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.
Regulatory Updates
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.
Submission of Deficient Information / Documents (Enlistment Evaluation Committee (EEC) 91st meeting held on 13th July, 2021)
The applications of following applicants were placed before the Enlistment Evaluation Committee (EEC) in its 91st meeting held on 13th 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.
S.R.O 1347(I)/2021 (Notification Regarding Amendments in Rule 20A and Schedule-H of the Drugs (Licensing, Registering and Advertising) Rules,1976 Pertaining to Contract Manufacturing.
Date Wise FIFO List of Applications For Provisional Enlistment Of Products Applied By Herbal/Unani Firms (FIFO List 2020)
Date Wise FIFO List of Applications For Provisional Enlistment Of Products Applied By Nutraceutical Firms And Firms Having Herbal/Unani Sections Along With Nutraceutical Sections (FIFO List 2020)
“In continuation to the previous FIFO list uploaded on official website of Drug Regulatory Authority of Pakistan on 29th June, 2021 and after incorporating the responses submitted by the firms within the stipulated time, following is the list of applications received for provisional enlistment of products with the Division of Health & OTC Products, Drug Regulatory Authority of Pakistan, Islamabad under provisions of SRO 412 (I)/2014 dated 27-5-2014. The processing of these applications under provisions of above said SRO will be dealt on First Come First Serve basis as per sequence of R&I date mentioned against each application.
Please note that formulations of all products of respective companies must be forwarded in MS Word & MS Excel Formats (Soft Copy) annexed at the end of this document (Annexure-I) to the official e-mail “hotcdivision∂gmail.com” of Health & OTC Division with the title “M/s…………. FIFO List 2020” within 15 days positively. Soft Formulations should be provided as per data given in Form-3 already submitted with dossier in hard form. Any discrepancy found in the submitted data in soft and hard shall be liable to rejection of the product application.
Date Wise FIFO List Of Applications For Provisional Enlistment Of Products Applied By Homeopathic Firms (FIFO List 2020)
“In continuation to the previous FIFO list uploaded on official website of Drug Regulatory Authority of Pakistan on 29th June, 2021 and after incorporating the responses submitted by the firms within the stipulated time, following is the list of applications received for provisional enlistment of products with the Division of Health & OTC Products, Drug Regulatory Authority of Pakistan, Islamabad under provisions of SRO 412 (I)/2014 dated 27-5-2014. The processing of these applications under provisions of above said SRO will be dealt on First Come First Serve basis as per sequence of R&I date mentioned against each application.
Please note that formulations of all products of respective companies must be forwarded in MS Word & MS Excel Formats (Soft Copy) annexed at the end of this document (Annexure-I) to the official e-mail “hotcdivision∂gmail.com” of Health & OTC Division with the title “M/s…………. FIFO List 2020” within 15 days positively. Soft Formulations should be provided as per data given in Form-3 already submitted with dossier in hard form. Any discrepancy found in the submitted data in soft and hard shall be liable to rejection of the product application.