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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)- Recitals
CHAPTER I — GENERAL PROVISIONS- 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 IIa — VARIATIONS TO PURELY NATIONAL MARKETING AUTHORISATIONS
- Article 13a — Notification procedure for minor variations of type IA
- Article 13b — Notification procedure for minor variations of type IB
- Article 13c — Prior Approval procedure for major variations of type II
- Article 13d — Grouping of variations to purely national marketing authorisations
- Article 13e — Measures to close the procedures of Articles 13a to 13c
- Article 13f — Human influenza vaccines
- 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
- CHAPTER V — FINAL PROVISIONS
- Final
- ANNEX I — Extensions of marketing authorisations
- ANNEX II — Classification of variations
- ANNEX III — Cases for grouping variations referred to in Article 7(2)(b) and Article 13d(2)(b)
- ANNEX IV — Elements to be submitted
- ANNEX V — PART 1
- ANNEX VI — List of Member States referred in Article 24a