2004/0599(COD)

Paediatric Medicinal Products Regulation

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/83/EC and Regulation (EC) No 726/2004

Stage: In force, reached 27 Dec 2006
In force: In force since 26 Jan 2007 · CELEX 32006R1901
Procedure: Regulation · Ordinary legislative procedure
Last activity: 26 Jan 2007

1 act

Delegated and implementing acts beneath it

By status: 1 published.

Act	Kind	Status	Adoption
Appointing members and alternates of the Paediatric Committee to represent health professionals and patient associations	Commission · Decision	Published

Titles link to EUR-Lex where the act has been published.

Summary

Generated

Regulation (EC) No 1901/2006 requires paediatric investigation plans for new medicines and those under patent, with waivers and deferrals, and rewards compliance with a six-month supplementary protection certificate extension. Orphan products get 12 years' market exclusivity instead of 10.

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Sources: EP Legislative Observatory · EU Law Tracker · EUR-Lex. Record as of 12 Oct 2026. Something wrong on this page? Report an error.

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