Paediatric medicines

Marketing authorisations

The Regulation of Paediatric Medicines (EC 1901/2006 and EC 1902/2006) entered into force on 26 January 2007. Its Article 7 applies to all new medicines attempting to reach the EU markets that do not have a previous marketing authorisation in Europe. Such medicines must have an agreed Paediatric Investigation Plan (PIP). This requirement applies to marketing authorisation applications submitted to the centralised, decentralised, mutual recognition and national procedure process.

Pursuant to Article 8, the Regulation also applies to those medicines already on the market that are still protected by a patent or a supplementary protection certificate (see variation application below).

The requirements in the Regulation of Paediatric Medicines do not apply to application types 10(1), 10(3), 10(4) and 10(a) in Directive 2001/83/EC.

The marketing authorisation application must be accompanied with the EMA Decision, information about the agreed PIP or a Product Specific Waiver or Class Waiver. The documentation is mandatory in order to have the application validated.

Paediatric Investigation Plan

The PIP is agreed with the Paediatric Committee (PDCO) of the European Medicines Agency (EMA). The PIP must be agreed upon early in the development. For more information on the procedure for agreeing upon the PIP, please see the EMA website.

Variation applications

Pursuant to Article 8, the Regulation of Paediatric Medicines also applies to Type II variation applications, in which the variation concerns the extension of the therapeutic indication (a new therapeutic indication or age group), a new pharmaceutical form or a new route of administration.

Compliance check

Depending on the scheduling of the research programme, the PIP must also be subjected to a compliance check, either by PDCO (centralised procedure) or RMS (national procedure). Documentation on the compliance check must be submitted along with the application material, or its review must be agreed upon with the RMS.