About this consultation

Consultation period
2 May 2018 - 2 August 2018
Topics
Public health

Consultation outcome

All individual contributions will be published on the Commission’s website upon finalisation of the public consultation. The identity of the respondent will only be published upon active consent from the respondent (reference is made to Question 1 of the questionnaire).

See further the privacy statement attached to this consultation for information on how your personal data and contribution will be dealt with.

Target group

All citizens, administrations, associations and other organisations with an interest in the EMA fee system and its implementation are invited to contribute to this consultation.

Part of the questions are more specifically addressed to pharmaceutical industry and academia / research organisations having active experience with the operation of the EMA fee system.

Objective of the consultation

The European Medicines Agency (EMA) is the European Union’s (EU) central regulatory body operating centralised pre- and post-authorisation procedures for medicinal products for human and veterinary use across the EU and the European Economic Area (EEA). The EMA works in close collaboration with national competent authorities (NCAs) in the EU and EEA Member States. NCAs are represented in the EMA committees and working parties and in this setting they carry out assessments of medicinal products for human and veterinary use in the context of EU marketing authorisations.

The EMA is funded by EU and EEA contributions as well as fees paid by entities for obtaining and maintaining marketing authorisations and for providing other services. NCAs receive remuneration from the EMA for activities for centralised procedures at the level of the EU. The relevant rules are laid down in the fee Regulation (Council Regulation (EC) No 297/95) and its implementing rules, as well as the pharmacovigilance fee Regulation (Regulation (EU) No 658/2014). Fee incentives are provided for specific types of products (including medicines for rare diseases, medicines for children, advanced therapies, and veterinary medicines for minor use/minor species) and specific applicants and marketing authorisation holders such as micro, small and medium-sized enterprises (SMEs).

This public consultation is part of a study supporting the evaluation of the EMA fee system. The study, including the public consultation, is carried out by the consultant, RAND Europe. The consultation aims to elicit information, views and concerns of all groups having an interest in the EMA fee system and its implementation.

How to submit your response

Respondents are invited to take part in the consultation by completing the online questionnaire provided. The questionnaire is available in English, French and German, and responses can be submitted in any of the official EU languages.

Please note that in order to ensure a fair and transparent consultation process only responses received through the online questionnaire will be taken into account under this consultation.

View the questionnaire

Please click here to fill in the questionnaire.

Additional information

Transparency Register

In the interests of transparency, administrations, associations and other organisations have been invited to provide the public with relevant information about themselves by registering in the EU's Transparency Register and subscribing to its Code of Conduct. If the organisation is not registered, the submission is published separately from the registered organisations.

To register, please click here.

Protection of personal data

The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000. See also the Legal Notice and Protection of Personal Data on the Commission website.

Contributions will be published either with or without the identity of the respondent, depending on the option chosen by the respondent under Question 1 of the questionnaire. Please note that regardless the option chosen, your contribution may be subject to a request for access to documents under Regulation (EC) 1049/2001 of the European Parliament and of the Council of 30 May 2001. In such case, the request will be assessed against the conditions set out in that Regulation and in accordance with applicable data protection rules.

See further the privacy statement attached to this consultation for information on how your personal data and contribution will be dealt with.

Copyright clearance

Any submission made by you on this website represents an agreement that the data you submitted may be used by the European Commission and its contractor to support the evaluation of the EMA fee system. This means that your contributions may be published individually or be part of a synthesis and referred to as meaningful example. Following your submission you also understand that you authorise the European Commission to reproduce, translate, print, publish and make available your contributions in print and electronic format and permit others to use the content or parts of it in accordance with Commission Decision of 12 December 2011 on the reuse of Commission Documents.

Contact