Pre-Shipment Provisional Registration Of Imported Drugs And Other NAFDAC Regulated Products #07192
August 14, 2019,
The National Agency for Food and Drug Administration and Control (NAFDAC) hereby informs the public, especially manufacturers and manufacturers’ representatives that drugs and other regulated products approved by the Agency for registration and renewal will henceforth be granted provisional registration pending confirmation of quality of two batches/lots of the products.
This measure has become necessary to ensure that products manufactured, imported, distributed and sold after registration or renewal of registration conforms to quality specifications. In addition, it will prevent situations where quality of products manufactured, imported, distributed and sold are different from what is registered by the Agency.
On confirmation that two batches/lots of product granted provisional registration or renewal conforms to quality specifications, the product is granted full registration status with effect from the date of approval for registration.
In a situation where the batches/lots of the product granted provisional registration or renewal did not conform with quality specifications, such batches/lots will be forfeited to the Agency and destroyed. The manufacturer or importer of the affected product(s) will be responsible for the cost of destruction.