Amendments in the Medical Devices Rules, 2017 (SRO 1500 (I) 2021)

S.RO.1500(I)/2021.- In exercise of the powers conferred by section 23 of the Drug Regulatory Authority of Pakistan Act,2012 (XXI of 2012), the Drug Regulatory Authority of Pakistan, with approval of the Federal Government, is pleased to direct that the following amendments shall be made in the Medical Devices Rules, 2017, namely:-

 In the aforesaid Rules,-

(a) in rule 6, in sub-rule (l).-

(i) for clause (c), the following shall be substituted, namely;- “(c) the manufacturing shall be conducted under the active supervision of competent technical staff, who shall be in-charge of production, a whole time employee of the manufacturer and having relevant qualification and experience as deemed appropriate by the MDB;”; and

(ii) for clause (e), the following shall be substituted, namely:- “(e) the in-charge of quality control shall be a whole-time employee of the manufacturer and shall possess relevant qualification and experience as deemed appropriate by the MDB;”; and

(b) in rule 63, in sub-rule (3), expression after the words “omit any”, the words “Form or” shall be inserted.

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