Application shall be received for detailed evaluation if all the below mentioned documents are submitted.
Regulatory Updates
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.
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.
Draft Guidelines for Establishment of Pharmaceutical Unit and Post License Changes (for Views/Comments)
Draft Guidelines for Imports & Exports of Therapeutic Goods (for Views/Comments of stakeholders)
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.