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The Union Product Database: What Veterinary Marketing Authorisation Holders Must Keep Current
The Union Product Database sits at the centre of Regulation (EU) 2019/6. Launched in January 2022 and managed by the European Medicines Agency, it is[…]
Regulation (EU) 2019/6: The Veterinary Medicines Rulebook, Four Years On
Since 28 January 2022, veterinary medicines across the European Union have been governed by Regulation (EU) 2019/6, a directly applicable regulation that repealed Directive 2001/82/EC[…]
From XEVMPD to PMS: The IDMP Data Deadlines Now on Your Calendar
ISO IDMP has spent a decade being described as a project for the IT department. That description stops working in December 2026, when the European[…]
Medical Device Reimbursement in Greece: From CE Mark to EOPYY Payment
A CE mark lets you place a device on the Greek market. It does not get anyone to pay for it. Reimbursement in Greece runs[…]
EudraGMDP: What the Public Record Says About Your Sites
EudraGMDP is the European database of manufacturing and import authorisations, GMP certificates and statements of non-compliance with GMP. It is maintained by EMA, and a[…]
PDUFA VIII: Why the FDA’s Next User-Fee Cycle Matters to EU Companies
The FDA holds a hybrid public meeting on 16 September 2026 on reauthorisation of the Prescription Drug User Fee Act, with comments open until 16[…]
EMA’s NAMs Pilot: Submitting Non-Animal Data Outside a Dossier
On 1 September 2026 EMA launched a voluntary data submission pilot for New Approach Methodologies — the organ-on-chip systems, human tissue models, organoids and computational[…]
The Revised EU Guideline on the Chemistry of Active Substances
EMA adopted a revised Guideline on the chemistry of active substances (EMA/CHMP/QWP/49484/2026), published on 20 March 2026 and now the current effective version. It is[…]
PRAC Opens an EU-Wide Review of Injectable Iron Medicines
On 4 September 2026 EMA announced that its safety committee, PRAC, has started a review of injectable iron-containing medicines over the risk of hypophosphataemia —[…]
Referral Procedures: When Your Medicine Is Reviewed EU-Wide
A referral takes a medicine out of the hands of its marketing authorisation holder and puts it in front of the entire European regulatory network.[…]