Response to Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices as regards simplification and burden reduction

6 Oct 2025

Response to Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795

2 Jul 2025

Response to Critical Medicines Act

19 Feb 2025

Response to COMMISSION IMPLEMENTING REGULATION (EU) …/... laying down rules for the application of Regulation (EU) 2021/2282 of the European Parliament and of the Council as regards the management of conflicts of interest in the joint work of the Member State Coordination Group on Health Technology Assessment and its subgroups

26 Jun 2024

Response to COMMISSION DELEGATED REGULATION (EU) …/... amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use

28 Feb 2024

Response to Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006

8 Nov 2023

Meeting with Tilly Metz (Member of the European Parliament) and 10 other interest representatives

10 Oct 2023 · Pharma Package

Response to Commission Delegated Regulation supplementing Directive 2001/83/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council on the examination of variations to the terms of marketing authorisations for medicinal products for human use and amending Commission Regulation (EC) No 1234/2008 of 24 November 2008

21 Sept 2023

Meeting with Maria-Manuel Leitão-Marques (Member of the European Parliament, Shadow rapporteur) and 7 other interest representatives

20 Apr 2023 · Product Liability Directive

Meeting with René Repasi (Member of the European Parliament, Shadow rapporteur)

4 Apr 2023 · Exchange of views on the Product Liability Directive/ Produkthaftungsrichtlinie (PLD) - Staff Level

Meeting with Pascal Arimont (Member of the European Parliament, Rapporteur) and 2 other interest representatives

14 Mar 2023 · Revision of the Product Liability Directive

Meeting with Marc Botenga (Member of the European Parliament) and 3 other interest representatives

25 Jan 2023 · Covi committee

Meeting with Sara Cerdas (Member of the European Parliament) and 4 other interest representatives

20 Jan 2023 · COVI Committee hearings and report

Response to Evaluation and Revision of Regulation (EC) No 726/2004 and Directive 2001/83/EC

27 Apr 2021

Response to Proposal for a Regulation of the European Parliament and of the Council establishing a European Health Emergency Response Authority (HERA)

23 Feb 2021

Response to Proposal for an EP and Council Regulation on orphan and paediatric medicinal products

5 Jan 2021

Response to Commission Communication on a Pharmaceutical Strategy- Ensuring sustainable innovation and the availability and affordability of medicines and medical technologies for citizens

7 Jul 2020

Response to Proposal for an EP and Council Regulation on fees charged by the European Medicines Agency (EMA), including remuneration paid to National Competent Authorities (NCAs), for activities related to obtaining and maintaining marketing authorisations for medicinal products for human and veterinary use.

15 Oct 2019