This document is an excerpt from the EUR-Lex website
The regulation aims to:
Pharmaceutical companies must work with the European Medicines Agency — set up under Regulation (EC) No 726/2004 (see summary) — to draw up and agree on paediatric investigation plans whose aim is to collect clinical data on the use of a medicine in children. The results of the paediatric investigation plan have to be submitted when applying for authorisation to market the medicinal products. In exchange, and as a reward, a company receives a 6-month extension of its supplementary protection certificate — a form of intellectual property right. For orphan medicines, a manufacturer has an extra 2 years of market exclusivity.
An independent paediatric committee inside the European Medicines Agency, advises on questions raised regarding children’s medicines and is responsible for the scientific assessment and approval of the paediatric investigation plans.
The regulation introduces:
Amendments to the regulation
Regulation (EU) 2019/5 amends Regulation (EC) No 1901/2006 in order to take into account that the specification of obligations that are subject to financial penalties are now laid down in Regulation (EC) No 726/2004 together with the powers that allow the Commission to lay down procedures for imposing such financial penalties.
Review and evaluation of the regulation
An evaluation of the paediatric regulation, along with the orphan drugs regulation, took place in 2019 and 2020. The evaluation involved several steps, including the publication of a roadmap, studies on paediatric medicines and on medicines for orphan diseases, and a wide consultation of interested parties. Following the results of this evaluation, an impact assessment for a revision of these two regulations has been launched.
The regulation has applied since 26 January 2007 with the exception of 4 of its articles:
For more information, see:
Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, pp. 1-19)
Successive amendments to Regulation (EC) No 1901/2006 have been incorporated into the original text. This consolidated version is of documentary value only.
Report from the Commission to the European Parliament and the Council: State of paediatric medicines in the EU — 10 years of the EU paediatric regulation (COM(2017) 626 final, 26.10.2017)
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, pp. 1-33)
See consolidated version.
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, pp. 67-128)
See consolidated version.
last update 16.09.2021