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Asia: Pakistan gives manufacturers 30 days to update finished product specifications in online portal

2023/03/23  DRAP

DRAP has deployed an online application management system namely, Pakistan Integrated Regulatory Information Management System (PIRIMS) for processing of regulatory information related to licensing, registration and inspections of pharmaceutical and biological drugs.

All the Registration Holders of pharmaceutical and biological drug products are directed to update the finished product specifications and validated testing procedures i.e. Pharmacopoeial or in case of non-availability in any pharmacopeia, Innovator / Manufacturer’s Specification, in the corresponding product profile / details in the PIRIMS at http://pirims.dra.gov.pk. The portal to perform the above-said activity will remain accessible for thirty days after publication of this notice and afterwards, no request shall be entertained. It is further clarified that after the lapse of the due time for above-said activity, necessary regulatory fee may apply.

To continue reading this article please go to DRAP Notice .