European Medicines Agency - Human Medicines - Medicines for children - Submission of paediatric studies

Medicines for children
Guidance for applicants
Submission of paediatric studies (Articles 45-46)
In accordance with Article 45, the Paediatric Regulation requires marketing authorisation holders to submit to the competent authorities all paediatric studies completed by the date of entry into force of the legislation (26 January 2007). These studies must be submitted by 26 January 2008.
In accordance with Article 46, studies with an authorised medicine used in the paediatric population, if sponsored by the marketing authorisation holder, have to be submitted to the competent authorities within six months of their completion.

What if my product is a Centrally Authorised Product (CAP)?

Art 45

http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Guidance_Documents/Q_As_Paed_Reg_Rev5-Clean.pdf

Art 46

http://www.emea.europa.eu/htms/human/postguidance/list.htm

http://www.emea.europa.eu/htms/human/postguidance/31000706en.pdf

In addition, Marketing authorisation holders for products authorised through the Community procedure are also 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 submission of paediatric studies for centrally authorised products, please apply the same submission requirements as for type II variation / Follow-up Measures which can be found here.

What if my product is a non-Centrally Authorised Product (non-CAP)?

Joint EMEA/CMD(h) best-practice guide on submission of paediatric studies
Where do I send my submission?

There are two EMEA mailboxes for submissions according to Article 45, one dedicated to CAPs and the other to national products: paedstudies45-cap@emea.europa.eu and paedstudies45-nat@emea.europa.eu, respectively. Please ensure your submissions are posted to the dedicated mailbox only.

There are two EMEA mailboxes for submissions according to Article 46, one dedicated to CAPs and the other to national products: paedstudies46-cap@emea.europa.eu and paedstudies46-nat@emea.europa.eu, respectively. Please ensure your submissions are posted to the dedicated mailbox only.

abrir aquí para acceder al documento EMEA paediatrics completo:
European Medicines Agency - Human Medicines - Medicines for children - Submission of paediatric studies