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Qdossier Qsauri
"T"

type-1a variation
Guideline or reference source
EMA Glossary of terms
Definition
A minor change to a marketing authorisation that has a minimal or no impact on the quality, safety or efficacy of the medicine and does not require prior approval before implementation by the marketing-authorisation holder.
Broader Term
variation
Related Term
type-1b variation
type-2 variation
 

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