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Regulation (EC) No 1901/2006 of the European Parliament and of the CouncilDangos y teitl llawn

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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  1. Introductory Text

  2. TITLE I INTRODUCTORY PROVISIONS

    1. CHAPTER 1 Subject matter and definitions

      1. Article 1.This Regulation lays down rules concerning the development of medicinal...

      2. Article 2.In addition to the definitions laid down in Article 1 of...

    2. CHAPTER 2 Paediatric committee

      1. Article 3.(1) By 26 July 2007, a Paediatric Committee shall be...

      2. Article 4.(1) The Paediatric Committee shall be composed of the following...

      3. Article 5.(1) When preparing its opinions, the Paediatric Committee shall use...

      4. Article 6.(1) The tasks of the Paediatric Committee shall include the...

  3. TITLE II MARKETING AUTHORISATION REQUIREMENTS

    1. CHAPTER 1 General authorisation requirements

      1. Article 7.(1) An application for marketing authorisation under Article 6 of Directive...

      2. Article 8.In the case of authorised medicinal products which are protected...

      3. Article 9.Articles 7 and 8 shall not apply to products authorised...

      4. Article 10.In consultation with the Member States, the Agency and other...

    2. CHAPTER 2 Waivers

      1. Article 11.(1) Production of the information referred to in point (a)...

      2. Article 12.The Paediatric Committee may of its own motion adopt an...

      3. Article 13.(1) The applicant may, on the grounds set out in...

      4. Article 14.(1) The Agency shall maintain a list of all waivers....

    3. CHAPTER 3 Paediatric investigation plan

      1. Section 1 Requests for agreement

        1. Article 15.(1) Where the intention is to apply for a marketing...

        2. Article 16.(1) In the case of the applications for marketing authorisation...

        3. Article 17.(1) Following receipt of a proposed paediatric investigation plan which...

        4. Article 18.As soon as the Paediatric Committee adopts an opinion, whether...

        5. Article 19.If, having considered a paediatric investigation plan, the Paediatric Committee...

      2. Section 2 Deferrals

        1. Article 20.(1) At the same time as the paediatric investigation plan...

        2. Article 21.(1) At the same time as the Paediatric Committee adopts...

      3. Section 3 Modification of a paediatric investigation plan

        1. Article 22.If, following the decision agreeing the paediatric investigation plan, the...

      4. Section 4 Compliance with the paediatric investigation plan

        1. Article 23.(1) The competent authority responsible for granting marketing authorisation shall...

        2. Article 24.If, when conducting the scientific assessment of a valid application...

    4. CHAPTER 4 Procedure

      1. Article 25.(1) Within ten days of its receipt, the Agency shall...

    5. CHAPTER 5 Miscellaneous provisions

      1. Article 26.Any legal or natural person developing a medicinal product intended...

  4. TITLE III MARKETING AUTHORISATION PROCEDURES

    1. Article 27.Save where otherwise provided in this Title, marketing authorisation procedures...

    2. CHAPTER 1 Marketing authorisation procedures for applications falling within the scope of Articles 7 and 8

      1. Article 28.(1) Applications may be submitted in accordance with the procedure...

      2. Article 29.In the case of medicinal products authorised under Directive 2001/83/EC,...

    3. CHAPTER 2 Paediatric use marketing authorisation

      1. Article 30.(1) Submission of an application for a paediatric use marketing...

      2. Article 31.Without prejudice to Article 3(2) of Regulation (EC) No 726/2004, an application...

    4. CHAPTER 3 Identification

      1. Article 32.(1) Where a medicinal product is granted a marketing authorisation...

  5. TITLE IV POST-AUTHORISATION REQUIREMENTS

    1. Article 33.Where medicinal products are authorised for a paediatric indication following...

    2. Article 34.(1) In the following cases, the applicant shall detail the...

    3. Article 35.If a medicinal product is authorised for a paediatric indication...

  6. TITLE V REWARDS AND INCENTIVES

    1. Article 36.(1) Where an application under Article 7 or 8 includes...

    2. Article 37.Where an application for a marketing authorisation is submitted in...

    3. Article 38.(1) Where a paediatric use marketing authorisation is granted in...

    4. Article 39.(1) In addition to the rewards and incentives provided for...

    5. Article 40.(1) Funds for research into medicinal products for the paediatric...

  7. TITLE VI COMMUNICATION AND COORDINATION

    1. Article 41.(1) The European database created by Article 11 of Directive 2001/20/EC...

    2. Article 42.Member States shall collect available data on all existing uses...

    3. Article 43.(1) On the basis of the information referred to in...

    4. Article 44.(1) The Agency shall, with the scientific support of the...

    5. Article 45.(1) By 26 January 2008, any paediatric studies already completed,...

    6. Article 46.(1) Any other marketing authorisation holder-sponsored studies which involve the...

  8. TITLE VII GENERAL AND FINAL PROVISIONS

    1. CHAPTER 1 General provisions

      1. Section 1 Fees, community funding, penalties and reports

        1. Article 47.(1) Where an application for a paediatric use marketing authorisation...

        2. Article 48.The Community contribution provided for in Article 67 of Regulation (EC)...

        3. Article 49.(1) Without prejudice to the Protocol on the Privileges and...

        4. Article 50.(1) On the basis of a report from the Agency,...

      2. Section 2 Standing committee

        1. Article 51.(1) The Commission shall be assisted by the Standing Committee...

    2. CHAPTER 2 Amendments

      1. Article 52.Regulation (EEC) No 1768/92 is hereby amended as follows: in Article 1,...

      2. Article 53.In Article 11 of Directive 2001/20/EC, the following paragraph shall be...

      3. Article 54.In Article 6 of Directive 2001/83/EC, the first subparagraph of paragraph...

      4. Article 55.Regulation (EC) No 726/2004 is hereby amended as follows: Article 56(1) shall...

    3. CHAPTER 3 Final provisions

      1. Article 56.The requirement laid down in Article 7(1) shall not apply to...

      2. Article 57.(1) This Regulation shall enter into force on the thirtieth...

  9. Signature

  10. ATTACHMENTS

    1. COMMISSION STATEMENT

Yn ôl i’r brig

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