Paediatric Regulation: Responsibilities of Marketing Authorisation Holders
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 28 January 2008 (Article 45).
Other studies with an authorised medicinal product 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 (Article 46).
Information on paediatric use of all authorised medicinal products has to be collected to identify medicinal products eligible for the paediatric symbol when it has been agreed (Article 32) and to satisfy the requirement for Member States to collect available data on all existing paediatric use and to communicate the data to the EMEA by 26 January 2009 (Article 42).
A guidance document has been published on CMD(h) website in order to facilitate the submission of information on medicinal products as requested by the Paediatric Regulation. The procedural guidance and the standard templates are available: http://www.hma.eu/213.html
The completed templates have to be sent to State Agency of Medicines: paediatric@ravimiamet.ee
and copied to the EMEA: paedstudies@emea.europa.eu
If additional information is required, please contact: paediatric@ravimiamet.ee
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