** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-623322) ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-623322) ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-623322)
** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-623322) ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-623322) ** Customer Service Lines: For Enquiries call 0700-1-NAFDAC (0700-1-623322), For Complaints call 0800-1-NAFDAC (0800-1-623322)

Guidelines

These guidelines are to enable applicants obtain detailed provisions of how to undertake their requested service from NAFDAC. The guidance documents are categorized based on product type and do provide detailed information on: Application, Facility Inspection, Documentation, Labelling, Tariff (Fees) and Timelines.

TitleProduct TypeCategoryStatus
Revised Guidelines for Risk Categorization of Product Dossiers for the Registration of Drug Products for Human UseDrugsGuidance Document (DR&R)Published
Guidelines for Renewal of Certificate of Registration for Drug Products Human and VetDrugsCertificate Renewal (DR&R)Published
NAFDAC Good Storage and Distribution Practices Guidelines for Pharmaceutical ProductsDrugsGuidance Document (PMS)Published
NAFDAC Good Storage and Distribution Practices Guidelines for Pharmaceutical ProductsDrugsGuidance Document (PMS)Published
Guidelines and Requirement for inspection of Food Storage Facilities Warehouse and Issuance of e-Permit for Bulk Raw Materials in NigeriaRegulated ProductsGMP Inspection (FSAN)Published
NAFDAC Good Manufacturing Practice For Pharmaceutical Products Guidelines 2024 - DER-GDL-019-03DrugsGMP InspectionPublished
NAFDAC Inspectors Guide 2023 Regulated ProductsInspectionPublished
NAFDAC Guidelines for Conformity Assessment of IVD Medical DevicesRegulated ProductsGuidance Document (VBM-R&R)Published
NAFDAC Guidelines for Conformity Assessment of Non-IVD Medical DevicesRegulated ProductsGuidance Document (VBM-R&R)Published
Guidelines for Compilation of a Product Dossier for Registration of In Vitro Diagnostics - IMDRF ToCRegulated ProductsRegistration Requirement (VBM-R&R)Published
Guidelines On Variations To Registered Medical Devices Including In Vitro Diagnostics And Related ProductsRegulated ProductsRegistration Requirement (VBM-R&R)Published
Guidelines on the Role of Standards in the Assessment of Medical DevicesMedical DevicesGuidance Document (VBM-R&R)Published
Guidelines For Renewal Of Certificate Of Product Registration For Medical Devices In NigeriaMedical DevicesCertificate Renewal (VBM-R&R)Published
Guidelines For Registration Of Medical Devices In NigeriaMedical DevicesRegistration Requirement (VBM-R&R)Published
Guidelines for Good Refurbishment Practice of Medical Devices (NGRPMD)Medical DevicesGuidance Document (VBM-R&R)Published
Guidelines for Compilation of a Product Dossier for Registration of Non-In Vitro Diagnostic (nIVD ToC)Regulated ProductsRegistration Requirement (VBM-R&R)Published
Guidelines for Conduct of Clinical Trials During EmergenciesDrugsClinical Trial (DER)Published
Guidelines for Clinical Trial Application in NigeriaDrugsClinical Trial (DER)Published
NAFDAC Guidelines for the Recall of Defective Medical ProductsRegulated ProductsGuidance Document (PMS)Published
NAFDAC GMP For Medical Devices, IVDs, Related Products Guidelines 2024Regulated ProductsGuidance Document (DER)Published
Showing 1 to 20 of 160 entries

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