Guidelines and Forms

NIGERIA

Nigeria Guidelines on RRFA website

NAFDAC good manufacturing practice guidelines for pharmaceutical products 2016 V 13 new

NAFDAC Good Distribution Practices Guidelines for Pharmaceutical Products 2016 V13

NAFDAC Good Clinical Practice Guidelines 2016 V13

NAFDAC Good Pharmacovigilance Practice Guidelines 2016 V13

NAFDAC Good Practices for Pharm Quality Control Lab 160101 v13

Guidance Document on the COMMON TECHNICAL DOCUMENTS for Industry

Guidelines for Locally Manufactured Medicines d150814.

Guidelines for Pack Size Extension for Drug Product (no date)

Guidelines for Packaging Bulk Semi-finished Medicines d150814

Guidelines for Processing Demand Reduction Programs d150814.

Guidelines for Registration of Imported Medical Devices d150814

Guidelines for Registration of Imported Medicines d150814

Guidelines for Registration or Listing of Herbal Medicines d150814.

Guidelines for Registration or Listing of Herbal Medicines d150814.

Guidelines for Renewal of Imported Regulated Products received 120928

Guidelines for Addditional or Change of Source of Imported Medicines d150814.

Guidelines for Advertisement of Regulated Products received 120928

Guidelines for Change of Brand Name of Registered Products received 120928

Guidelines for Change of Manufacturer’s Representative for Registered Imported Product received 120918

Guidelines for Change of Plant Address for Manufacturer received 120928

Guidelines for Clearance of imported Medicines d150814

Guidelines for Clinical Trials d150814

Guidelines for GCP d150814

Guidelines for GMP d150814

APCON Advertising Guidelines 070903

Drug Registration Application Form (no date)

Biosimilars Guidance Document 1212XX

Guidelines for Change of Product Package Label Design of All Regulated Products received 120928

Guide for Reporting Adverse Reactions to Marketed Drugs in Nigeria d12XXXX

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