type-2 variation
- Guideline or reference source
- EMA Glossary of terms
- Definition
- A major change to a marketing authorisation that may have a significant impact on the quality, safety or efficacy of a medicine, but does not involve a change to the active substance, its strength or the route of administration. Type-II variations require a formal approval.
- Broader Term
- variation
- Related Term
- type-1a variation
- type-1b variation
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