Responsibilities relating to Pharmacovigilance (PV)

Responsibilities relating to pharmacovigilance (PV):

  • To ensure that the Marketing Authorization Holder has the appropriate PV system in place to have an overview of the safety profile for the products for which the company holds the Marketing Authorization.

  • The implementation and management of  pharmacovigilance system in the company which holds the Marketing Authorization to  ensure that all information relating to suspected adverse reactions to medicinal products are collected and processed to be available  in a precise location in the DGDA.

  • The preparation for the attention of the competent authorities of notification of serious adverse effects (ICSRs), periodic safety reports (PSURs) and reports on PMS safety;

  • The making available; at the request of DGDA, of any information necessary to evaluate the benefit / risk balance of medicines, including information relating to PMS.

  • To ensure that the PV system is working correctly, which includes the preparation and submission of expedited and periodic safety update report to guarantee the highest standard of public safety is maintained.

  • To maintain the operation of Database, SOPs, assessing training needs and preparation for audits.

  • Being the single contact point with authorities on pharmacovigilance, 24/7;

  • Being the contact point of the MA holder as part of pharmacovigilance inspections.

Qualified Person Responsible for Pharmacovigilance (QPPV)

Name of QPPV: Dr. Afroza Akhter
Address of Site Where QPPV Is Based:
¼, Kallayanpur, Mirpur Road Dhaka-1207, Bangladesh.
Email :
Helpline No: +88 01799998997
Backup in the Absence of the QPPV: Deputy QPPV: Dr. Maruf Mahadi Hasan