Medical Devices
11 jun 2026
EUDAMED becomes mandatory from 28 May 2026: what to do now
From 28 May 2026 the first four EUDAMED modules become mandatory under MDR and IVDR. Here is what...
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New EU rules for food supplements and cosmetics: what is changing
Three EU regulatory changes for food supplements and cosmetics: harmonised nutrient levels, Belgian rules, and the Omnibus VIII CMR ban from 1 May 2026.
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Pharmacovigilance
11 jun 2026
ICH E2D(R1): new standards for post-approval safety data
The revised ICH E2D(R1) guideline is now in effect in the EU. Here is what changes for post-approval...
Pharmacovigilance
11 jun 2026
New GVP guidance for pregnant and breastfeeding women
The EMA has issued new GVP guidance on medicines used by pregnant and breastfeeding women. Here is what...
GDP & Distribution
11 jun 2026
Stock Monitoring Tool: the 1 July go-live looks set to be postponed
An early heads-up: the FAMHP’s Stock Monitoring Tool, due to go live on 1 July 2026, looks set...
Regulatory Affairs
11 jun 2026
Article 10 and the RIP role: takeaways from the FAMHP info session
Several MPCA colleagues attended the FAMHP’s info session on Article 10. Here is what the updated guidance means...
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