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MHRA: EU Paediatric Regulation: Revised guidance on undertaking the compliance check

25.03.2009
MHRA:
EU Paediatric Regulation: Revised guidance on undertaking the compliance check. Marketing Authorisation holders are reminded that the obligation for applications for new indications (including paediatric indications), new pharmaceutical forms and new routes of administration to comply with a Paediatric Investigation Plan (PIP) came into force on 26 January 2009. This requirement arises from Article 8 of the EU Paediatric Regulation.

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