User Guide For Online Import / Export Applications Software.
News & Updates
Pre-Submission Screening Checklist for Biological Registration Dossier
Holding Of E-Kachehri
As per directions of Prime Minister’s office for reaching out to public through Khuli E-Kacheri, CEO-DRAP has been pleased to schedule holding of 13th Khuli E-Kachehri through LIVE session on official Facebook page of DRAP (www.facebook.com/officialDRAP) on 22nd October-2021 (Friday) at 10:00 am to address public complaints relating to DRAP.
Certificate Of Good Manufacturing Practices (GMP) For Establishment Units Manufacturing Medical Devices: Policy Board Decision.
Training: Implementation of online software for import export clearance
Deficiency letter of all deferred products in 93rd meeting of EEC held on 11-08-2021
Import of Short Shelf Life Material(s)/Product(s).
I am directed to refer to the subject cited above and to state that the “Recommendatory Committee to Recommend Import of Short Shelf-life Drugs” in its 50th Meeting held on 18th October, 2021 decided to issue the following Advisory: –
- The Manufacturers/Importers be advised to apply for pre-import permission for their import consignments with Short Shelf Life. Post import cases will be considered in very exceptional circumstances of Force Majeure.
- The Committee further advised to charge ‘Miscellaneous Fee’ (for each Batch of Short Shelf Life Material / Product being imported) for all cases recommended after May 2021.
2. The above recommendations of the committee have been approved by the Competent Authority i.e. CEO, DRAP and the same are being communicated for compliance in true letter and spirit. please.
Holding Of Khuli E.Kachehri
As per directions of Prime Minister’s office for reaching out to public through Khuli E-Kacheri, CEO-DRAP has been pleased to schedule holding of 14th Khuli E-Kachehri through LIVE session on official Facebook page of DRAP (www.facebook.com/OfficialDRAP) on 24th November-202l (Wednesday) at 10:00 am to address public complaints relating to DRAP.
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
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.