Ministry of National Health Services Regulations & Coordination Islamabad
Ministry of National Health Services Regulations & Coordination Islamabad
Note: “Comments/input within 15 days is requested from relevant stakeholders & the general public etc.(Pharmacy Services Division)”
Draft Guidelines on Responsible Use of Antimicrobials
Note: “Comments/input within 15 days is requested from relevant stakeholders in use of antimicrobials including healthcare delivery organizations, healthcare professionals and healthcare professional councils i.e. Pakistan Medical Commission Council, Pakistan Pharmacy Council and Nursing Council, Pharma Bureau, Pakistan Pharmaceutical Manufacturers Association (PPMA) etc”
Notice for Importers / Pharmaceutical Companies for creation of user accounts on PIRIMS
All the importers /Pharmaceuticals Companies are advised to create login registrations at PIRIMS up to 30th November 2020, Your provisional username and passwords will be issued after the registration process in PIRIMS Software.
GUIDANCE DOCUMENT FOR SUBMISSION OF APPLICATION ON FORM 5-F (CTD) FOR REGISTRATION OF PHARMACEUTICAL DRUG PRODUCTS FOR HUMAN USE. [12 OCT, 2020]
SRO-967(I)2020 [05 OCT, 2020]
DRAFT GUIDE LINES FOR COMPLAINT HANDLING [06 OCT, 2020]
FAST TRACK REGISTRATION OF FLUDROCORTISONE [15 Sep, 2020]
Online Hands On Training of Pakistan Integrated Regulatory Information Management System(PIRIMS) [10 Sep, 2020]
Reaching Out to public through holding of E kachehri [09 Sep, 2020]
Registration of Potassium Iodide tablet as registered drug [03 Sep, 2020]
Tender for Stationery Item 2020-21, DRAP [02 Sep, 2020]
Notification for Designated official under right of access to information Act,2017(XXXIV) [25 Aug, 2020]
Deficiency letter of all deferred products in 80th meeting of EEC held on 26-6-2020- Part-2.pdf [24 Aug, 2020]
National Essential Medicines List 2020 [12 Aug, 2020]
Minutes of 79th Meeting of EEC held on 14th May, 2020 [06 Aug, 2020]
Minutes of 78th Meeting of EEC held on 23rd April, 2020 [06 Aug, 2020]
Minutes of the 17th Meeting of the Medical Device Board (MDB) held on 13th July, 2020 [30 Jul, 2020]
Voluntary Recall of Herceptin Solvent Vials-20ml Batch Number: N7396B04 Due to Glass Particles in Solvent Vials [17 Jul, 2020]
Drug Pricing Policy 2018 as Ammenended Vide Notification No.F.11-2/2020-DD(P) Dated: 15 Jul, 2020 [17 Jul, 2020]
Notification - Labelling Requirements for H&OTC Products [02 Jul, 2020]
Donation of COVID-19 Convalescent Plasma [01 Jul, 2020]
Checklist for No Objection Certificate for import of unregistered/ not available medical device(s) under medical devices rules, 2017 [25 Jun, 2020]
Notification - for maximum retail price (MRP) of Remdesivir [22 Jun, 2020]
Notification for want of information with respect to deferred products in 79th meeting of EEC held on 14 May, 2020 [16 Jun, 2020]
Priority Approval/Registration of Drugs Remdesivir and Tocilizumab During the COVID-19 pandemic [15 Jun, 2020]
Notification F.No.4-2/2017-DD(H&OTC):- Guidelines for export facilitation of H&OTC products [11 Jun, 2020]
Minutes of 294th meeting of Registration Board [25 May, 2020]
Tender Document Supply/ Installation of Procurement of Desktop Computers, MFP Network Printers / Copiers & Mobile Tablet [04 May, 2020]
Advisory Reminder of Risk of Serious Side Effects with Chloroquine and Hydroxychloroquine During the COVID-19 [30 Apr, 2020]
Guidelines for Enlistment of Homeopathic Combinations [21 Apr, 2020]
Letter of cases of sanitizers Permitted in 77th meeting of EEC held on 15th April, 2020 [18 Apr, 2020]
Letter of cases of sanitizers Rejected in 77th meeting of EEC held on 15th April, 2020 [18 Apr, 2020]
Letter of cases of sanitizers Deferred in 77th meeting of EEC held on 15th April, 2020 [18 Apr, 2020]
Safety Alert of Falsified Chloroquine Products Circulating in the WHO Region of Africa [15 Apr, 2020]
Letter of cases of sanitizers permitted in 76th meeting of EEC held on 10th April, 2020 [14 Apr, 2020]
