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Paediatric Worksharing according to Article 45 and 46 Regulation (EG) No. 1901/2006

Variations based on the assessment of paediatric clinical trials with authorised medicinal products

Any paediatric studies already completed, by the date of entry into force of Regulation (EC) No. 1901/2006, in respect of products authorised in the Community shall be submitted by the marketing authorisation holder for assessment to the competent authority. The competent authority may update the Summary of Product Characteristics and Package Leaflet, and may vary the marketing authorisation accordingly.

The Member States agreed on a ‚Paediatric Worksharing Project’ to avoid double assessments. Members States are acting as Rapporteur for the assessment of clinical trials for medicinal products with the same active substance. Marketing Authorisation Holders, which have submitted clinical trials, are involved in the assessment.

The European Medicinal Agency (EMEA) coordinates this project. Information on the Paediatric Worksharing Project is to be found on the website of the Heads of Medicines Agencies (HMA) http://www.hma.eu/99.html ((Paediatric Regulation, Worksharing on Article 45).

The final assessment with the recommendation for update of the Summary of Product Characteristics and the Package Leaflet in the follow-up the variation, if necessary, are provided on website http://www.hma.eu/269.html (Article 45 work-sharing Assessment Reports).

According to Article 46 of the Regulation (EC) No. 1910/2006 studies have to be submitted to the competent national authority and will be also assessed in the ‚Paediatric Worksharing Project’.

The variation procedure to up date the Summary of Product Characteristics and the Package Leaflet according to the assessment of the ‘Paediatric Worksharing Procedure’ has to follow the Marketing Authorisation Procedure. For Marketing Authorisations based on a Mutual Recognition Procedure or Decentralised Procedure the variations have to be handled by the Reference Member State according to Regulation (EC) No. 1084/2003/EC.

For all Marketing Authorisation for medicinal products granted nationally a national variation has to be submitted to the competent authority of the Member State, for Germany according to § 29 German Drug Law (Arzneimittelgesetz).

The BfArM has implemented a specific procedure for these variations (national, MRP and DCP).
For variations submitted to update the Summary of Product Characteristics and Package Leaflet according to Article 45 and 46 this form and the standard form for the variation procedure has to be used independently by submitting the variation with or without using the Online-Portal http://www.pharmnet-bund.de/dynamic/en/elektr-aend-anz/index.html.

For follow-up questions please contact:

Paediatric Worksharing: Dr. Birka Lehmann, Gabriele Eibenstein.
Variation procedure: Susanne Winterscheid, Dr. Günter Omlor.