Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examin... (32008R1234)
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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)
- 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)
- 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
- ANNEX II
- Classification of variations
- ANNEX III
- Cases for grouping variations referred to in Article 7(2)(b)
- ANNEX IV
- Elements to be submitted
- ANNEX V
- PART 1
- PART 2
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