Drug Registration Process In Nigeria
Drug registration is a system that subjects all pharmaceutical products to pre-marketing evaluation, marketing authorization, and post-marketing review to ensure that they conform to required standards of quality, safety, and efficacy established by national authorities. The outcome of the drug registration process is the issuance or the denial of a pharmaceutical product marketing authorization or licence.
The drug registration process in Nigeria entails submission of a registration pack to both NAFDAC and the Federal Ministry of Trade & Investment. NAFDAC reviews the submission and performs an assessment of the application for new marketing authorisations with respect to the quality, safety and efficacy. The associated tariff for each registration is specific to the type of product under consideration i.e. New Chemical Entities, Orphan Drugs, Over The Counter (OTC) or other Medicines on the WHO essentials list. The tariff covers costs for (a) import permit, (b) Processing fee, (c) Laboratory Analysis, (d) Certification and ( e) GMP Inspection.
The Federal Ministry of Trade & Investment on the other hand is concerned with matters of brand name and or trade mark. It is generally, expected and even mandated that any trade name submitted should be domesticated in compliance with the sovereignty of the nation. However, where there is a need to maintain the international brand name, a fee usually applies. The trademark registration would normally precede the NAFDAC registration.
At BethAri, we can facilitate the process of trademark and drug product registration and project manage the entire process including facilitating the correspondence loop between NAFDAC and applicant. Where required, we can also perform a gap analysis of the registration pack and a subsequent dossier compilation (resulting from the gap analysis) where applicable.