Regarding application of annual pharmacovigilance fee

Regarding application of annual pharmacovigilance fee

Compliance with pharmacovigilance requirements is a mandatory condition for all marketing authorisation holders in accordance with EU legislative acts. In accordance with the Section 10, Article 18 of the Pharmaceutical Law the State Agency of Medicines (hereinafter - the Agency) performs the functions of pharmacovigilance, including supervision of the adverse effects caused by the use of medicinal products, as well as creates and maintains a database in relation to supervision of safe use of medicinal products. By ensuring the aforementioned functions the Agency streamlines the requirements laid down for supervision of the safety of medicinal products, as well as establishes a team of competitive experts to ensure these tasks, therefore, a paid service has been established for the performance of pharmacovigilance related functions - an annual pharmacovigilance fee for medicinal products authorised through the national procedure (including mutual recognition and decentralised procedure). The annual pharmacovigilance fee includes: registration of adverse drug reactions, uploading adverse drug reaction reports to the EudraVigilance database, data exchange, evaluation and monitoring of data, forwarding adverse drug reaction reports to the World Health Organization, conduct of good pharmacovigilance practice compliance inspections of the marketing authorisation holder, implementation of strategic tasks for EU signal management and risk management, including exchange of pharmacovigilance data in the EPITT system, introduction of EU signal identification principles, signal assessment, pharmacovigilance system audits, improvements in the electronic systems of the Agency for electronic reporting, approval of additional risk minimisation measures (direct healthcare professional communication, educational materials, special programs) for communication with healthcare professional organisations, individual healthcare professionals, patients, preparation and publication of methodological guidelines for marketing authorisation holders, as well as other pharmacovigilance related activities.

The annual pharmacovigilance fee is not applied to parallel imported and unauthorised medicines. The State Agency of Medicines does not apply the annual pharmacovigilance fee to medicines authorised in the centralised procedure, because for these medicines the amount and procedure for the payment of the fee regarding pharmacovigilance activities to the European Medicines Agency has been laid down in the Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 May 2014 on fees payable to the European Medicine Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use.

In addition, the annual pharmacovigilance fee will not be applied to homeopathic and traditional herbal medicines, because the safety profile of these medicines is well established and the number of adverse reaction reports is significantly lower (no reports regarding serious adverse reactions have been received).

The annual pharmacovigilance fee is applied in accordance with the Cabinet of Ministers Regulation No 873 of 17 September 2013 "State Agency of Medicines Publicly Available Paid Service Price List”.