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Regulation (EC) No 1901/2006 of the European Parliament and of the CouncilShow full title
Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance)
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- Regulation revoked in part by S.I. 2019/775 Sch. 9 para. 1(l)
TITLE I INTRODUCTORY PROVISIONS
TITLE II MARKETING AUTHORISATION REQUIREMENTS
CHAPTER 1 General authorisation requirements
Article 7.(1) An application for marketing authorisation under Article 6 of Directive...
Article 8.In the case of authorised medicinal products which are protected...
Article 9.Articles 7 and 8 shall not apply to products authorised...
Article 10.In consultation with the Member States, the Agency and other...
CHAPTER 3 Paediatric investigation plan
Section 1 Requests for agreement
Article 15.(1) Where the intention is to apply for a marketing...
Article 16.(1) In the case of the applications for marketing authorisation...
Article 17.(1) Following receipt of a proposed paediatric investigation plan which...
Article 18.As soon as the Paediatric Committee adopts an opinion, whether...
Article 19.If, having considered a paediatric investigation plan, the Paediatric Committee...
TITLE V REWARDS AND INCENTIVES
Article 36.(1) Where an application under Article 7 or 8 includes...
Article 37.Where an application for a marketing authorisation is submitted in...
Article 38.(1) Where a paediatric use marketing authorisation is granted in...
Article 39.(1) In addition to the rewards and incentives provided for...
Article 40.(1) Funds for research into medicinal products for the paediatric...
TITLE VI COMMUNICATION AND COORDINATION
Article 41.(1) The European database created by Article 11 of Directive 2001/20/EC...
Article 42.Member States shall collect available data on all existing uses...
Article 43.(1) On the basis of the information referred to in...
Article 44.(1) The Agency shall, with the scientific support of the...
Article 45.(1) By 26 January 2008, any paediatric studies already completed,...
Article 46.(1) Any other marketing authorisation holder-sponsored studies which involve the...
TITLE VII GENERAL AND FINAL PROVISIONS
Article 52.Regulation (EEC) No 1768/92 is hereby amended as follows: in Article 1,...
Article 53.In Article 11 of Directive 2001/20/EC, the following paragraph shall be...
Article 54.In Article 6 of Directive 2001/83/EC, the first subparagraph of paragraph...
Article 55.Regulation (EC) No 726/2004 is hereby amended as follows: Article 56(1) shall...
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