Pharmaceutical products are a major consumable in the Nigerian market. In the past decade, Nigeria has had an overwhelming track record of arrest, prosecution and conviction of illicit and fake pharmaceutical product paddlers. Being an essential part of human life and survival, both local and foreign-made pharmaceutical products are strictly regulated in Nigeria through the instrumentality of the National Agency for Food and Drug Administration and Control (NAFDAC). Generally, it is a legal requirement for pharmaceutical products to be registered with NAFDAC before such products are distributed, sold, imported, exported or used in Nigeria. This article offers a comprehensive discussion on how to register a foreign pharmaceutical product in Nigeria.
What is the regulatory Framework for Foreign Pharmaceutical Products in Nigeria?
Foreign pharmaceutical products entering the Nigerian market are regulated under a structured framework designed to ensure the safety, quality, and efficacy of all medicines supplied to the public. The key pillars of this framework include:
1. The National Agency for Food and Drug Administration and Control (NAFDAC) Act
NAFDAC is the primary regulatory authority responsible for overseeing the importation, manufacture, distribution, and registration of pharmaceutical products in Nigeria. The agency derives its authority from the NAFDAC Act Cap N1 LFN 2004, empowering it to regulate, control, and enforce quality standards for pharmaceuticals.[1]
2. Food, Drugs and Related Products (Registration, Etc.) Act
These regulations provide detailed procedures and requirements for registering pharmaceutical products, whether locally produced or imported.[2]
They cover:
- Documentation requirements
- Labeling standards
- Product evaluation
- Laboratory testing
- Renewal procedures
Which Products Qualify as Pharmaceutical Products?
Any substance or product meant for human or veterinary use, whether in its finished dosage form or as a starting material for such a form, that is regulated under pharmaceutical laws in either the exporting or importing country.[3]
How to register a foreign pharmaceutical product in Nigeria
It is worthy of note that, NAFDAC no longer entertains new applications for the registration of imported regulated products listed on the Nigerian Customs Import Prohibition List and the NAFDAC ceiling list. This is a way to encourage the production of pharmaceutical products that can be produced locally. In other words, only foreign pharmaceutical products not listed can be registered with NAFDAC. The following steps are to be considered when registering a pharmaceutical product for human use:
- The first step is to submit a dossier of the product for screening. This is necessary to obtain a Dossier Screening Clearance, which is a prerequisite for initiating the registration process.
- Once a Dossier Screening Clearance has been issued, the applicant can then proceed to apply for the registration of the pharmaceutical product.
- Interested applicants are required to submit an application letter to the Director General in charge of Drug registration. If there is more than one pharmaceutical product, a separate application form is required for each of the products.
- Submit all necessary documents, including but not limited to:
- A dossier clearance
- Application letter addressed to the Director General, Drug Registration
- Notorized declaration
- Power of attorney, where the applicant owns the brand name or a Contract of manufacturing agreement
- Company incorporation documents from CAC (MEMART, Incorporation certificate, Status Report)
- Manufacturing licence and Certificate of free sale
- Certificate of Pharmaceutical Product
- Trademark Certificate
- License from the Pharmacist Council of Nigeria
- Valid Premise Retention License for the facility
- Letter of invitation for Good Manufacturing Practice
- Upon satisfactory review of the above documents, a Permit of Import Registration Sample will be issued
- The next step after the issuance of a Permit of Import Registration Sample is the submission of a laboratory sample
- A product approval meeting will be held thereafter upon the satisfactory review of the laboratory analysis, Dossier review and GMP of the product facility.
- Where the product is approved, an electronic certificate of product registration and listing will be issued to the applicant.
What is the Timeline for Registration?
The entire process of applying for registration, from acceptance of submission to issuance of NAFDAC registration number, takes 120 days.
Are there any Penalties for Non-Compliance?
Where the application is queried, an applicant is expected to respond to such a query within 90 working days; failure of which will result in a closure of the application.
CONCLUSION
Registering a foreign pharmaceutical product with NAFDAC may seem demanding, but following the right steps makes the process smooth and predictable. By preparing the required documents, complying with regulatory standards, and working closely with a licensed local agent, companies can successfully secure market approval in Nigeria. Ultimately, proper registration not only ensures compliance but also protects public health and strengthens trust in your product. With the right guidance and preparation, your pharmaceutical product can gain timely entry into the Nigerian market.
For enquiries you may contact us on the WhatsApp icon on this page or send an email here, and we’ll respond to you.
[1] Section 5
[2] Section 1 (1)
[3] http://www.nafdac.gov.ng/wp-content/uploads/Files/Resources/Guidelines/R_and_R_Guidelines/GENERAL/Quality-Guidelines-for-Registration-of-Pharmaceutical-Products26381.pdf#:~:text=Pharmaceutical%20product%20(PD)%20Any%20material%20or%20product,the%20exporting%20state%20and/or%20the%20importing%20state.
