Government of Pakistan
Ministry of National Health Services, Regulations & Coordination
Drug Regulatory Authority of Pakistan
Manufacturers of Pharmaceuticals and
Attention:-
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 pre and post
licence variance through PIRIMS. No application in hard form would be accepted after
21st February, 2022.
You are advised to register as well as upload data and submit your application using
following address
http://pirims.dra.gov.pk
Division of Drug Licensing
Drug Regulatory Authority of Pakistan
