Paediatric

7.1 How and when should the agreed wording of the product information after a finalised Paediatric Worksharing procedure according to Regulation (EC) No 1901/2006 Article 45 and 46 be submitted?

In case the assessment leads to changes in the product information the submission of a type IB variation is expected. A type IB variation is only applicable if no new additional data are submitted by the Marketing Authorisation Holder (see section C.I.3 of Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products, 2010/C 17/01)

The application should include a confirmation that the texts as proposed in the variation are identical to those published in the Article 45/46 procedure and that no further changes are applied for. For further information, please refer to the Best Practice Guides on Article 45 and Article 46 published on the CMDh website under Paediatric Regulation > Guidance Documents. See the link:

 Guidance Documents  

Article 45
Marketing Authorisation Holders that have medicinal products included in the worksharing procedure are requested to submit a Type IB variation application within 60 days after finalisation of the procedure. For medicinal products not included in the worksharing procedure but with the same active substance and pharmaceutical form, the submission of a Type IB variation is expected to be submitted within 90 days of publication of the public assessment report. See the link:

 Assessment Reports on Paediatric Data

Article 46
The Marketing Authorisation Holder is requested to submit a type IB variation within 30 days after finalisation of the procedure. In case the assessment under Article 46 leads to changes in the product information that are considered necessary to guarantee safe use in the paediatric population of the medicinal products with the same active substance, submission of Type IB variation is expected from other Marketing Authorisation Holders within 60 days of publication of the public assessment report. See the link:

 Assessment Reports on Paediatric Data

Before starting a MRP including Repeat use agreed wording of product information after a finalised Paediatric Worksharing has to be implemented by the applicant.

 
 
 

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