Letter of cases of sanitizers rejected in 76th meeting of EEC held on 10th April, 2020 [14 Apr, 2020]
Letter of cases of sanitizers deferred in 76th meeting of EEC held on 10th April, 2020 [14 Apr, 2020]
Safety Alert of Falsified Medical Products, including In Vitro Diagnostics, that claim to Prevent, Detect, Treat or Cure COVID-19 [14 Apr, 2020]
Letter of Permission to Prepare Hand Sanitizers [10 Apr, 2020]
Deferred Applications of Hand Sanitizers [10 Apr, 2020]
Rejected Applications of Hand Sanitizers [10 Apr, 2020]
Notification regarding Hand Sanitizer [06 Apr, 2020]
Safety Alert Serious Mental Health Side Effects with Asthma and Allergic Drugs MONTELUKAST [06 Apr, 2020]
Advisory Ensuring prescription based sale of CHLOROQUINE PHOSPHATE containing dosage forms [24 Mar, 2020]
Auction Notice - Old Machinery and Furniture Items [18 Mar, 2020]
Advisory - Postponement of Conferences, Seminars, Symposium, Workshops and Other Meeting involving Large Gathering [17 Mar, 2020]
Monthly progress report of Licensing Division for the period from 01-11-2019 to 30-11-2019 [16 Mar, 2020]
Safety Alerts of falsified antimalarials in West and Central Africa displaying an outdated WHO essential drugs programme logo [13 Mar, 2020]
Minutes of 293 Meeting of Registration Board [21 Feb, 2020]
Establishing Regulatory Pathway of Licensing System: A Progressive Approach
This document has been shared for initial consultation with our stakeholders. Please forward your comments on sultanghani1940@gmail.com by 26th February, 2020 [21 Feb, 2020]
Provisional List of Registered & Enlisted Medical Devices for Import [19 Feb, 2020]
Provisional List of Registered & Enlisted Medical Devices for Local Manufacture [19 Feb, 2020]
Invitation to bid for Photocopies of Official Documents on need basis - Closing Date: February 20, 2020 [06 Feb, 2020]
Date wise Provisional List of Application for Provisional Enlistment of Homeopathic products [04 Feb, 2020]
Date wise Provisional List of Applications for Provisional Enlistment of Herbal/Unani products [04 Feb, 2020]
Minutes of 272 meeting of the Central Licensing Board (CLB) [30 Jan, 2020]
Notification of Members of the Appellate Board [16 Jan, 2020]
S.R.O. 1571(I)/2019 Notification of CDL for testing the quality, safety and performance of certain medical devices [13 Jan, 2020]
Costing and Pricing S.R.O 09(I)/2020 [07 Jan, 2020]
Costing and Pricing S.R.O 913(1)/2017 [03 Jan, 2020]
Tender documents supply/ installation of hardware (server, scanners & barcode printers) [27th Dec, 2019]
S.R.O. 1460(I)/2019 Amendments in the Drugs (Licensing, Registration and Advertising) Rules, 1976 [29th Nov, 2019]
List of valid Drug Manufacturing Units operating in Pakistan [15th Nov, 2019]
Guidelines for the Conduct of Clinical Trial - 1st Edition [14th Nov, 2019]
List of renewal application of year 2018 deferred by Registration Board for the rectification of shortcomings [13th Nov, 2019]
Invitation to Bid (For Photocopies of Documents/Old Record) [11th Nov, 2019]
Alert Of Falsified Quinine Bisulphate: Circulating In Uganda And Quinine Sulphate Circulating In Central African Republic And Chad [8th Nov, 2019]
Draft Guideline for PRIORITY REVIEW AND ACCELERATED APPROVAL OF REGISTRATION / MARKET AUTHORIZATION (1st Edition)
["Stakeholders may submit their comments to Division of PE&R within fifteen days (till date: 15-Nov-2019) on the following email address: addl-dir.pe.reg@dra.gov.pk"]
[07th Nov, 2019]
Draft Guideline for PRIORITY REVIEW AND ACCELERATED APPROVAL OF REGISTRATION / MARKET AUTHORIZATION (1st Edition)
["Stakeholders may submit their comments to Division of PE&R within fifteen days (till date: 15-Nov-2019) on the following email address: addl-dir.pe.reg@dra.gov.pk"]
[29th Oct, 2019]
List of Federal Inspector of Drugs [04th Oct,2019]
CTD- Pre Submission Screening Checklist [29th Sep,2019]
Training Manual of IRIMS [1st Aug,2019]
