Regulation (EC) No 1901/2006 Paediatric Use - Guidance Document
12 October 2007
Regulation (EC) No 1901/2006 as amended governing the development and authorisation of medicines for use in children aged between 0 and 18 years came into effect in the European Union on the 26th of January 2007.
This legislation introduces sweeping changes into the regulatory environment for paediatric medicines, the overall aim of which is to improve the health of children in the European Union. It is hoped that this will be achieved by improving the information available on the use of medicines in the various paediatric populations by encouraging high quality ethical research, development and appropriate authorisation of medicines for use in children, ultimately increasing the amount of robust information existing about the use of medicines in children and increasing the availability of medicines in this population throughout the EU. Part of the aim of this legislation is to achieve these objectives without subjecting the paediatric population to unnecessary clinical trials and without delaying the authorisation of medicinal products in the adult population.
One of the main provisions of the regulation, effective immediately, is the submission of paediatric studies (as per Articles 45-46). Market Authorisation Holders must submit to the IMB all paediatric studies already completed by date of entry into force of the regulation in respect of products already authorised in the IMB. The latest date for submission of these studies is the 26th of January 2008. In addition, any other MAH-sponsored studies where an already IMB authorised product has been used in the paediatric population must be submitted to the IMB within 6 months of completion. This applies independent of whether or not the MAH intends to apply for a marketing authorisation of a paediatric indication. Following assessment of this data, the IMB may update the Summary of Product Characteristics and Patient Information Leaflet and vary the marketing authorisation accordingly.
Please refer to the guidance and templates available on the CMD(h) website at http://www.hma.eu/216.html
All information required as per the CMD(h) guidance, relating to products authorised nationally (including MRP and DCP) should be submitted in the required templates and sent in electronic format only to HM_Paediatric@imb.ie
In addition, for nationally authorised medicinal products, MAHs need to send a copy of all templates to the EMEA to the following e-mail address email@example.com
Further information relating to the new paediatric regulation is available on the EMEA website at http://www.emea.europa.eu/htms/human/paediatrics/introduction.htm
Questions relating specifically to the authorisation of paediatric medicines may be submitted to firstname.lastname@example.org and any IMB related queries can be sent to email@example.com