1. Where an application under Article 7 or 8 includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, the holder of the patent or supplementary protection certificate shall be entitled to a six-month extension of the period referred to in Articles 13(1) and 13(2) of Regulation (EEC) No 1768/92.
The first subparagraph shall 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.
2. The inclusion in a marketing authorisation of the statement referred to in Article 28(3) shall be used for the purposes of applying paragraph 1 of this Article.
3. Where the procedures laid down in Directive 2001/83/EC have been used, the six-month extension of the period referred to in paragraph 1 shall be granted only if the product is authorised in all Member States.
4. Paragraphs 1, 2 and 3 shall apply to products that are protected by a supplementary protection certificate under Regulation (EEC) No 1768/92, or under a patent which qualifies for the granting of the supplementary protection certificate. They shall not apply to medicinal products designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000.
5. In the case of an application under Article 8 which leads to the authorisation of a new paediatric indication, paragraphs 1, 2 and 3 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, in accordance with Article 14(11) of Regulation (EC) No 726/2004 or the fourth subparagraph of Article 10(1) of Directive 2001/83/EC.
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 and that application includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, and the statement referred to in Article 28(3) of this Regulation is subsequently included in the marketing authorisation granted, the ten-year period referred to in Article 8(1) of Regulation (EC) No 141/2000 shall be extended to twelve years.
The first paragraph shall 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.
1. Where a paediatric use marketing authorisation is granted in accordance with Articles 5 to 15 of Regulation (EC) No 726/2004, the data and marketing protection periods referred to in Article 14(11) of that Regulation shall apply.
2. Where a paediatric use marketing authorisation is granted in accordance with the procedures laid down in Directive 2001/83/EC, the data and marketing protection periods referred to in Article 10(1) of that Directive shall apply.
1. In addition to the rewards and incentives provided for in Articles 36, 37 and 38, 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.
2. By 26 January 2008, 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.
3. By 26 July 2008, the Commission shall make publicly available a detailed inventory of all rewards and incentives provided by the Community and Member States to support research into, and the development and availability of, medicinal products for paediatric use. This inventory shall be updated regularly and the updates shall also be made publicly available.
1. Funds for research into medicinal products for the paediatric population shall be provided for in the Community budget in order to support studies relating to medicinal products or active substances not covered by a patent or a supplementary protection certificate.
2. The Community funding referred to in paragraph 1 shall be delivered through the Community Framework Programmes for Research, Technological Development and Demonstration Activities or any other Community initiatives for the funding of research.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
