
New Manufacturer’s Incident Report PMSV reporting forms - European Commission (Copy)
The European Commission has published a new reporting template for Manufacturer Incident Reports (MIR) for Serious Incidents (SI). The template will become obligatory in November 2025.

New Manufacturer’s Incident Report PMSV reporting forms - European Commission
The European Commission has published a new reporting template for Manufacturer Incident Reports (MIR) for Serious Incidents (SI). The template will become obligatory in November 2025.

Proposal for Critical Medicines Act
The European Commission has presented its proposal for a Critical Medicines Act. The main purpose of the proposed Act is to limit the EU dependence on third country sources of critical medicines and encourage domestic production.

Commission publishes Guidelines on the definition of an artificial intelligence system established by the AI Act
The European Commission has published Guidelines on the definition of an artificial intelligence system established by Regulation (EU) 2024/1689 (AI Act) file:///C:/Users/ewright/Work%20Folders/Downloads/Guidelines_on_the_definition_of_an_artificial_intelligence_system_established_by_AI_Act_VJp35Ve5WA4XFrpUSFj5ohfaBco_112455.pdf