Pharmacovigilance fees – Information for companies on fees for safety monitoring of medicines

EMA document explains how fees are calculated and collected 

(10/03/2015)

The European Medicines Agency (EMA) has published an explanatory note on the fees payable to the Agency for its monitoring of the safety of medicines authorised in the European Union (EU). The document describes types of fees, fee exemptions and explains how the Agency charges and collects fees from marketing-authorisation holders of medicinal products for human use.

The fees are based on the pharmacovigilance legislation adopted by the European Parliament and the Council of EU that stipulates that EU pharmacovigilance activities for medicines should be financed by the marketing-authorisation holders.

In August 2014, EMA started charging fees for pharmacovigilance procedures, including the assessment of periodic safety update reports, and the assessment of post-authorisation-safety-study (PASS) protocols and study results, and forpharmacovigilance-related referrals. These fees are charged to companies whose medicines, whether centrally or nationally authorised, are included in these procedures.

From 1 July 2015 and annually thereafter, the Agency will charge and collect annual fees for nationally authorised medicines. Annual fees related to centrally authorised products are covered by the Regulation No 297/95 for centrally authorised products.

In addition to the explanatory note published today, the Agency will provide companies with the opportunity to review the information on their medicines held by EMA on which annual fees are calculated. The qualified person for pharmacovigilance will be supplied with an ‘advice note’ which will contain the line listing of their chargeable units in April 2015.

The income from the pharmacovigilance procedural fees will be used to remunerate national competent authorities (NCAs) for the scientific assessment carried out by the rapporteurs of EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). The income from the pharmacovigilance annual fees will be used to cover some of thepharmacovigilance-related costs of the Agency such as the monitoring of scientific literature for cases of adverse drug reactions and the improved use of information technology tools to support the collection, management, analysis and availability ofpharmacovigilance data and information on medicines.

More information on pharmacovigilance fees and regular updates are available on a dedicated EMA webpage.