Paediatric use

Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use

Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use came into force on 26 January 2007. The purpose of this regulation is to facilitate the development and accessibility of medicinal products for the paediatric population, improve the available information on the use of these medicinal products and ensure that medicines used in the treatment of the paediatric population are subject to high quality and ethical research. Based on the Regulation on medicinal products for paediatric use, a Committee for Medicinal Products for Paediatric Use was established at EMA.

Obligations of applicants or marketing authorisation holders in respect of the following articles of the Regulation on medicinal products for paediatric use:

Article 45 of the Regulation on medicinal products for paediatric use

In accordance with Article 45 of the Regulation on medicinal products for paediatric use, marketing authorisation holders have submitted to EU authorities competent for medicinal products, and thus also to JAZMP, a list of paediatric studies that had been conducted up to 28 January 2008 for medicinal products authorised in the EU. The aim of Article 45 is to update information regarding paediatric use of medicinal products in the summary of product characteristics and in the package leaflet, based on the submitted studies. Currently, ongoing evaluation of these studies is based on the division of work between Member States. The data or studies that will be evaluated with respect to paediatric use in the process of work division will be submitted to JAZMP in electronic form by marketing authorisation holders. On completion of the process of division of work between Member States, changes in the text of SPC and PIL relating to use with children will be published on the website of the CMDh Group. Marketing authorisation holders that participated in the work division process in accordance with Article 45 must, within 60 days from the conclusion of the process, submit type IB variation to JAZMP. All other holders of marketing authorisations for medicinal products with the same active ingredient and pharmaceutical form must submit to JAZMP type IB variation for change of SPC and PIL within 90 days of publication of the evaluation report for a given substance on the CMDh website. Detailed guidelines relating to Article 45 are available on the HMA website:http://www.hma.eu/213.html.

Article 46 of the Regulation on medicinal products for paediatric use

In accordance with Article 46 of the Regulation on medicinal products for paediatric use, all paediatric studies completed after 26 January 2007 must be submitted by marketing authorisation holders to the bodies competent for medicinal products, including JAZMP, within 6 months of completion of the study. Ongoing evaluation of these studies is based on the division of work between Member States. Marketing authorisation holders that participated in the work division process in accordance with Article 46 must, within 30 days of the conclusion of the process, submit type IB variation to JAZMP. All other holders of marketing authorisations for medicinal products with the same active ingredient and pharmaceutical form must submit to JAZMP type IB variation for change of SPC and PIL within 60 days of publication of the evaluation report for a given substance on the website of the CMDh Group. Detailed guidelines relating to Article 46 are available on the HMA website:  http://www.hma.eu/216.html.

Contact e-mail relating to Articles 45 and 46:  paediatric@jazmp.si.

Article 29 of the Regulation on medicinal products for paediatric use

In the case of applications dealt with in accordance with Article 29 of the Regulation on medicinal products for paediatric use, the applicant or marketing authorisation holder must submit an application for variation which requires a new application (in the case of a new pharmaceutical form or route of administration) or type IB variation, classification C.I.1 z (in the case of additional indications), IMMEDIATELY after publication of the decision of the European Commission. JAZMP will issue a new marketing authorisation or amend the one already issued accordingly within 30 days of the decision of the European Commission. More detailed instructions regarding the procedure and the documentation submitted can be found in the CMDh document  “Recommendations for implementing Commission Decisions following Article 29 Application under the Paediatric Regulation” on the website: http://www.hma.eu/216.html.