Draft Format for Submission of Data under the Ethical Marketing to Healthcare Professionals Rules 2021.

The Ethical Marketing to Healthcare Professionals Rules have been notified vide SRO 1472(I)/2021 on the 12th of November 2021 by the Drug Regulatory Authority of Pakistan. These rules have been promulgated to make the interaction between companies and healthcare professionals transparent, free from corrupt practices and to facilitate medical decisions making in the best interest of the patient.

The aforementioned rules require therapeutic goods companies to submit marketing expenditure details under rule 14(2) and annual compliance certificate under rule 13(h). Subsequent to the notification of these rules, DRAP has drafted an implementation strategy which requires systematic data submission.

The implementation strategy is aimed at harmonized data submissions by stakeholders in a systemic manner, we have drafted followings formats for data submission:-

Comments from therapeutic goods companies, healthcare professionals and relevant stakeholders are invited on the draft documents within 15 days. These comments along with justification are to be submitted using prescribed format, (further information on comments submission can be accessed on this link). Comments and suggestions can be forwarded via email to drap.pharmacygmail.com, copying at aqsa.hashmidra.gov.pk , or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, Islamabad.