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Commission Regulation (EC) No 1234/2008Dangos y teitl llawn

Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance)

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  1. Introductory Text

  2. CHAPTER I GENERAL PROVISIONS

    1. Article 1.Subject matter and scope

    2. Article 2.Definitions

    3. Article 3.Classification of variations

    4. Article 4. Guidelines

    5. Article 5.Recommendation on unforeseen variations

    6. Article 6.Variations leading to the revision of product information

    7. Article 7. Grouping of variations

  3. CHAPTER II VARIATIONS TO MARKETING AUTHORISATIONS GRANTED IN ACCORDANCE WITH DIRECTIVE 87/22/EEC, CHAPTER 4 OF DIRECTIVE 2001/82/EC OR CHAPTER 4 OF DIRECTIVE 2001/83/EC

    1. Article 8.Notification procedure for minor variations of type IA

    2. Article 9.Notification procedure for minor variations of type IB

    3. Article 10.‘Prior Approval’ procedure for major variations of type II

    4. Article 11.Measures to close the procedures of Articles 8 to 10

    5. Article 12.Human influenza vaccines

    6. Article 13.Coordination group and arbitration

  4. CHAPTER III VARIATIONS TO CENTRALISED MARKETING AUTHORISATIONS

    1. Article 14.Notification procedure for minor variations of type IA

    2. Article 15.Notification procedure for minor variations of type IB

    3. Article 16.‘Prior Approval’ procedure for major variations of type II

    4. Article 17. Measures to close the procedures of Articles 14 to 16

    5. Article 18.Human influenza vaccines

  5. CHAPTER IV

    1. SECTION 1 Special procedures

      1. Article 19.Extensions of marketing authorisations

      2. Article 20.Worksharing procedure

      3. Article 21.Pandemic situation with respect to human influenza

      4. Article 22.Urgent safety restrictions

    2. SECTION 2 Amendments to the decision granting the marketing authorisation and implementation

      1. Article 23.Amendments to the decision granting the marketing authorisation

      2. Article 23a.The statement indicating compliance with the agreed completed paediatric investigation...

      3. Article 24. Implementation of variations

  6. CHAPTER V FINAL PROVISIONS

    1. Article 25.Continuous monitoring

    2. Article 26.Review

    3. Article 27.Repeal and transitional provision

    4. Article 28.Entry into force

  7. Signature

    1. ANNEX I

      Extensions of marketing authorisations

      1. 1. Changes to the active substance(s):

      2. 2. Changes to strength, pharmaceutical form and route of administration:

      3. 3. Other changes specific to veterinary medicinal products to be administered...

    2. ANNEX II

      Classification of variations

      1. 1. The following variations shall be classified as minor variations of...

      2. 2. The following variations shall be classified as major variations of...

    3. ANNEX III

      Cases for grouping variations referred to in Article 7(2)(b)

      1. 1. One of the variations in the group is an extension...

      2. 2. One of the variations in the group is a major...

      3. 3. One of the variations in the group is a minor...

      4. 4. All variations in the group relate solely to changes of...

      5. 5. All variations in the group are changes to an Active...

      6. 6. All variations in the group relate to a project intended...

      7. 7. All variations in the group are changes affecting the quality...

      8. 8. All variations in the group are changes to the pharmacovigilance...

      9. 9. All variations in the group are consequential to a given...

      10. 10. All variations in the group relate to the implementation of...

      11. 11. All variations in the group are consequential to the assessment...

      12. 12. All variations in the group are consequential to a given...

      13. 13. All variations in the group are consequential to a specific...

      14. 14. All variations in the group are consequential to a specific...

    4. ANNEX IV

      Elements to be submitted

      1. 1. A list of all the marketing authorisations affected by the...

      2. 2. A description of all the variations submitted, including:

      3. 3. All necessary documents as listed in the guidelines referred to...

      4. 4. Where a variation leads to or is the consequence of...

      5. 5. In the case of variations to centralised marketing authorisations, the...

      6. 6. In the case of variations to marketing authorisations granted by...

    5. ANNEX V

      1. PART 1

      2. PART 2

        1. 1. Variations concerning a change to or addition of a non-food...

        2. 2. Variations concerning the replacement or addition of a serotype, strain,...

        3. 3. Variations concerning the replacement of a strain for a veterinary...

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