Notice on pharmacovigilance fees payable for centrally and nationally authorised medicines
11.03.2015
The European Medicines Agency (EMA) has published on its webpages the explanation for fees payable to the EMA for monitoring the safe use of medicinal products authorised in the EU. This document describes the types of fees and exemptions from them and the procedure by which the EMA collects and charges fees from marketing authorisation holders of medicinal products.
Fees are based on the Pharmacovigilance Legislation adopted by the European parliament and the Council of the EU stipulating that the EU pharmacovigilance activities are paid by marketing authorisation holders.
In August 2015, the EMA started charging fees for pharmacovigilance activities, including the assessment of Periodic Safety Update Reports (PSURs) and the assessment of protocols and results of post-authorisation safety studies (PASS), and for pharmacovigilance-related referrals. These fees are charged to companies, whose medicinal products are either authorised via centralised or national procedure.
As of 1st July 2015, and afterwards once a year the EMA will charge and collect annual fees for nationally authorised medicines. The annual fees for centrally authorised products are set out in the Regulation (EC) 297/95 for centrally authorised medicines.
With fees explanation on the EMA webpages, companies will have a possibility to view the EMA’s information on annual fees that concern their medicines. The list of chargeable items will be delivered to qualified persons for pharmacovigilance in April 2015.
Revenues from fees payable for pharmacovigilance procedures will be used as remuneration for national competent authorities for scientific assessments conducted by rapporteurs of the EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC). Revenues from Pharmacovigilance annual fees will be used to cover parts of the EMA’s costs for pharmacovigilance, such as adverse reactions scientific literature search and the improved use of information technology tools in collecting, managing, analysis and availability of pharmacovigilance data and information of medicines.
More information on pharmacovigilance fees is available on the EMA webpages.
We remind marketing authorisation holders that in addition to the EMA pharmacovigilance fee, the HALMED annual pharmacovigilance fee shoull also be paid to finance the HALMED’s national obligations as a competent authority for medicines in Croatia, or the following HALMED’s activities laid down in the respective legislation:
- receipt, processing and scientific review of spontaneous suspected adverse reaction reported from healthcare professionals/users of medicines in Croatia
- maintenance of the information system necessary for monitoring the safe use of medicines on the market:
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- national medicines database
- local maintenance of EudraVigilance Gateway (link to the European database of all adverse reactions)
- maintenance of the system towards marketing authorisation holders
- maintenance of the system towards the World Health Organisation (WHO)
- electronic system for reporting adverse reactions from healthcare professionals and patients
- detection of safety signals at the national and EU level
- work of HALMED’s representatives in global institutions responsible for monitoring of medicines safety, i. e. in the International WHO pharmacovigilance programme etc
- work of HALMED’s representatives in European bodies responsible for safe use of medicines (parts of costs are paid from the EMA pharmacovigilance fees and parts from HALMED’s pharmacovigilance fees)
- work in referral procedures as a concerned member state in EU authorisation procedures
- providing information to healthcare propfessionals, patients and marketing authorisation holders on safety issues
- maintenance of the 24h rapid alert system on adverse reactions and quality defects that may result in withdrawals due to safety concerns
- approval procedure for local qualified person for pharmacovigilance and its deputy
- preparation of documentation for safety issue that are subject to discussion at the PRAC meetings
- procedure for obtaining scientific opinions from external experts as a base for participating in EMA’s committees
- work of the HALMED’s Committee for safe use of medicines
