Guidance Document for Submission of Application in the Common Technical Document format - Vaccines for Human Use
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
This guideline is technically and structurally inspired by Health Canada’s guidance document on harmonized requirements for the licensing of vaccines and guidelines for the preparation of an application and the World Health Organization (WHO) working document on vaccine prequalification dossier. This guideline document has been developed in pursuance of the National Agency for Food and Drug Administration and Control (NAFDAC) Act Cap. N1, LFN 2014 and made to provide guidance to applicants on the organization of information to be provided to the agency in seeking marketing authorization for Vaccines for human use. The document applies to all vaccines to be authorized for human use, regardless of where they are manufactured.
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 for health ⬤
Guidance Document for Submission of Application in the Common Technical Document format - Vaccines for Human Use Current Version
January 2022
This guideline is technically and structurally inspired by Health Canada’s guidance document on harmonized requirements for the licensing of vaccines and guidelines for the preparation of an application and the World Health Organization (WHO) working document on vaccine prequalification dossier. This guideline document has been developed in pursuance of the National Agency for Food and Drug Administration and Control (NAFDAC) Act Cap. N1, LFN 2014 and made to provide guidance to applicants on the organization of information to be provided to the agency in seeking marketing authorization for Vaccines for human use. The document applies to all vaccines to be authorized for human use, regardless of where they are manufactured.
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