Medicines for children

Paediatric worksharing - update of SmPC and PL

Paediatric Worksharing

The legal basis for the Paediatric Worksharing procedure are Article 45 and Article 46 of European Regulation (EC) No. 1901/2006 (“Paediatric Regulation”). 

Best Practice Guides regarding submission of paediatric studies are published on the website of the Heads of Medicines Agencies.

Aims of Paediatric Worksharing

The aim of Paediatric Worksharing is to provide healthcare professionals, patients, and parents with information about the use of medicinal products in the paediatric population (i.e., in individuals <18 years of age).

The European Medicines Agency (EMA) compiles a list of active substances to be assessed in accordance with Article 45, and the Co-ordination Group for Mutual Recognition and Decentralised Procedures—Human (CMDh) appoints a rapporteur. The rapporteur is responsible for overseeing the Paediatric Worksharing procedure, assessing the studies and publications submitted by the marketing authorisation holders (MAHs), and drawing up paediatric assessment reports (PARs) for all other member states. A consensus is then reached on the texts to be included in the summaries of product characteristics (SmPC) and package leaflets (PL) of the respective medicinal products. The MAHs of these products are obliged to implement the agreed texts into the SmPCs and PLs within 90 days after conclusion of the Paediatric Worksharing procedure by submitting a variation.

Updating the SmPC and PL

After finalisation of the Paediatric Worksharing procedure, the text recommendations to be included into the relevant SmPCs and PLs are published on the website of the Heads of Medicines Agencies.

The responsibility for implementing the text recommendations into the SmPCs and PLs of the medicinal products containing the active substance and available in the formulation in question lies with the MAH. To implement the changes, the MAH submits a variation with the competent authorities within 90 days after publication of the text recommendations.

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

Furthermore, MAHs are advised to take note of the provisions of AMG Article 3. Thus, it is prohibited to market medicinal products which, based on current scientific knowledge and practical experience may, in the normal conditions of use, be more harmful than what is acceptable in the light of current medical knowledge. Also, MAHs should regularly check the websites of the competent authorities for newly available information on implementing the required changes.

Effects of Paediatric Worksharing procedures on the relevant sections in SmPCs and PLs

The tables below provide an overview of which sections of the SmPC and PL may have to be updated as a result of a Paediatric Worksharing procedure:

  • Medicinal product has been already used in children
Result of the Worksharing procedureRecommendation for SmPC and PL
No new informationNo text changes
New information without effect on indication and/or dosageAdditional information about relevant studies in Section 5.1
New information with effect on indication and/or dosageChanges in Sections 4.1 and 4.2 and additional information in Section 5.1.
New safety-relevant information without effect on benefit-risk profileAdditional safety-relevant information in Sections 4.3 to 4.9
New safety-relevant information with effect on benefit-risk profileChanges regarding indication, dosage, and safety in Sections 4.1 to 4.9
  • Medicinal product has not yet been used in children
Result of the Worksharing procedureRecommendation for SmPC and PL
No data on safety and efficacyUse in children not recommended in Section 4.2, information about relevant studies in Section 5.1
No therapeutic benefit in children, safety-relevant informationUse in children not recommended in Section 4.2, information about relevant studies in Section 5.1, additional warnings and contraindications in Sections 4.3 and 4.4
New information about additional indications and new dosage recommendations for use in children

Changes regarding indication and safety in Sections 4.1 and 4.2 and additional information about relevant studies in Section 5.1

Recommended wording

Recommended wording for statements on the use of medicinal products in children to be included in SmPCs and PLs

The finalised paediatric assessment reports (PARs) are published on the website of the Heads of Medicines Agencies (HMA). The text recommendations contained in the PARs are to be translated into German and included in the relevant sections of the summary of product characteristics (SmPCs) and package leaflets (PLs) of the medicinal products concerned.

It is recommended that the German translations provided under the link given below be used. These translations have been made and published in consultation with the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM).

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