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Report to the European Commission on Pharmacovigilance audit carried out in 2013

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 17 September 2013 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 1 July and 16 September 2013.

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 2013 and every two years thereafter.

Internal audit was carried out in the initial period after the accession of the Republic of Croatia to the EU of HALMED’s activities as a new competent authority that needs to comply with the EU pharmacovigilance legislation. To that end an action plan has been prepared including all the requirements listed in the good pharmacovigilance practices within HALMED’s units responsible for pharmacovigilance activities. The achievement of defined goals was evaluated during the audit, whose details are listed in the report.

Download of the report (.pdf)