Unprofessional Act Of Unapproved Pictorial Representation And Change In Product Formulations

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We have observed with dismay the growing unethical and unprofessional practices of several manufacturers/exporters of pharmaceutical products with regards to product package design and drug formulation for Prescription Only Medicines. This has become rampant as several prescription medicines are manufactured and distributed with outrageous unapproved pictorial representation and change in product formulations. The consequences of this unethical practice include, drug abuse, public health risk and national security challenges.

NAFDAC has in response come up with the following decisions:

1. All Manufacturers and exporters are to ensure strict compliance to NAFDAC registration guidelines, labelling and Good Manufacturing Practice Regulations as the products were registered. The guidelines and regulations are available on NAFDAC website https://nafdac.gov.ng
2. All Prescription only Medicines (PoM) and other categories of pharmaceutical products must strictly follow NAFDAC approved formulations and package designs. All products for which orders have been made to the manufacturers on or before 1^st May, 2022 or which may already be on the production line will be expected to be cleared from the ports between 1^st May, 2022 and 31^st October, 2022. During this period of moratorium all statutory and administrative charges will be applied accordingly.
3. Note that clearance of products from China and India is contingent upon processing and issuance of Clean Report of Inspection and Analysis (CRIA) issued by NAFDAC Approved CRIA Agents. Any regulated product from these countries without CRIA will be “On Hold” and sampled for laboratory analysis in Nigeria. Full release is only consequent on a satisfactory laboratory analysis regardless of how long it takes to conclude the laboratory analysis and other regulatory activities.
4. Any violative product that is boarded on airlines or shipping vessels from 1^st November, 2022 will be confiscated upon arrival in Nigeria and any erring importer and manufacturer/exporter will be subjected to strict penalties, sanctions, product deregistration and consequent blacklisting.
5. Moratorium for the distribution of violating products within the distribution chain commences from the onset of the moratorium for product clearance from the ports as stated in ‘2’ above and will extend for an additional period of six (6) months to 30^th April, 2023.
6. Any violating products found in circulation from 1^st May 2023 would be mopped-up and seized by NAFDAC.
7. All manufacturers/exporters who are in doubt of the approved formulation and package design presented to them by Nigeria Importers can contact NAFDAC via drugregistration@nafdac.gov.ng

NAFDAC………safeguarding the health of the Nation!!!

Director General