2021 – Drug Regulatory Authority of Pakistan

Guidelines On Good Pharmacovigilance Practices For Registration Holders

User Guide For Online Import / Export Applications Software.

CDL has declared Dextrose Infusion 25% (Batch # A042C21) as substandard, Manufactured By M/S. Otsuka Pakistan Ltd., Hub.

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Application shall be received for detailed evaluation if all the below mentioned documents are submitted.

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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 13^th Khuli E-Kachehri through LIVE session on official Facebook page of DRAP (www.facebook.com/officialDRAP) on 22^nd October-2021 (Friday) at 10:00 am to address public complaints relating to DRAP.

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“The Board in order to ensure conformance to standards decided that validity of GMP certificate for local manufacturing will be one year for first three years for grant of Establishment License and thereafter validity will be for three years.

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Training announcement for software for import export clearance (therapeutic goods raw material).

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applicants were placed before the Enlistment Evaluation Committee (EEC) in its 93rd meeting held on 11th August, 2021 and the same have been deferred being deficient of the information / documents.

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Practel Paediatric Oral Suspension-Manufactured By M/S. Health Care Pharmaceuticals, Multan.

Practel

Zatranex Injection Reg No. 014217, Batch No.594 Manufactured By M/S. Zafa Pharmaceutical Laboratories (Pvt.) Ltd. Karachi

Zatranax-Injection-10

Drug Regulatory Authority of Pakistan

Year: 2021

Draft Guidelines On Good Pharmacovigilance Practices For Registration Holders for view Comments to be Submitted to National PV Center DRAP till 15th January, 2022

User Guide For Online Import / Export Applications Software

Drug Product Recall: Dextrose 25% Infusion (Batch# A042C21) by M/s Otsuka Pakistan Ltd, Hub, Baluchistan

Pre-Submission Screening Checklist for Biological Registration Dossier

Holding Of E-Kachehri

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

Drug Product Recall: Practel Paediatric Oral Suspension (Batch# AA008) by M/s Health Care Pharmaceuticals, Multan

Drug Product Recall: Zatranex Injection (Batch #594) By M/S. Zafa Pharmaceutical Laboratories (Pvt.) Ltd. Karachi