NAFDAC Guidelines for Renewal of Certificate of Registration for Imported Drug Products in Nigeria (Human and Veterinary Drugs)
Guideline · Health
Guidelines establish procedures for renewing registration of imported human and veterinary drugs in Nigeria, requiring updated certificates and compliance history. They target regulated entities, NAFDAC teams, and industry stakeholders, including label updates. This ensures the continued availability of quality imported medicines.
NAFDAC Guidelines for Renewal of Certificate of Registration for Imported Drug Products in Nigeria (Human and Veterinary Drugs)
What Is This Policy?
Guidelines for renewing the registration of imported human and veterinary drugs in Nigeria.
Who Does It Target?
International pharmaceutical companies exporting human or veterinary medicines to Nigeria; Nigerian importers and marketing authorisation holders for imported drugs; NAFDAC's drug registration and evaluation teams conducting renewal assessments
NAFDAC teams Industry stakeholders
What Does It Aim to Achieve?
Ensure continued availability of quality imported medicines through efficient registration renewal.
Key Features
Renewal Documentation: Updated certificates from country of origin Compliance History: Pharmacovigilance and quality compliance during the registration period Label Updates: Any changes to approved labelling
Current Status
Rollout Stage: Active Coverage: All applicable entities Lead Agency: NAFDAC
How to Access
Regulated entities must comply. Submit renewal application with updated documentation Provide pharmacovigilance summary Obtain renewed registration
Official Resources
Website: nafdac.gov.ng Contact: NAFDAC, Abuja
Legal Framework
Issued under the National Agency for Food and Drug Administration and Control Act 1993 (as amended). Operates alongside the Food and Drugs Act Cap F32 LFN 2004, the Pharmacists Council of Nigeria Act, the ICH Good Manufacturing Practice guidelines, WHO prequalification standards, and the Falsified Medicines guidelines adopted by Nigeria.