exceptional circumstances
- Guideline or reference source
- EMA Glossary of terms
- Definition
- A type of marketing authorisation granted to medicines where the applicant is unable to provide comprehensive data on the efficacy and safety under normal conditions of use, because the condition to be treated is rare or because collection of full information is not possible or is unethical.
- Used For
- marketing authorisation under exceptional circumstances
- Broader Term
- marketing authorization application
- Related Term
- marketing authorization
- specific obligation
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