Guidance

Guidance

on the submission of national variations regarding authorised medicinal products for use in children in accordance with Articles 45 and 46 of Regulation (EC) No. 1901/2006

The European Regulation (EC) No. 1901/2006 (“Paediatric Regulation”) on medicinal products for paediatric use entered into force with immediate effect in all member states on 26 January 2007. It aims at making high-quality, safe, and effective medicinal products available for use in children. To this end, the Regulation specifies the development and authorisation requirements for new products yet to be authorised. At the same time, the Regulation requires any paediatric studies involving the use of medicinal products already authorised to be submitted to the competent authority for assessment (cf. Articles 45 and 46 of the Regulation).

This allows the competent authority to:

1. assess the safety and efficacy of the medicinal product and to prevent children from receiving inadequate treatment, e.g., because of over- or under-dosage, unsuitable formulations, or insufficiently tested dosage recommendations  
2. prevent clinical studies in children in cases where the available database is sufficient to allow adequate treatment recommendations to be made 
3. update the summary of product characteristics (SmPC) and package leaflet (PL) in accordance with the data submitted (e.g., in terms of available dosages or formulations)

Legal background—European legislation in brief
Submission of paediatric studies involving the use of authorised medicinal products in accordance with Articles 45 and 46 of Regulation (EC) No. 1901/2006 (“Paediatric Regulation”):

Paediatric studies involving the use of an authorised medicinal product which were completed by the date of entry into force of the Regulation were submitted to the competent authority by the marketing authorisation holder (MAH) by 26 January 2008.

Other studies sponsored by the MAH that involve the use of an authorised medicinal product in children are to be submitted to the competent authority within six (6) months of completion of the respective studies, regardless of whether these studies were performed in compliance with an agreed paediatric investigation plan (PIP).

1. The competent authorities exchange information regarding the studies submitted and the implications the study results may have on any marketing authorisation concerned.  
2. This exchange of information is coordinated by the Co-ordination Group for Mutual Recognition and Decentralised Procedures—Human (CMDh) of the European Medicines Agency (EMA).  
3. The competent authority shall update the SmPC and PL accordingly and vary the respective marketing authorisation.
   The procedure for the submission of paediatric study results has been harmonised between the EU member states and the EMA and is summarised in the “Guidance on the Submission of Data on Medicinal Products for Use in Children in Accordance with Regulation (EC) No. 1901/2006”.