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Qsauri
"C"

class waiver
Guideline or reference source
EMA Glossary of terms
Definition
An exemption from the obligation to submit a paediatric investigation plan for a class of medicines, such as medicines for diseases that only affect adults. Class waivers are adopted by the Paediatric Committee (PDCO).
Broader Term
waiver
Narrower Term
product-specific waiver
Related Term
paediatric committee
paediatric use marketing authorisation
product classification
 

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