Part 3 Amendment of Part 3 (manufacture and distribution of medicinal products and active substances)

1. 13New regulation B17 and C17 (good manufacturing practice and good distribution practice)
2. 14Amendment of regulation 17 (manufacturing of medicinal products)
3. 15Amendment of regulation 18 (wholesale dealing in medicinal products)
4. 16Insertion of new regulation 18A (approved country for import)
5. 17Amendment of regulation 19 (exemptions from requirement for wholesale dealer’s licence)
6. 18Amendment of Schedule 3 (applications for licences under Part 3)
7. 19Amendment of regulation 23 (grant or refusal of licence)
8. 20Amendment of Schedule 4 (standard provisions of licences under Part 3)
9. 21Amendment of regulation 26 (general power to suspend, revoke or vary licences)
10. 22Amendment of Schedule 5 (review upon oral representations)
11. 23Amendment of regulation 29 (variation of licence on the application of the holder)
12. 24Amendment of regulation 31 (certification of manufacturer’s licence)
13. 25Amendment of regulation 33 (offence concerning data for advanced therapy medicinal products)
14. 26Amendment of Schedule 6 (manufacturer’s and wholesale dealer’s licences for exempt advanced therapy medicinal products)
15. 27Amendment of regulation 36 (conditions for manufacturer’s licence)
16. 28Amendment of regulation 37 (manufacturing and assembly)
17. 29Amendment of regulation 38 (imports)
18. 30Amendment of regulation 39 (further requirements for manufacturer’s licence)
19. 31Amendment of regulation 42 (conditions for wholesale dealer’s licence)
20. 32Amendment of Schedule 7 (qualified persons)
21. 33Amendment of regulation 43 (obligations of licence holder)
22. 34Omission of regulation 43A (requirement for wholesale dealer to decommission the unique identifier)
23. 35Amendment of regulation 44 (requirement for wholesale dealers to deal only with specified persons)
24. 36Amendment of regulation 45 (requirement as to responsible persons)
25. 37Insertion of new regulations 45AA and 45AB (responsible persons: import)
26. 38Amendment of regulation 45A (brokering in medicinal products)
27. 39Amendment of regulation 45D (grant or refusal of a broker’s registration)
28. 40Amendment of regulation 45E (criteria of broker’s registration)
29. 41Amendment of regulation 45F (provision of information)
30. 42Amendment of regulation 45M (criteria for importation, manufacture or distribution of an active substance)
31. 43Amendment of Schedule 7A (information to be provided for registration as an importer, manufacturer or distributor of active substances)
32. 44Amendment of regulation 45O (requirements for registration as an importer, manufacturer or distributor of an active substance)