Regulatory affairs guides
Long-form, sourced guides to the procedures EU regulatory teams run every year: how to classify a variation, how the decentralised procedure timetable works, when a renewal is due and how the sunset clause bites. Each guide cites Directive 2001/83/EC, Regulation (EC) No 726/2004, the Variations Regulation and the EMA and CMDh guidance it relies on, and ends with what the agreed 2026 EU pharma package changes.
Procedures and lifecycle
Step-by-step guides with the legal basis, the timelines and the mistakes that cost the most time.
How to classify a variation under Regulation (EC) No 1234/2008
Type IA, IA IN, IB, II or extension: the classification rules, the default to Type IB, timelines per type, grouping and worksharing, common mistakes and what Article 94 of the agreed directive changes.
ExploreThe decentralised procedure timetable, explained day by day
Validation, Day 70, the Day 105 clock-stop, Day 120, 180 and 210, the CMDh referral and the 30-day national phase, with the RMS and CMS roles, what stops the clock, how to choose an RMS and how DCP compares with MRP and the centralised route.
ExploreMarketing authorisation renewal and the sunset clause in the EU
Five-year renewal under Article 24 of Directive 2001/83/EC, the renewal dossier and the nine-month deadline, the three-year sunset clause, exemptions, and how the agreed 2026 package replaces routine renewals with unlimited validity.
ExplorePut the same questions to Workbench
Workbench answers procedure and classification questions with the legislation and guidance cited, product by product.