications.
- The applicant should obtain and fill the prescribed NAFDAC application form (Form D-REG/001)
- Certificate of Incorporation issued by the Corporate Affairs Commission
- Comprehensive Certificate of analysis of the batch of the product for registration from the manufacturer stating name and signature of the analyst.
- Packs of the products samples
- Evidence of pre-product inspection or Certificate of Recognition issued by NAFDAC
- Notarized original copy of the duly executed Power of Attorney from the product manufacturer (imported product)
- Certificate of Manufacture issued by the competent health or regulatory authority in the country of origin and authenticated by the Nigerian Mission in that country (if foreign import). Where there is no Nigerian mission, the British High Commission or an ECOWAS country Mission will authenticate.
- If contract-manufactured, Contract Manufacturing Agreement properly executed and notarized by a Notary Public in the country of manufacture.
- Evidence of Membership of the State’s Traditional Medicines Board (Herbal Medicines)
- Technical Document (Herbal Medicines)
- Certificate of Pharmaceutical Products (COPP) duly issued and authenticated
- Current Superintendent Pharmacists license to practice issued by the Pharmaceutical Council of Nigeria
- Premises Registration License from Pharmacists Council of Nigeria (PCN)
- Warehouse acquisition or premises acquisition(where applicable)
- Certificate of Trademark Registration of brand name with trademark registry in the Ministry of Commerce here in Nigeria
- Letter of invitation from manufacturer to the Director General of the NAFDAC to inspect factory abroad, stating full name and location of the plant.
- Informative, clear and accurate labeling of the products
- Payment of the prescribed fees.
However, it is worthy of note that the 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.
Upon completion of the registration process, NAFDAC would assign a unique number to all the registered products. The registration is usually valid for a period of 5 years and it must be renewed before the licensee can maintain the usage. Although how to renew NAFDAC permit also involves some documentation and payment of prescribed fee, but this is not as significant as filing a new application
NAFDAC process can be concluded within 1-3 months depending on how swift the company seeking registration is able to compile the required necessary items for submission.
The failure to obtain a NAFDAC approval or registration before distributing any drugs or processed food or food materials may lead to a complete seizure of such products by the government.