The National Agency for Food and Drug Administration and Control (NAFDAC) regulates the importation, manufacturing, and distribution, while the Pharmacists Council of Nigeria (PCN) licenses premises and controls professional practice.
Frequently asked questions
How long does it take to register a product with NAFDAC?
Registration of a pharmaceutical product takes approximately 120 working days from the acceptance of the application.
What are the requirements for importing drugs into Nigeria?
Foreign manufacturers must appoint a local representative (a registered Nigerian company) to submit documentation for registration and obtain a Certificate of Registration, which is valid for 5 years.
How are fake or counterfeit drugs addressed?
NAFDAC conducts inspections, sanitizes open drug markets, and uses post-marketing surveillance to seize counterfeit products.
What is the role of PCN in distribution?
The PCN ensures that registered pharmacies and distribution outlets comply with good distribution practices and that only licensed pharmacists handle pharmaceutical products.
Can I start an online pharmacy?
Yes, to operate within the legal framework, requiring licensing from the PCN and adherence to NAFDAC guidelines.
How is drug advertising regulated?
Prescription medicine ads to the public are prohibited by the World Health Organization (WHO), and all marketing materials must be approved by NAFDAC.
What is the current trend in the industry?
The industry is shifting from manual processes toward digital, technology-driven, and traceable distribution networks to improve efficiency and reduce counterfeiting Business Cardinal.
