NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines on Variations to a Registered Pharmaceutical Product
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
This guidance document is technically and structurally inspired by the World Health Organisation’s variation guideline on the details of the various categories of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products. The objectives of these guidelines are to assist applicants with the classification of changes made to the quality part of a registered Finished Pharmaceutical Product (FPP) and provide guidance on the technical and other general data requirements to support changes to the quality attributes of the Active Pharmaceutical Ingredient (API) or FPP.
Process Flow
Department of Registration and Regulatory Affairs ⬤
Office of the Director General NAFDAC ⬤
Office of the Permanent Secretary, Ministry of Health ⬤
Office of the Minister of State for Health ⬤
Office of the Minister of Health ⬤
Federal Executive Council ⬤
NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guidelines on Variations to a Registered Pharmaceutical Product Current Version
January 2022
This guidance document is technically and structurally inspired by the World Health Organisation’s variation guideline on the details of the various categories of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products. The objectives of these guidelines are to assist applicants with the classification of changes made to the quality part of a registered Finished Pharmaceutical Product (FPP) and provide guidance on the technical and other general data requirements to support changes to the quality attributes of the Active Pharmaceutical Ingredient (API) or FPP.
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