OpenLobby.EU
Explore

Revision of EMA fees

Public health

According to Article 86a of the European Medicines Agency founding Regulation (Regulation (EC) No 726/2004), the Commission is obliged to review the legal framework for fees payable to the Agency in relation to medicinal products for human and veterinary use and propose an update of the legal framework as appropriate. To comply with this requirement, the Commission will first carry out an Impact Assessment (including an open public consultation) to analyse various options.

Links

Public consultation

ID: 2091

Lobbying Activity

11 responses

Consultation response

European Federation of Pharmaceutical Industries and Associations, 6 Feb 2023

EFPIA welcomes the opportunity to comment on the EU Commissions EMA fees proposal. EFPIAs comments reflect those of its members in the innovative industry which extensively remit EMA fees. Exacerbated by the COVID crisis and the impact of Brexit, the EU regulatory system is experiencing significant…

Consultation response

European Federation of Pharmaceutical Industries and Associations, 15 Oct 2019

Dear Sir/Madam, Please find attached our response to the EU Commission Inception Impact Assessment on EMA Fees. Best regards, Pär Tellner Director Regulatory, Drug Development and Manufacturing EFPIA

Consultation response

MEDICINES FOR EUROPE, 7 Feb 2023

Medicines for Europes comments of the EMA fees regulation. Medicines for Europe supports a cost-based EMA fee system with a simpler fee structure. For generic medicines with very low margins, regulatory costs can be critical to maintain older products (with low to zero profitability) or supply…

Medicines for Europe backs cost-based EMA fee system with simplification

MEDICINES FOR EUROPE, 16 Oct 2019

The organization supports a cost-based fee system with simplified structure and flat annual fees to reduce administrative burden. They emphasize fees must reflect actual assessment workload and not become barriers to registering generic and biosimilar medicines.
This would reduce their administrative burden and prevent excessive costs for generic medicines.

Consultation response

Association of the European Self-Care Industry, 7 Feb 2023

Please see below the AESGP comments on the European Commission proposal on updating the rules on fees payable to the European Medicines Agency. The detailed comments are provided in the attached document. The EMA is currently funded at 86% by fees, 13% by EU contribution and 1% by other sources. It…

Consultation response

AnimalhealthEurope, 7 Feb 2023

AnimalhealthEurope supports the appropriate funding of regulatory agencies essential to the efficient regulatory control of veterinary medicinal products (VMPs). However, the proposed cost-based system for EMA fees will be too expensive for the VMP sector. The EMA is being asked to expand its role,…

Consultation response

Teva Pharmaceuticals Europe BV, 7 Feb 2023

At Teva pharmaceuticals, our mission is to improve the lives of patients across the globe. In Europe, Teva is a strategic partner of healthcare systems, producing 96% of its European generic, biosimilar and innovative portfolio in plants across 15 European countries (53% of our APIs are…

Consultation response

Association Mieux Prescrire, 15 Oct 2019

Dear Madam/Sir, Please find attached Prescrire's response to the EU Commission Inception Impact Assessment on the revision of the EMA Fee system. Best regards, Prescrire

Consultation response

Fondazione Telethon ETS, 7 Feb 2023

Fondazione Telethon (Italy) is an Italian non-profit organization that has been supporting bio-medical research on rare and genetic diseases for more than 30 years. Fondazione Telethon welcomes the opportunity to comment on the EU Commissions proposal on the revision of EMA fees. Looking ahead and…

Consultation response

European Coalition on Homeopathic and Anthroposophic Medicinal Products, 16 Oct 2019

ECHAMP welcomes this consultation and we are pleased that possible misalignment of some fees with the underlying costs will be addressed. We fully support the objective of ensuring a fair distribution of fees. We ask for your specific attention for the category of homeopathic medicinal products. We…

Consultation response

Bundesverband fuer Tiergesundheit, 1 Feb 2023

Proposal for a REGULATION amending Regulation (EU) 2017/745 and repealing Council Regulation (EC) No 297/95 and Regulation (EU) 658/2014 on fees and charges payable to the EMA - Vorschlag der Europäischen Kommission zur Anpassung der EMA-Gebühren Der verfolgte Ansatz, für die EMA auch im…