The European Medicines Agency (EMA) charges and collects fees from pharmaceutical companies for carrying out pharmacovigilance activities.
The adoption of Regulation (EU) No 658/2014 enables the EMA to collect fees to cover the costs for the conduct of pharmacovigilance activities as assigned to it by the 2010 pharmacovigilance legislation that became applicable in July 2012. Consequently, marketing-authorisation holders of medicinal products for human use are levied a fee for the conduct of pharmacovigilance activities by the Agency. These activities include the scientific assessment performed by rapporteurs in the framework of Union-wide pharmacovigilance procedures; the monitoring of literature cases and the improved use of information technology tools.
The Agency charges two types of fees for pharmacovigilance activities:
- Procedure-based fees:The Agency charges procedure-based fees for the single assessment of periodic safety update reports (PSURs), for assessment of post-authorisation-safety-study (PASS) protocols and study results, and for pharmacovigilance-related referrals. The Agency started charging for these procedures from 26 August 2014.
- Annual fee: An annual fee is charged for nationally authorised medicines only, with respect to the monitoring of literature cases and the improved use of information technology tools. An annual fee becomes due on 1st of July of every year in respect of that calendar year as from 2015.
The income from procedure-based fees is used to finance the related procedure including the remuneration of the national competent authorities (NCAs) for the scientific assessment carried out by the rapporteurs of the Pharmacovigilance Risk Assessment Committee (PRAC).
The income from annual fees supports the implementation and maintenance of measures from the 2010 pharmacovigilance legislation, including:
- literature monitoring;
- the European medicines web portal;
- enhanced functionalities for EudraVigilance;
- a repository of PSURs.
These activities directly benefit marketing-authorisation holders by reducing administrative burden, simplifying reporting and streamlining processes.
Introduction to pharmacovigilance fees
EMA has prepared a series of short videos to provide further information on the pharmacovigilance fees payable to the Agency and these videos can be viewed below.
The following topics are covered:
- Overview of pharmacovigilance fees
- Introducing the ‘chargeable unit’
- Advice notes
- Fee reductions and fee exemptions
- Financial matters
Calculating the fee
The basis of calculation of pharmacovigilance fees for PSURs, pharmacovigilance referrals and the annual fee is the chargeable unit (CU), which is defined in Article 2 of Regulation (EC) 658/2014 as a unique combination of the following dataset derived from information on all medicinal products authorised in the Union held by the Agency, and consistent with the obligation of marketing-authorisation holders referred to in points (b) and (c) of Article 57(2) of Regulation (EC) No 726/2004 to submit such information to the database referred to in point (l) of the second subparagraph of Article 57(1) of that regulation:
- Name of the medicinal product, as defined in point 20 of Article 1 of Directive 2001/83/EC;
- marketing-authorisation holder;
- the Member State in which the marketing authorisation is valid,
- active substance or a combination of active substances- and
- pharmaceutical form.
Please refer to the Calculating 'chargeable units' for pharmacovigilance fees document for further guidance on how 'chargeable units' are derived from medicinal product information held within the Article 57 database.
Please note that, for PASS procedures, a flat amount to be paid in two instalments is applied.
Fee amounts to be levied on marketing-authorisation holders
|Pharmacovigilance fee||Fee amount||Fee split|
|Periodic safety update report|
€19,500 due at date of start of procedure.
|Fee is divided among marketing-authorisation holders involved in the procedure by charging them proportionately to the respective number of chargeable units held by each marketing authorisation holder.|
|Post-authorisation safety study|
€43,000 split into in two instalments:
|Fee is divided among all marketing authorisation holders having the obligation to produce the study by charging equal amounts to each marketing authorisation holder.|
€179,000* if it only concerns 1 or 2 active substances.
+ €38,800 for every additional active substance or combination.
€295,400 maximum fee.
Due at the start date of the procedure.
|Fee is divided among marketing authorisation holders involved in the procedure by charging them proportionately to the respective number of chargeable units held by each marketing authorisation holder.|
|Annual fee for information technology systems and literature monitoring||€67 per chargeable unit due on 1st July every year.||N/A|
* If the procedure involves one substance or one combination of substances and one marketing-authorisation holder, the Agency shall levy a reduced amount of the fee on that marketing authorisation holder (two thirds of the basic fee).
Fee reductions and exemptions
Fee reductions and exemptions are in place for Micro-, small- and medium-sized-enterprises (SMEs) and for certain categories of medicines such as generics, well-established use, homeopathic and herbal products.
The below table details the various fee reductions and exemptions applicable per pharmacovigilance fee type:
|Pharmacovigilance fee||Micro enterprises||Small and medium-sized enterprises||Generics, well-established use, authorised homeopathic and herbal medicinal products|
|Periodic safety update report||Exempt||60% of the applicable fee or share of fee||Full fee*|
|Post-authorisation safety study||Exempt||60% of the applicable fee or share of fee||Full fee|
|Pharmacovigilance-related referral||Exempt||60% of the applicable fee or share of fee||Full fee|
|Annual fee for information technology systems and literature monitoring||Exempt||60% of the applicable fee||80% of the amount applicable to the chargeable units corresponding to those products.|
* A full fee applies to generics, well-established use, homeopathic and herbal products when they are within the scope of the procedure, as specified in the EURD list.
Prior to issuing an invoice, the Agency provides marketing-authorisation holders with an opportunity to review the information recorded in the Article 57 database by supplying the qualified person for pharmacovigilance with an advice note. The advice note contains the line listing of the chargeable units and a reference to the related products (as recorded in the Article 57 database) as well as regulatory background and electronic submission guidance.
Paying your fees
Information and guidance on invoicing, terms and conditions of payment and how to set up a customer account with the Agency can be found on our How to pay page.
Contacting the Agency about fees
If you have a query related to pharmacovigilance fees, please visit the Pharmacovigilance fees: questions and answers page.
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Related EU legislation
- Regulation (EU) No 658/2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use
- Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
- Explanatory note on pharmacovigilance fees payable to the European Medicines Agency (10/03/2015)
- Calculating 'chargeable units' for pharmacovigilance fees as specified in Regulation (EU) No 658/2014: guidance on how 'chargeable units' are derived from medicinal product information held within the 'Article 57' database (21/07/2015)