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: –

  1. 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.
  2. 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.

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

http://pirims.dra.gov.pk

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.

Tender Notice for Hiring of Security Services

Drug Regulatory Authority of Pakistan invites sealed tenders from reputable security companies duly registered with Ministry of Interior/ Concerned Home Department to provide security services including deployment of security personnel at its Head Office located at Islamabad for a period of one (01) year, further extendable on satisfactory performance. The security companies must be on Active Taxpayers List of FBR and fulfill the eligibility criteria/ terms and conditions as per tender document.

2.            Interested and eligible security companies / firms may submit their bids in sealed envelopes using single stage two envelop procedure under the PPRA Rules, 2004. The bids must reach the office of undersigned latest by 2nd November, 2021 at 11:00 AM, which shall be opened at the same day at 11:30 AM in presence of representative of the bidders who may wish to be present.

3.            Tender documents containing terms and conditions can be obtained from the office of undersigned during office hours on payment of Rs.2000/- through pay order/ bank draft in favor of Drug Regulatory Authority of Pakistan Islamabad or the same can be downloaded from PPRA’s website www.ppra.org.pk or DRAP’s website www.dra.gov.pk.