Part 2 Amendment of the Human Medicines Regulations 2012

1. 4Amendment of regulation 8
2. 5Amendment of regulation 17
3. 6Insertion of new regulations 17A and 17B (manufacturing of MM and POC medicinal products)
4. 7Amendment of regulation 20
5. 8Amendment of regulation 22
6. 9Amendment of regulation 26
7. 10Insertion of new regulation 27A (effect of suspension or variation relating to modular unit or POC site)
8. 11Amendment of regulation 29
9. 12Insertion of new regulations 29A and 29B (variation of MM and POC master files)
10. 13Amendment of regulation 37
11. 14Insertion of new regulations 37A and 37B (manufacturing and assembly of MM and POC medicinal products: additional requirements)
12. 15Amendment of regulation 39
13. 16Amendment of regulation 50
14. 17Insertion of new regulation 50K (applications relating to POC medicinal products)
15. 18Insertion of new regulations 74A and 74B (obligations to provide information relating to methods of manufacture and control)
16. 19Amendment of regulation 167
17. 20Amendment of regulation 167G
18. 21Amendment of regulation 169
19. 22Amendment of regulation 170
20. 23Insertion of new regulations 170A and 170B (pharmacovigilance requirements: MM and POC medicinal products)
21. 24Amendment of regulation 171
22. 25Amendment of regulation 175
23. 26Amendment of regulation 178
24. 27Amendment of regulation 188
25. 28Amendment of regulation 202A
26. 29Amendment of regulation 257
27. 30Amendment of regulation 257C
28. 31Insertion of new regulation 257CA (packaging requirements: POC medicinal products)
29. 32Amendment of regulation 258
30. 33Amendment of regulation 346
31. 34Amendment of Schedule 3
32. 35Amendment of Schedule 4
33. 36Amendment of Schedule 7
34. 37Amendment of Schedule 8
35. 38Amendment of Schedule 24