Summary
A major reform of EU pharmaceutical laws to improve medicine availability, fight antibiotic resistance, and modernize the European Medicines Agency. 9 10.04.2024
Report
health
economy
science
environment
human rights
public safety
administrative law
administrative reform
public administration
business and competition
Key points
- The regulation updates the procedures for authorizing and supervising medicines used by humans across the EU.
- New mechanisms are introduced to fight antimicrobial resistance, including financial rewards for developers of new antibiotics.
- Market exclusivity for medicines treating rare diseases is set at specific durations, such as eleven years for those addressing high unmet needs.
- Companies must implement shortage prevention plans to ensure a steady supply of medicines.
Vote
PPE (100)
S&D (69)
Renew (39)
PfE (32)
Verts/ALE (31)
ECR (28)
The Left (14)
NI (7)
ESN (4)
Total
228 In favor40 Against8 Abstained48 Absent
Vote
PPE
S&D
Renew
PfE
Verts/ALE
ECR
The Left
NI
ESN
Total
Speeches
32 Speeches in total
Pro
Contra
Henna VIRKKUNEN
PPE
Documents (PDFs)
DRAFT OPINION on the 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
DRAFT REPORT on the 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
OPINION on the 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
REPORT on the 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
Opinion on the Proposal for a Regulation 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
Opinion on Opinion on the Commission proposal on a Regulation of the European Parliament and of the Council on for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency COM(2023)0193; (2023/0131(COD)).
Union procedures for the authorisation and supervision of medicinal products for human use and rules governing the European Medicines Agency
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