Paediatric Worksharing

Paediatric Worksharing

The legal basis for the Paediatric Work Sharing procedure is Article 45 of European Regulation (EC) No. 1901/2006 (“Paediatric Regulation”).

Aims of Paediatric Work Sharing

The aim of Paediatric Work Sharing is to provide healthcare professionals, patients, and parent 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 Work Sharing 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 Work Sharing procedure by submitting a variation.

Updating the SmPC and PL

After conclusion of the Paediatric Work Sharing 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.

Procedure: 
 

1. If the text recommended in the PAR and published on the website of the Heads of Medicines Agencies is implemented into the SmPCs and PLs exactly as is, the MAH merely has to confirm the textual change using the Supplementary Form for National Variations Regarding the Use of Authorised Medicinal Products in Children in Accordance with Articles 45 and 46 of Regulation (EC) No. 1901/2006. For variations in accordance with Article 24 (6) of the Austrian Medicines Act (Arzneimittelgesetz, AMG), no additional documentation is required, and no additional assessments or changes will be made.
2. Any additional changes the MAH intends to implement as a result of the Paediatric Work Sharing procedure are to be submitted as variations in accordance with AMG Article 24 (4).
3. If the text recommended in the PAR and published on the website of the Heads of Medicines Agencies is not implemented into the SmPCs and PLs exactly as is, a variation in accordance with AMG Article 24 (2) 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 regulalry check the websites of the competent authorities for newly available information on implementing the required changes.

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

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

Medicinal product has already been used in children

Medicinal product has not yet been used in children