Procedure for importing drugs into Nigeria - pharmaceutical products registration

News date: 23 February 2021Source: https://www.lexology.com/library/detail.aspx?g=60e8ee23-f839-4bc6-948d-deea567f6a8e

Importing pharmaceutical products and drugs into Nigeria must follow the statutory process and guidelines.  First, it is necessary to emphasize that no drug shall be manufactured, imported, exported, advertised, distributed or used in Nigeria unless it has been registered following the provisions of the NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL (NAFDAC) Act CAP N1 (LFN) 2004, other related legislations and the accompanying regulations.

The NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL (NAFDAC) is the government agency responsible for the registration, controlling and regulation of the importation, exportation, manufacture, advertisement, distribution, sale and use of processed foods, beverages, medicines for human or animal use, cosmetics, medical devices, detergents, packaged/bottled water and chemicals  (together "regulated products").

The GUIDELINES FOR REGISTRATION OF IMPORTED DRUG PRODUCTS IN NIGERIA (HUMAN AND VETERINARY DRUGS) 2018 sets out the procedures for registrations of foreign drug products.

PROCEDURES FOR IMPORTATION OF DRUGS

  1. First, a written application for registration of imported drug should be made on the company’s letterhead paper to the Director-General (NAFDAC), ATTENTION.
  2. The application letter should include the generic name of the product and brand name (where applicable).
  3. A NAFDAC application form for Product Registration should be completed.
  4. A separate application form should be submitted for each product.

DOCUMENTATION TO OBTAIN PERMIT/LICENSE TO IMPORT DRUGS

The following documents (all originals) and two (2) sets of photocopies must be submitted:

  1. The completed online Registration form to be submitted at the Liaison Office of the Director (LOD), R & R Directorate, Ground Floor, NAFDAC Office Complex, Oshodi-Apapa Express Way, Isolo, Lagos State or any NAFDAC Office (outside Lagos):
  2. Notarized Declaration to be completed (typed), signed by Declarant and notarized by a Notary Public in Nigeria.
  3. Power of Attorney or Contract Manufacturing Agreement. An applicant on behalf of a manufacturer outside Nigeria must file evidence of Power of Attorney from the manufacturer, which authorizes him to speak for his Principal on all matters relating to the latter’s specialities. The Power of Attorney shall:
  • be issued by the manufacturer of the product.
  • be signed by the Managing Director, General Manager, Chairman or President of the Company, stating the names of the products to be registered. The Power of Attorney shall also state authority to register the product with NAFDAC’.
  • state ownership of Brand name(s)/Trademark.
  • be notarized by a Notary Public in the Country of manufacture.
  • be valid for at least five (5) years.
  1. Certificate and other documents of business incorporation of the importing company in Nigeria with Corporate Affairs Commission.
  2. Manufacturing License/Certificate of Free Sale.
  3. Evidence that they are licensed to manufacture drugs for sale in the country of origin (Manufacturer’s Certificate). The license shall be issued by a relevant Health/Regulatory body in the country of manufacture.
  4. Evidence of registration of all the products’ brand names with Nigerian Trademark Registry.
  5. Copy of valid Annual License to practice for the Superintendent Pharmacist issued by Pharmacists Council of Nigeria.
  6. Evidence of valid Premises Retention License for the facility.
  7. Comprehensive Certificate of Analysis for the product(s).
  8. Label or artwork of the product
  9. Letter of Invitation for Good Manufacturing Practice (GMP) Inspection.

Upon successful screening of documentation and review of supporting documents, an Import Permit will be issued and afterwards, the products will be submitted for vetting. After successfully vetting the product labels, laboratory samples are submitted. The following documents would accompany it;

  1. Evidence of payment to the Agency fees.
  2. Certificate of Analysis.
  3. Evidence of submission for vetting.

Upon satisfactory review, satisfactory GMP of the production facility and satisfactory laboratory analysis of the product, products are presented for Approval Meetings.

For products labels with compliance issues, compliant artworks may be submitted with a commitment letter from the manufacturer stating that the commercial products will comply.

For products approved at the meeting, Notification of Registration or Listing is issued to the applicant while compliance directive is issued to those not approved.

Drug product shall be registered or considered for registration if there are scientifically documented evidence to prove that such a product has a clinical advantage over the single drug available for the same indication(s).

NAFDAC reserves the right to revoke, suspend or vary a certificate during its validity period. Furthermore, filing an application form or paying an application fee does not confer registration status. Failure to respond promptly to queries or enquiries raised by NAFDAC on the application (within 90 working days) will automatically lead to the closure of the Application.

The timeline for product registration from acceptance of submissions to issuance of the Registration number is average of 120 working days.

In conclusion, registration of any food and drug with NAFDAC is mandatory before such company can commence operations and sales in Nigeria. It is also noteworthy to state that a company producing different products must register each of them separately.

Also, due to the unprecedented emergence of  Covid-19 pandemic, products necessary and critical in response to the pandemic are given emergency approvals and applications for registration of products deemed to have urgent public health impact will be processed and given conditional and limited approvals.