product-specific waiver
- Guideline or reference source
- EMA Glossary of terms
- Definition
- An exemption from the obligation to acquire data, through a paediatric investigation plan, in some or all subsets of the paediatric population for a given condition, route of administration and pharmaceutical form of a specified medicine. Product-specific waivers are adopted by the Paediatric Committee (PDCO).
- Broader Term
- class waiver
- waiver
- Related Term
- paediatric committee
- paediatric investigation plan
- paediatric use marketing authorisation
- product classification
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