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Regulatory Watch

MPCA's regulatory watch: the regulatory and legislative changes that matter for pharma, medical devices, supplements and cosmetics in the Benelux.

MPCA International - New EU rules for food supplements and cosmetics Cosmetics
18 jun 2026

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...

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MPCA International - EUDAMED mandatory from 28 May 2026 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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MPCA International - New GVP guidance for pregnant and breastfeeding women 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...

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MPCA International - ICH E2D(R1) post-approval safety data 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...

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MPCA International - Belgium's Stock Monitoring Tool go-live postponed 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...

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MPCA International - Article 10 and the Responsible Person for Information and Publicity (RIP) in Belgium 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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