Type II Variation (EU)
A significant change to the terms of an existing EU marketing authorisation that requires regulatory assessment before implementation. Examples include adding a new indication, changing the dose, or updating contraindications. Type II variations are the EU equivalent of US supplemental applications.
Technical Context
Type II variations are significant changes to the marketing authorisation requiring CHMP assessment. Examples: new indication, new dosage form, new route of administration, significant safety update, and major manufacturing changes. Assessment timeline: 60-day procedure (with possible clock stops for questions — total elapsed time typically 6-12 months). The applicant submits a variation application with supporting data (which may include new clinical trial results for indication extensions). CHMP issues an opinion, and the European Commission makes the formal decision. Type II variations are equivalent to US supplemental NDAs/BLAs in scope and significance. Type IA (minor, do-and-tell) and Type IB (minor, tell-wait-do) variations cover less significant changes. For peptide drugs, type II variations have been filed for: new indications (e.g. semaglutide weight management in addition to diabetes), formulation changes, and safety label updates.