Type II variation: major change requiring prior approval
A Type II variation is a major change that may significantly affect a medicine's quality, safety or efficacy and needs approval before implementation.
Typical Type II changes include a new therapeutic indication, significant safety updates to the SmPC based on new data, and substantial manufacturing changes. They are assessed by EMA's committees for centrally authorised products, by the RMS for MRP and DCP products, and by the national authority for purely national ones.
Problems arise when a change is split to avoid Type II, when the supporting data does not address the requested change, and when grouped or worksharing submissions are scoped badly. A new indication may also need an updated risk management plan and environmental risk assessment.
Timing
The standard Type II evaluation takes 60 days, which can be shortened to 30 days for urgent safety issues or extended to 90 days for new indications and some grouped changes. Requests for supplementary information stop the clock. Centrally authorised products then need a Commission decision; for other products, Member States update the authorisation within set deadlines, two months for changes such as a new indication.
Used in
For budgeting, calculate the authority fees for a Type II variation per market and procedure with the Regunaut fee calculator.
Related terms
- Type IB variation: minor change notified before implementationA Type IB variation is a minor change that is neither Type IA nor Type II and must be notified to the authority before it is implemented.
- PACMP: post-approval change management protocolA post-approval change management protocol (PACMP) pre-agrees the data for a future CMC change so the change can later be filed in a lower category.
- Worksharing: one assessment of a variation across several authorisationsWorksharing lets one authority assess the same Type IB or Type II variation for several marketing authorisations of the same holder in a single procedure.
- Grouping of variations: several changes in one submissionGrouping of variations is the filing of several changes to one or more marketing authorisations in one submission under Article 7 of Regulation 1234/2008.
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