Rewards and incentives
Rewards and incentives
The holder of a patent or supplementary protection certificate is entitled to a six-month extension of the period of protection provided that the application is accompanied by the results of all the studies conducted in compliance with an agreed paediatric investigation plan in respect of the paediatric medicine already authorised. This provision will also apply where completion of the agreed paediatric investigation plan fails to lead to the authorisation of a paediatric indication, but the results of the studies conducted are reflected in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product concerned.
Where the procedures laid down in Directive 2001/83/EC have been used, the six-month extension of the period is granted only if the product is authorised in all Member States.
The foregoing paragraphs shall not apply if the applicant applies for, and obtains, a one-year extension of the period of marketing protection for the medicinal product concerned, on the grounds that this new paediatric indication brings a significant clinical benefit in comparison with existing therapies.
Where an application for a marketing authorisation is submitted in respect of a medicinal product designated as an orphan medicinal product pursuant to Regulation (EC) No 141/2000, the ten-year period referred to in Article 8(1) of Regulation (EC) No 141/2000 shall be extended to twelve years. The application must be accompanied by the results of all the studies conducted in compliance with the agreed paediatric investigation plan included in the summary of product characteristics. If a paediatric use marketing authorisation is granted for a medicinal product under Regulation (EC) No 726/2004, the periods for protection of data and marketing provided for in the Regulation will apply.
Additionally, medicinal products for paediatric use may be eligible for incentives provided by the Community or by the Member States to support research into, and the development and availability of, medicinal products for paediatric use.
The Member States shall communicate to the Commission detailed information concerning any measures they have enacted to support research into, and the development and availability of, medicinal products for paediatric use This information shall be updated regularly at the request of the Commission.