Medicines for children/Paediatric Worksharing

1. What impact had the Paediatric Regulation on the validation of new applications for marketing authorisation submitted as of 26 July 2008 and on variation applications submitted as of 26 January 2009?

In accordance with Article 7 of Regulation (EC) No. 1901/2006, a new application for marketing authorisation regarding a medicinal product for human use not yet authorised is considered valid only if it includes the results of paediatric studies as outlined in the paediatric investigation plan (PIP) or a decision of the European Medicines Agency (EMA) granting a product-specific waiver, class waiver, or deferral.

The provisions of Article 8 regarding extensions and variations entered into force on 26 January 2009.

2. Are there exceptions to Articles 7 and 8 of Regulation (EC) No. 1901/2006?

Yes, there are exceptions. Articles 7 and 8 do not apply to generics and medicinal products authorised through well-established medicinal use nor to homeopathic medicinal products and traditional herbal medicinal products.

3. Which paediatric studies had to be submitted by 26 January 2008 and which conditions had to be met?

In accordance with Article 45 of Regulation (EC) No. 1901/2006, all paediatric studies involving an authorised medicinal product had to be submitted, even if they had been concluded before the Regulation entered into force.

Article 46 refers only to studies sponsored by the marketing authorisation holder and not conducted in compliance with a paediatric investigation plan. Such studies have to be submitted to the competent authorities within six (6) months of completion of the study.

A paediatric study is any study performed in children below 18 years of age or in both children and adults.

4. Does this provision apply to all authorised medicinal products?

Yes, this provision applies to all authorised medicinal products, regardless of the authorisation procedure (purely national procedure, MRP/DCP, or centralised procedure) and the type of product (generics, homeopathic products, and officinal formulations).

5. Based on the studies submitted in accordance with Articles 45 and 46, can the approved indications be changed?

In accordance with Article 46, all studies involving the use of a medicinal product in children have to be submitted within six (6) months after completion of the respective studies. This deadline for submission even applies if the marketing authorisation holder (MAH) intends to submit a variation. In such cases, the MAH should indicate that he intends to submit a variation and whether and how this variation is related to the paediatric data being submitted. Also, the MAH should submit a proposal on how he intends to adapt the product information; ideally, the submission should be accompanied by an expert statement detailing the MAH’s intentions.

6. How are the results of Paediatric Work Sharing procedures in accordance with Articles 45 and 46 to be implemented?

After finalisation of the Paediatric Work Sharing procedure, the results are summarised in a paediatric assessment report (PAR) and published on the website of the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).

Should the Paediatric Work Sharing procedure results in changes to the summary of product characteristics and package leaflet, variations are to be submitted to the competent authority within the specified timelines after conclusion of the Paediatric Work Sharing procedure (see section "Guidance Documents" on CMD(h) website).

A Variation according to the Classification Guideline has to be submitted.

To access Regulation (EC) No. 1901/2006, click here.

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