Regulation (EC) No 1901/2006 of the European Parliament and of the CouncilShow full title

CHAPTER 2 Paediatric use marketing authorisation

Article 30

1. Submission of an application for a paediatric use marketing authorisation shall in no way preclude the right to apply for a marketing authorisation for other indications.

2. An application for a paediatric use marketing authorisation shall be accompanied by the particulars and documents necessary to establish quality, safety and efficacy in the paediatric population, including any specific data needed to support an appropriate strength, pharmaceutical form or route of administration for the product, in accordance with an agreed paediatric investigation plan.

The application shall also include the decision of the Agency agreeing the paediatric investigation plan concerned.

3. Where a medicinal product is or has been authorised in a Member State or in the Community, data contained in the dossier on that product may, where appropriate, be referred to, in accordance with Article 14(11) of Regulation (EC) No 726/2004 or Article 10 of Directive 2001/83/EC, in an application for a paediatric use marketing authorisation.

4. The medicinal product in respect of which a paediatric use marketing authorisation is granted may retain the name of any medicinal product which contains the same active substance and in respect of which the same holder has been granted authorisation for use in adults.

Article 31

Without prejudice to Article 3(2) of Regulation (EC) No 726/2004, an application for a paediatric use marketing authorisation may be made in accordance with the procedure laid down in Articles 5 to 15 of Regulation (EC) No 726/2004.