In exercise of the powers conferred by sub-section (1) of section 20 of the Drug Regulatory Authority of Pakistan Act,2012 (XXI of 2012), read with sub-rule (3) of Rule 4 of the Drug Regulatory Authority of Pakistan (Fee and Levy) Rules, 2022, the regulatory fees of various functions has been notified. The Notification as under:-
SROs
SRO 1710; MRP Fixation of Drugs
Model List of Essential Medicines 2023 (S.R.O. 1423 of 2023)
SRO.1092(I)/2023 dated 22nd Aug, 2023: Fixation of Maximum Retail Price (MRP) of Drugs
S.R.O. 1067(I)12023: Schedule of Charges for GMP Certificate and Panel Inspection
SRO.769(I)/2023 dated 23rd June, 2023: Fixation of Maximum Retail Price (MRP) of Drugs and Biologicals
SRO 685(I)/2023 dated 09-06-2023: Amendments in the Bio Study Rules, 2017
The Drug Regulatory Authority of Pakistan, with the Federal Government’s approval, has made amendments to the Bio-Study Rule 2017. Through this amendments, the Application Form (Form-IIA) for BA/BE Studies has been revised to rationalize the requirement for submission of the reference product’s Certificate of Pharmaceutical Products (CoPP). The Notification issued in this regard is as under:-
SRO 678(I)/2023 Amendments in the Drug Pricing Policy-2018.
SRO.649(I)/2023: MRP fixation of Cardiac Stents
Drug Regulatory Authority of Pakistan with approval of the Federal Government, in exercising its powers conferred by subclause (vii) of clause (c) of section 7 of the Drug Regulatory Authority of Pakistan Act2012 (XXI of 2012) readwith section 1 2 of the Drugs Act, 197 6 (XXXI of 197 6) has notified the maximum retail prices of cardiac stents as specified hereunder:-