The Paediatric Medicines Regulation 1901/2006 of the European Parliament and the European Council of 12 December 2006, requires that from 26 July 2008 applications for marketing authorisation include the results of an agreed paediatric investigation plan.

Article 7 (1) mandates the inclusion of an agreed paediatric investigation plan in applications for marketing authorisation under Article 6 of Directive 2001/83/EC in respect of a medicinal product for human use which is not authorised in the Community at the time of entry into force of this Regulation.

Article 9 specifies the exceptions where Article 7 does not apply, these are medicinal products authorised under Article 10 (generics), Article 10a (bibliographic applications), Articles 13 to 16 (homeopathic products) or 16a to 16i (traditional herbal products) of Directive 2001/83/EC.

According to Article 23, from 26 July 2008 the national licensing authorities or the European Medicines Agency (EMEA) are obliged to check if there is compliance between the investigation plan accepted by the Paediatric Committee (PDCO) and the submitted authorisation dossier, before accepting an application under Article 7 for processing.

The national authorities and the EMEA have the right to request the PDCO’s opinion on compliance, and they will make use of this right. The PDCO is obliged to give its opinion within 60 days.

For the planning of submissions of pharmaceutical applications that fall under Article 7 of the Paediatric Medicines Regulation, pay regard to the following stipulations:

1. processing times for PDCO and EMEA as set out in Articles 15 to 22;
2. possibility of a waiver for a paediatric investigation concept as set out in Articles 11 to 13;

3. updated European application form and updated requirements for Module 1, to be found at the European Commission’s website: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm