Medicinal products for paediatric use

This law aims to ensure that medicines for children are fully adapted to their particular needs. It lays down specific obligations on the pharmaceutical industry, accompanying these with rewards and incentives.

ACT

Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on products for paediatric use and amending Regulation (EEC) No 1768/92, Directives 2001/20/EC and 2001/83/EC and Regulation (EC) No 726/2004 (see amending acts)

SUMMARY

This law aims to:

Companies must draw up paediatric investigation plans containing data on the use of a medicine in children when applying for authorisation to market their products. In exchange, and as an incentive, 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' market exclusivity.

An independent paediatric committee inside the European Medicines Agency advises on questions raised by children's medicines and is responsible for scientific assessment and approval of the paediatric investigation plans.

The law established:

In 2013, the Commission published a report which noted that, given the development cycle of medicines, it would require at least 10 years to gain full understanding of the law's impact. It pointed out that the requirement for companies to screen every new adult product for its potential paediatric use means that this factor is now an integral feature of a product’s overall development.

REFERENCES

Act

Entry into force - Date of expiry

Deadline for transposition in the Member States

Official Journal

Regulation (EC) No 1901/2006

26.1.2007

-

OJ L 378 of 27.12.2006

Amending act(s)

Entry into force

Deadline for transposition in the Member States

Official Journal

Regulation (EC) No 1902/2006

26.1.2007

-

OJ L 378 of 27.12.2006

RELATED ACTS

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 (Official Journal L136 of 30.4.2004)

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 (Official Journal L 311 of 28.11.2001)

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (Official Journal L 121 of 1.5.2001)

Report from the Commission to the European Parliament and the Council Better medicines for children - From concept to reality: General report on experience acquired as a result of the application of Regulation (EC) No 1901/2006 on medicinal products for paediatric use (COM(2013) 443 final of 24.6.2013 - not published in the Official Journal)

Last updated: 05.05.2014