PUMA - Pediatric Use Marketing Authorization
According to Article 30 of Regulation (EC) No 1901/2006 - The Paediatric Regulation, the paediatric use marketing authorisation (PUMA) is a dedicated marketing authorisation for medicinal products indicated exclusively for use in the paediatric population. It has been designed to promote paediatric development of already authorised products which are no longer covered by a supplementary protection certificate (SPC) or a patent qualifying for a SPC.
Incentives:
- 8+2 year period of data and market protection
- Partial exemption from the payment of fees
- ‘Automatic access’ to the centralised procedure
- A medicinal product for which a PUMA has been granted may retain the name of another medicinal product containing the same active substance for which the same holder has been granted an authorisation for use in adults
Required Documentation:
- Combination of new data and/or existing data
- Depending on the legal basis of the application, submission of literature and/or cross-reference to the dossier of another medicinal product may be used.
- A PUMA application has to contain the results of all studies performed and details of all information collected in compliance with an agreed Paediatric Investigation Plan (PIP).
- PDCO opinion on compliance or the applicant’s compliance report must be provided in Module 1.10
- Risk management plan
Reference:
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