Regulatory guides

Practical EU regulatory source maps

Focused checklists for common EU post-authorisation and eSubmission questions, linked to the official sources that must be checked at the point of use.

EU variation classification: IA, IB, II or extension?A source-first sequence for classifying a proposed post-authorisation change before planning the evidence, procedure and timetable.EU eCTD Module 1: what to check before submissionA practical completeness check for regional administrative content, sequence metadata and current EU eSubmission requirements.MRP/DCP variations: a pre-submission checklistHow to organise classification, grouping, Member State requirements and product-information work before an MRP variation starts.Centralised procedure variations: the source map for MAHsA compact map of the legal, classification, EMA procedural and eSubmission sources used to prepare a centralised post-authorisation change.Nitrosamine risk assessment for EU submissionsHow the three-step EU nitrosamine exercise is structured, what belongs in Module 3, and the gaps that most often send a risk evaluation back for rework.Elemental impurities: making an ICH Q3D assessment hold upThe component-by-component logic behind a Q3D risk assessment, how the numbers are scaled to your daily dose, and what belongs in 3.2.P.5.6 rather than in a supplier folder.ASMF or CEP: documenting the active substance in an EU dossierHow the two active-substance documentation routes differ in practice, what the applicant still owes in either case, and the reference errors that stall validation.