Report to the European Commission on Pharmacovigilance audit carried out in 2019
Given that national competent authorities and marketing authorisation holders are required to carry out internal audits of their pharmacovigilance systems in accordance with the guideline on Good Pharmacovigilance Practice (GVP) Module IV - Pharmacovigilance audits, on 12 September 2019 the Agency for Medicinal Products and Medical Devices (HALMED) submitted a report to the European Commission on the internal audit of its pharmacovigilance system for the period between 19 September 2017 and 12 September 2019.
The report is prepared according to the Art 101, paragraph 2 of the Directive 2001/83/EC on medicinal products for human use, setting out the obligation for Member States to carry out periodic internal audits of their pharmacovigilance systems and to submit the audit report to the European Commission no later than 21 September every two year, starting from 2013.
