Active Pharmaceutical Ingredients (APIs) Import Permit Incentives For Low And Medium Risk Finished Pharmaceutical Products (FPP) Manufacturers #04191
Ensuring quality of FPPs is largely premised on enforcing standards across the API value chain hence the stringent control on issuance of permit for APIs. The Agency is however aware of challenges faced by FPP manufacturers in submitting Drug Master File (DMF) for APIs intended for importation.
Considering the need to meet our local drug consumption in the short term, the top management team of NAFDAC hereby grants moratorium to local Pharmaceutical manufacturers categorized as low and medium risk for 12 and 6 months respectively, on DMF requirement for APIs import permit. The moratorium takes effect from 1st of May 2019. All other relevant documents shall be submitted as required.
We believe that this incentive will not only increase access to quality, safe and efficacious medicines but will promote healthy aspirations for low risk manufacturers to sustain their GMP status and the medium risk manufacturers to aim to low risk status. Likewise, the high-risk manufacturers will also upscale.
This moratorium excludes high-risk manufacturers, API brokers and vendors who shall follow the normal regulatory pathway in obtaining e-import permit as stipulated in our guidelines for importation of APIs.
Please note: The API manufacturers or local representatives can submit the DMF directly to our email at firstname.lastname@example.org or couriered to:
Drug Evaluation and Research Directorate,
National Agency For Food and Drug Administration and Control
(NAFDAC), Apapa-Oshodi Express Way,