Minutes Of 313th Meeting of Registration Board
Drug Product Recall: M/S. Zakfas Pharmaceuticals (Pvt.) Ltd., Multan issued voluntary recall Of Biosal Injection (B.No. BSG038 To BSG055)
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
Drug Product Recall: Lefin Pediatric Suspension (Batch # 332v) by M/s. Leama Chemi Pharma (Pvt) Ltd. Peshawar.
Ethical Marketing to Healthcare Professionals Rules, 2021 (S.R.O. 1472(I)/2021)
Drug Product Recall: Rem-D Iv Infusion (Batch # Rd109) by M/s. Liven Pharmaceuticals (Pvt.) Ltd., Kasur
The Ethical Marketing to Healthcare Professionals Rules
The Drug Pricing Policy, 2018
Drug Pricing Policy 2018 (as amended)
Drug Pricing Policy, 2018 (as of June 12, 2018)
S.R.O No. 9-13/2016-DDC(P) (issued on January 21, 2019)
S.R.O No. 11-2/2020-DD(P) (issued on July 15, 2020)
S.R.O No. 678(I)/2023 (issued on June 09, 2023)
The Medical Device Rules, 2017
The Medical Device, Rules 2017 (as amended)
The Medical Device Rules, 2017 (as on January 16, 2018)
S.R.O 526(I)/2021 (issued on 30-04- 2021)
S.R.O 1500(I)/2021 (issued on 22-11-2021)
S.R.O 430(I)/2022 (issued on 18-03-2022)
S.R.O 559(I)/2022 (issued on 27-04-2022)
NOTIFICAITON No.F.8-9/2021-A-III (Coord).
In compliance of Prime Minister’s Office Islamabad U.O.No. I (45)/DS(PMDU-ly2l2l dated l4-10-2021. the Drug Regulatory
Authority of Pakistan (DRAP) is pleased to notify Mr. Aamar Latif. Deputy Director (Legal Affairs), DRAP, Islamabad to act as Facilitation Officer for dedicated facilitation desk of overseas Pakistanis.