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Drug Registration Process In Nigeria

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

 

Generic Drug Approval

Documents Required

  • Duly completed Drug Registration Form
  • Application letter for Registration of product(s)
  • Power of Attorney/Contract Manufacturing Agreement  Manufacturing Licence
  • Certificate of Pharmaceutical Products (CoPP) – WHO Format
  • Current Good Manufacturing Practice (GMP) Certificate of the manufacturing facility
  • Certificate of Registration of Brand Name
  • Certificate of Business Incorporation of the importing company with the corporate affairs commission in Nigeria
  • Comprehensive Certificate of Analysis.
  • Current Superintendent Pharmacists License to practice
  • Valid Pharmaceutical Premises License
  • Dossier in CTD – WHO Format
  • Notarized Declaration
  • GMP Invitation letter
  • Copy of Expiring Certificate/License – Renewal Application 

Registration Process

Submitting the NAFDAC registration application form

GMP assessment and manufacturing facility inspection

Product sample submission

Testing in the Lab after a Satisfactorily

Marketing Authorization is granted and NAFDAC Number Subsequently

Product is Presented for Approval

  • Submitting the NAFDAC registration application form- Obtain the official NAFDAC registration application form. This form can typically be obtained from the NAFDAC office or their official website. Ensure that you are using the most current version of the form.
  • GMP assessment and manufacturing facility inspection- After submitting the NAFDAC registration application form and before or during the review process, the applicant typically provides documentation related to GMP. This includes details about the manufacturing processes, quality control measures, and adherence to GMP guidelines.
  • Product sample submission -Typically, the regulatory authority, such as the National Agency for Food and Drug Administration and Control (NAFDAC), will provide specific guidelines on how to submit product samples. This may include details about the quantity of samples required, packaging specifications, and any specific labeling requirements. Submit the samples to laboratories that are approved by the regulatory authority. These laboratories can conduct the necessary tests to verify the safety, quality, and efficacy of the medicinal product.
  • Testing in the Lab after a Satisfactorily- After a satisfactory assessment, the regulatory authority may request or allow the submission of product samples for laboratory testing. This step is often part of the broader evaluation process to verify the safety, quality, and efficacy of the medicinal product.
  • Marketing Authorization is granted and NAFDAC Number Subsequently- The regulatory body gives the authorized pharmaceutical product a distinct NAFDAC number after it has been granted marketing authorization. This number is used as identification and is usually found on the packaging for the product.
  • Product is Presented for Approval- It could be necessary for the applicant to appear before a board or regulatory committee and defend the product. The applicant can answer any queries, offer further information, and argue in favor of the product during this presentation.