Drug Registration Process In Nigeria

Ministry of Health 

Federal Ministry of Health and Social Welfare

MOH Website 

https://www.health.gov.ng/

Regulatory Authority 

National Agency for Food & Drug Administration & Control. (NAFDAC)

Regulatory Website 

https://www.nafdac.gov.ng/

Local Authorized Representative Required 

Yes 

Drug Approval Process in Nigeria

Step 1: Approval and Registration of Trademarks

In Nigeria, registering a trademark is a prerequisite to registering a medicinal product. Nigerian trademark registration is handled by the Commercial Law Department Trademarks, Patents, and Designs Registry of the Ministry of Industry, Trade, and Investment. Prepare and submit the trademark application to the Commercial Law Department Trademarks, Patents, and Designs Registry of the Ministry of Industry, Trade, and Investment. The application should include details about the trademark and its intended use.

Step 2: Filtering and Submission of Dossiers

For screening, the application and all supporting papers must be sent to the NAFDAC. Compile all the facts and paperwork needed for the medical product’s regulatory approval. This usually contains information on the ingredients, production method, quality assurance, safety, effectiveness, and labeling of the product.

Step 3: Label vetting and import permit

After all the paperwork has been successfully screened and reviewed, import permission is granted. The products are then sent for inspection after this. Gather all the information and documentation required for the regulatory approval of the medical product. This often includes details about the product’s ingredients, manufacturing process, quality control, safety, efficacy, and labeling.

Step 4: Send Samples for Analysis in the Lab

Once the product labels have been successfully vetted, laboratory samples are submitted. Make sure the samples are representative of the finished product before sending them to the lab. To ensure that the samples you collect accurately represent the makeup and caliber of the medicinal product, follow the recommended sampling procedures.

Step 5: Meeting for Product Approval

After the lab analysis, GMP of the production facility, and a satisfactory assessment of the dossier, the products are brought forward for “Approval Meetings.” Verify that the production facility’s Good Manufacturing Practice (GMP) review was successfully completed and that the laboratory analysis of the product samples was finished. 

These actions are crucial for confirming the medication’s efficacy, safety, and quality. Following the completion of the preliminary evaluations, the applicant might need to be ready for an approval meeting. This entails gathering all pertinent paperwork, such as GMP compliance certificates, laboratory reports, and any other supporting data.

Step 6: Notification is Issued

A compliance directive will be provided for Nigerian drug registration and approval goods, and notification of registration or listing will be sent to the applicant for products approved at the Annual Meeting. Following the approval meeting, a compliance directive could be given by the regulatory body—like the National Agency for Food and Drug Administration and Control (NAFDAC)—once they have evaluated and authorized the product. This directive describes any post-approval or compliance requirements the applicant must follow.

Documents

A formal written application including the manufacturer’s name, brand name, and product details submitted to the Director of Registration and Regulatory Affairs for product registration.

• Complete NAFDAC Application Form D-REG/001 as directed.
• Proof of having paid the required fees.
• The company’s certificate of incorporation
• The NAFDAC-issued certificate of inspection or recognition
• Original Power of Attorney document from the maker (if applicable, if imported)
• Nigerian trademark registration for a brand name
• A Pharmaceutical Product certificate that has been signed and approved (applied to medications only).
• A letter from the firm inviting you to visit the factory overseas, together with the complete names and location of any plants (if any).
• Product sample pack for quality assessment and examination.
• The product producer must provide a duly executed power of attorney, which must be notarized by a Notary Public in Nigeria and typewritten.
• A certificate of free sale stating the name of the maker and the products that need to be registered was obtained and granted by the appropriate health and regulatory agency in the nation of the manufacturer. Additionally, the Nigerian Embassy in the country of origin must authenticate it. Any other Embassy or High Commission of any Commonwealth or West African nation can validate the document in nations where there isn’t an Embassy or High Commission of Nigeria.

Registration fee

$10,500