Do you remember when I posted an email response from MHRA that directed me to the "variations" dept. and everyone said I was lying, including YOU?
Current Status (as of January 2026)As of 15 January 2026, new EU-originated guidelines on the details of variation categories, procedures, and documentation apply in the UK (with exceptions for certain COVID-19 vaccine strain/sequence changes). Until then (and ongoing for classification), the MHRA continues to use the pre-2026 EU variations classification guideline to determine variation types (e.g., Type IA, IAIN, IB, II, or extension), conditions, and required supporting data.The core framework remains based on the embedded EU Variations Regulation (EC) No 1234/2008 (as amended) in UK law.Variation TypesType IA (including IAIN "do-and-tell immediate notification"): Minor changes with minimal/no impact (e.g., administrative). Implement first, notify MHRA within 12 months (or immediately for IAIN).
Type IB: Minor changes requiring approval before implementation (30-day assessment).
Type II: Major changes with potential significant impact (typically 30-90 day assessment; complex may be longer).
Extensions: Substantial changes treated as new applications.
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