Marketing-authorisation holders (MAHs) are obliged to place their medicines on the market following completion of an agreed paediatric investigation plan within two years of obtaining a paediatric indication.
This obligation derives from Article 33 of the Paediatric Regulation.
For additional procedural advice on Articles 33 and 35 of the Paediatric Regulation on marketing a medicine authorised for a paediatric indication, see the relevant section on Paediatric investigation plans: questions and answers.
The document below includes information on the fulfilment of this requirement. This information is either provided voluntarily by MAHs or following requests by the Agency after expiration of the deadline.
The Agency updates this document at least once a year.
|Document(s)||Language||Status||First published||Last updated||Effective Date|
|Register of deadlines to put a medicinal product on the market in accordance with Article 33 of the Paediatric Regulation||(English only)||2013-03-05||2017-02-16|