IMUN: Everything on this to do list is done except for the NAFDAC final sign off on the lab inspection.
Once the Company obtained drug approval for Lodonal in the Dominican Republic, we were able to begin the new regulatory process in Nigeria for marketing approval.
The Company was required to provide the following documents as part of marketing approval:
Acromax Dossier,
Drug Approval issued by the relevant health/regulatory body Dominican Republic,
Certificate of Pharmaceutical Products (COPP – WHO FORMAT);
Current Good Manufacturing Practice (GMP) Certificate of the manufacturing facility;
Certificate of Registration of Brand Name with the trademark Registry in the Ministry of Commerce in Nigeria,
Clinical Trial Data, Comprehensive Certificate of Analysis; Issued by the manufacturer.
Current Annual License to Practice for the Superintendent Pharmacists issued by the Pharmacists Council of Nigeria;
Current Certificate of Registration Retention of Premise issued by the Pharmacists Council of Nigeria,
100 Samples including packaging,
Patient Data Sheet and
A letter of Invitation to inspect the factory abroad.
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