Schedule 10A Variations to a UK marketing authorisationF1

1. 1Interpretation
2. 2Classification of variations
3. 3Licensing authority recommendation on unclassified variations
4. 4Variations leading to the revision of product information
5. 5Grouping of variations
6. 6Notification procedure for minor variations of type IA
7. 7Notification procedure for minor variations of type IB
8. 8Prior approval procedure for major variations of type II
9. 9Elements to be submitted
10. 10Measures to close the procedures specified in paragraphs 6 to 8
11. 11Extensions of marketing authorisations
12. 12Human influenza vaccines
13. 13Pandemic situation with respect to human influenza
14. 14Urgent safety restrictions
15. 15Amendments to the decision granting the marketing authorisation
16. 16Implementation of variations
17. 17Continuous monitoring