European Commission 24 November 2008, 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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European Union · · · Cited by 887 · 24-11-2008

CHAPTER I. GENERAL PROVISIONS
Article 1. Subject matter and scope
Article 2. Definitions
Article 3. Classification of variations
Article 4. Guidelines
Article 5. Recommendation on unforeseen variations
Article 6. Variations leading to the revision of product information
Article 7. Grouping of variations
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
Article 8. Notification procedure for minor variations of type IA
Article 9. Notification procedure for minor variations of type IB
Article 10. ‘Prior Approval’ procedure for major variations of type II
Article 11. Measures to close the procedures of Articles 8 to 10
Article 12. Human influenza vaccines
Article 13. Coordination group and arbitration
CHAPTER III. VARIATIONS TO CENTRALISED MARKETING AUTHORISATIONS
Article 14. Notification procedure for minor variations of type IA
Article 15. Notification procedure for minor variations of type IB
Article 16. ‘Prior Approval’ procedure for major variations of type II
Article 17. Measures to close the procedures of Articles 14 to 16
Article 18. Human influenza vaccines
CHAPTER IV.
SECTION 1. Special procedures
Article 19. Extensions of marketing authorisations
Article 20. Worksharing procedure
Article 21. Pandemic situation with respect to human influenza
Article 22. Urgent safety restrictions
SECTION 2. Amendments to the decision granting the marketing authorisation and implementation
Article 23. Amendments to the decision granting the marketing authorisation
Article 24. Implementation of variations
CHAPTER V. FINAL PROVISIONS
Article 25. Continuous monitoring
Article 26. Review
Article 27. Repeal and transitional provision
Article 28. Entry into force
ANNEX I. Extensions of marketing authorisations

12.12.2008

Official Journal of the European Union

L 334/7

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)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty

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