Marketing authorisation holders must be aware that an agreement has been entered into between CMD(h) and EMA regarding reporting of paediatric data for already approved medicinal products via national, MRP or DCP procedures (cf. articles 45 and 46 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006, as amended).
The agreement appears from the press release issued by the CMD(h) meeting held on 17, 18 and 19 September 2007.
The guidelines, template, etc. are available under Paediatric Regulation, CMD(h) at the Heads of Medicines Agencies website.
Please report paediatric data electronically to the Danish Medicines Agency's email address firstname.lastname@example.org.