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.. Read more