Submitting paediatric studies

The Paediatric Regulation requires marketing-authorisation holders to submit the results of studies conducted in children to the ‘competent authorities’: the European Medicines Agency and regulatory authorities in European Union (EU) Member States. This requirement is found in Articles 45 and 46 of the Regulation.

• Questions and answers on the Paediatric Regulation (Regulation of the European Parliament and of the Council (EC) no 1901/2006, as amended)

Article 45

Article 45 requires marketing authorisation holders to submit information on all paediatric studies completed by the date of entry into force of the Paediatric Regulation on 26 January 2007. These studies had to be submitted by 26 January 2008.

A public database of these studies is available:

• Article 45 paediatric studies database
• Publication of results-related information on paediatric studies submitted under Article 45 of the Regulation (EC) No 1901/2006 (‘Paediatric Regulation’)

Article 46

Article 46 requires marketing-authorisation holders to submit information on studies of authorised medicines used in the paediatric population that were ongoing when the Paediatric Regulation came into force on 26 January 2007 and are sponsored by the marketing-authorisation holder. Information must be submitted within six months of completion of each study.

• Q&A: Article 46 paediatric study submission
• European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

There are two e-mail addresses for submissions according to Article 46:

• Centrally authorised medicines: paedstudies46-cap@ema.europa.eu
• Nationally authorised medicines: paedstudies46-nat@ema.europa.eu

Please make sure you send your submissions to the correct address.

Submission of information on the use of medicines in children

Marketing-authorisation holders of centrally authorised medicines are reminded of the obligation set out in Article 16(2) of Regulation (EC) No 726/2004 to submit any information available on the use of the medicinal product in children.

For information on submission, see:

• Q&A: Type II variations
• Q&A: Follow-up measures / specific obligations