unforseen variation
- Guideline or reference source
- CMDh/EMA/133/2010/Rev6 EMA/CMDh EXPLANATORY NOTES ON VARIATION APPLICATION FORM
- Definition
- A variation is considered ‘unforeseen’ when the proposed variation is not considered a minor variation of Type IB following the Commission Guideline, or has not been classified as a Type IB variation in an Article 5 recommendation.
- Broader Term
- variation
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