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Regulation (EC) No 1901/2006 Article 47

Regulation (EC) No 1901/2006 Article 47

Article 47

1.   Where an application for a paediatric use marketing authorisation is submitted in accordance with the procedure laid down in Regulation (EC) No 726/2004, the amount of the reduced fees for the examination of the application and the maintenance of the marketing authorisation shall be fixed in accordance with Article 70 of Regulation (EC) No 726/2004. 2.   Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Medicines Agency  ( 9 ) shall apply. 3.   Assessments of the following by the Paediatric Committee shall be free of charge: (a) applications for waiver; (b) applications for deferral; (c) paediatric investigation plans; (d) compliance with the agreed paediatric investigation plan.

Read the full instrument → · Read this in context: Section 1 — Fees, community funding, penalties and reports →

Other provisions in Section 1 — Fees, community funding, penalties and reports

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 47 of Regulation (EC) No 1901/2006 (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

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