European Medicines Agency - Human Medicines - Referrals - Article 29 paediatric referrals

Human Medicines - Referrals
List of Referrals - Article 29 - 'paediatric referrals'
Background
Article 29 of Regulation (EC) No 1901/2006 begin_of_the_skype_highlighting 1901/2006 end_of_the_skype_highlighting as amended foresees that an application as referred to in article 8 of the said regulation can be submitted, in accordance with the procedure laid down in articles 32, 33 and 34 of Directive 2001/83/EC, for products authorised under Directive 2001/83/EC.

In this referral procedure, the marketing authorisation holders may apply for a new indication, a new pharmaceutical form or a new route of administration.

The application shall comply with the requirements laid down in point (a) of article 7(1) of Regulation (EC) No 1901/2006 begin_of_the_skype_highlighting 1901/2006 end_of_the_skype_highlighting, regarding the inclusion of the results of all studies performed and details of all information collected in compliance with an agreed paediatric investigation plan.

At the end of the referral, the CHMP opinion may contain a recommendation for some changes to the prescribing information (such as the Summary of Product Characteristics wording), for the approval of a new pharmaceutical form and/or a new route of administration. It can also contain some conditions to the marketing authorisation, to ensure the safe and effective use of the medicine in the paediatric population. The assessment is limited to the specific sections of the product information to be varied.

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European Medicines Agency - Human Medicines - Referrals - Article 29 paediatric referrals