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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)
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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
CHAPTER III VARIATIONS TO CENTRALISED MARKETING AUTHORISATIONS
SECTION 2 Amendments to the decision granting the marketing authorisation and implementation
Cases for grouping variations referred to in Article 7(2)(b) and Article 13d(2)(b)
4. All variations in the group relate solely to changes of...
6. All variations in the group relate to a project intended...
7. All variations in the group are changes affecting the quality...
8. All variations in the group are changes to the pharmacovigilance...
9. All variations in the group are consequential to a given...
10. All variations in the group relate to the implementation of...
11. All variations in the group are consequential to the assessment...
12. All variations in the group are consequential to a given...
13. All variations in the group are consequential to a specific...
14. All variations in the group are consequential to a specific...
1. A list of all the marketing authorisations affected by the...
2. A description of all the variations submitted, including:
3. All necessary documents as listed in the guidelines referred to...
5. In the case of variations to centralised marketing authorisations, the...
6. In the case of variations to marketing authorisations granted by...
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