Public Notice: Manufacturers of Pharmaceuticals and Biologicals Drug

Public, in general, and Pharma Industry, in particular, is informed through this Public Notice that Drug Regulatory of Pakistan (DRAP) has deployed an improved version  of online application management system namely Pakistan Integrated Regulatory Information management System (PIRIMS) for filling and processing of applications.

Applications for site verification, Lay out Plan approval, Grant of Drug Manufacturing Licence, Renewal of Drug Manufacturing Licence, approval of technical staff etc would be filed and processed on PIRIMS. Thereby, applicants would be able to file their applications from their offices/ homes and receive the regulatory communication / letters / shortcomings / reply through this online system.

Manufacturers of pharmaceuticals and Biological drugs are invited to file their applications for site verification, Lay out Plan approval, Grant of Drug Manufacturing Licence, Renewal of Drug Manufacturing Licence and post licence variance through PIRIMS. No application in hard form would be accepted after 15th November, 2021.

You are advised to register as well as upload data and submit your application using following address

http://pirims.dra.gov.pk

Submission of Deficient Information / Documents (Enlistment Evaluation Committee (EEC) 92nd meeting held on 30th July, 2021)

The applications of following applicants were placed before the Enlistment Evaluation Committee (EEC) in its 92nd meeting held on 30th July, 2021 and the same have been deferred being deficient of the information / documents as specified in column (3) of the Table below which may be furnished within 20 days of uploading of this letter on official website of DRAP along with soft data as per Annexed Format at the end of this letter/document.