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Drug Guidelines

TitleProduct TypeCategoryStatus
Guideline for Renewal of Certificate of Registration for Drug Products (Human and Veterinary Drugs) DR&R-GDL-025-02Regulated ProductRenewal Registration Requirement (DR&R)Published
Guidelines for the Preparation of Summary of Product Characteristics (SmPC) for drug products in NigeriaDrugsSMPC GuidelinesPublished
Patient Information Listing (PIL) Review ChecklistDrugsPIL ChecklistPublished
SMPC Review ChecklistDrugsSMPC ChecklistPublished
Guideline For Lot Release Of Human Vaccines And Other Biologicals 2023Vaccines, Biologics & Medical DevicesLot release (VBM-LSD)Published
Guidance Document on Chemistry, Manufacturing, Control (CMC) And Lot Release For Finished Vaccine Or Biological Medicinal Product Vaccines, Biologics & Medical DevicesLot release (VBM-LSD)Published
Guidelines For Pre-Production Inspection Of Pharmaceutical Manufacturing Facilities In NigeriaDrugsGMP Requirement (DER)Published
Guidelines For Pre- Registration Inspection Of Pharmaceutical Manufacturing Facilities In NigeriaDrugsGMP Requirement (DER)Published
Guidelines For Clinical Trial Process TimelinesDrugsClinical Trial (DER)Published
Guidelines For Submission Of Clinical Trial Progress ReportDrugsClinical Trial (DER)Published
NAFDAC Good Manufacturing Practice (GMP) For Pharm. Products Guidelines 2021DrugsGMP Requirement (DER)Published
NAFDAC Guidelines For Contract Manufacturing Of Finished Pharmaceutical Products In NigeriaDrugsGMP Requirement (DER)Published
Guidance on Regulatory Preparedness for Licensing or Access to COVID-19 VaccinesDrugsLicensing Access to Covid-19 Vaccines(DR&R)Published
Guidelines For Importation Of Active Pharmaceutical Ingredients (APIs)DrugsAPI Requirement (DER)
Guidance Document for Submission of Application in the CTD Format – Vaccines for Human UseDrugsGuidance Document (DR&R)Published
Guidelines for Renewal of Certificate of Registration for Medical Devices Made in NigeriaMedical DevicesRenewal Registration Requirement (DR&R)Published
Guideline for the Renewal of the Certificate of Registration License for Imported Medical DevicesMedical DevicesRenewal Registration Requirement (R&R)Published
Guidelines For Registration of Imported Drugs Vaccines IVDs Under Collaborative Registration ProcedureDrugsRegistration Requirement (DR&R)Published
Guidelines For Labeling Of Investigational Medicinal ProductsDrugsGMP Labeling (DER)Published
Guidelines For Importation And Release Of Investigational Medicinal ProductsDrugsQuality Guidelines (DER)Published
Guidelines For Conduct Of Clinical Trials During EmergenciesDrugsClinical Trial (DER)Published
Guidelines For Clinical Trials Protocol DevelopmentDrugsClinical Trial(DER) Published
NAFDAC Guidelines on Variations to a Registered Pharmaceutical ProductDrugsVariation Guidelines (DR&R)Published
Guidelines For Clinical Investigation Of Medicinal Products In Paediatric PopulationDrugsClinical Trial(DER)Published
Biosimilar Guidance DocumentDrugsQuality Guidance Document (DR&R)Published
Guidelines for Registration of Biosimilars in NigeriaDrugs Local Registration (DR&R)Published
Quality Guidelines for Registration of Pharmaceutical Products26381DrugsQuality Guidelines (R&R)Published
Guidelines for Obtaining Permit to Clear Narcotic drugs, Psychotropic Substances and Drug Precursors_NarcoticClearance Permit (NCS)Published
Guidelines for Obtaining Permit to Import Narcotics, Drugs, Psychotropic Substances and Drug PrecursorNarcoticImport Permit (NCS)Published
Guidelines for Obtaining Permit to Import Schedule 1 Narcotic DrugsNarcotic Import Permit (NCS)Published
Guidelines for Registration of Imported Drug Products in Nigeria (Human and Veterinary Drugs)DrugsImport Registration (DR&R)Published
Guidelines for Registration of Imported Medical Devices in NigeriaMedical DeviceImport Registration (DR&R)Published
Guidelines for Registration of Medical Devices made in NigeriaMedical DeviceLocal Registration (DR&R)Published
Guidelines for Registration of Drug Products Made in Nigeria (Human and Veterinary Drugs)Drugs Local Registration (DR&R)Published
Guidelines for the Inspection of Facilities for Manufacture of Veterinary DrugsVeterinaryGMP Requirement (Inspection)Published
Guidelines for Handling and Disposal of Unwholesome Medicines and Other NAFDAC Regulated ProductsDrugsListing Requirement (I&E)Published
Guidelines for Clearing of Cosmetics and Medical DevicesCosmetic, Medical DevicesImport Clearance Permit (PID)Published
NAFDAC Guideline on Registration Requirements to Establish Interchangeability of Generic Pharmaceutical ProductsDrugsRegistration Requirement (DR&R)Published
NAFDAC Good Manufacturing Practice (GMP) For Pharm. Products Guidelines 2021DrugsGMP Inspection (DER)Published
Guidelines For Clinical Trial Application In NigeriaDrugsClinical Trial (DER)Published
Guideline for Operation of Service Drugs and Orphan Drug SchemeDrugsOperation Guidelines (DR&R)Published
Guidelines for Renewal of Certificate of Registration for Imported Drug Products in Nigeria (Human & Veterinary Drugs)Regulated ProductsRenewal Registration Requirement (DR&R)Published
Guidance on Master Data Attributes for Pharmaceutical Products DGO-GDL-001-00DrugsTraceabilityPublished

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