The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024

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1. Introductory Text

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   PART 1 General

   1. 1. Citation, commencement and extent

   2. 2. Amendment of the Human Medicines Regulations 2012

   3. 3. Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004

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   PART 2 Amendment of the Human Medicines Regulations 2012

   1. 4. Amendment of regulation 8

   2. 5. Amendment of regulation 17

   3. 6. Insertion of new regulations 17A and 17B (manufacturing of MM and POC medicinal products)

   4. 7. Amendment of regulation 20

   5. 8. Amendment of regulation 22

   6. 9. Amendment of regulation 26

   7. 10. Insertion of new regulation 27A (effect of suspension or variation relating to modular unit or POC site)

   8. 11. Amendment of regulation 29

   9. 12. Insertion of new regulations 29A and 29B (variation of MM and POC master files)

   10. 13. Amendment of regulation 37

   11. 14. Insertion of new regulations 37A and 37B (manufacturing and assembly of MM and POC medicinal products: additional requirements)

   12. 15. Amendment of regulation 39

   13. 16. Amendment of regulation 50

   14. 17. Insertion of new regulation 50K (applications relating to POC medicinal products)

   15. 18. Insertion of new regulations 74A and 74B (obligations to provide information relating to methods of manufacture and control)

   16. 19. Amendment of regulation 167

   17. 20. Amendment of regulation 167G

   18. 21. Amendment of regulation 169

   19. 22. Amendment of regulation 170

   20. 23. Insertion of new regulations 170A and 170B (pharmacovigilance requirements: MM and POC medicinal products)

   21. 24. Amendment of regulation 171

   22. 25. Amendment of regulation 175

   23. 26. Amendment of regulation 178

   24. 27. Amendment of regulation 188

   25. 28. Amendment of regulation 202A

   26. 29. Amendment of regulation 257

   27. 30. Amendment of regulation 257C

   28. 31. Insertion of new regulation 257CA (packaging requirements: POC medicinal products)

   29. 32. Amendment of regulation 258

   30. 33. Amendment of regulation 346

   31. 34. Amendment of Schedule 3

   32. 35. Amendment of Schedule 4

   33. 36. Amendment of Schedule 7

   34. 37. Amendment of Schedule 8

   35. 38. Amendment of Schedule 24

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   PART 3 Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004

   1. 39. Amendment of regulation 2

   2. 40. Amendment of regulation 13

   3. 41. Amendment of regulation 36

   4. 42. Insertion of new regulations 36A and 36B (manufacture of MM and POC investigational medicinal products)

   5. 43. Amendment of regulation 39

   6. 44. Amendment of regulation 41

   7. 45. Amendment of regulation 44

   8. 46. Insertion of new regulations 44A and 44B (variation of master files)

   9. 47. Amendment of regulation 45

   10. 48. Amendment of regulation 46

   11. 49. Amendment of regulation 48

   12. 50. Amendment of regulation 49

   13. 51. Amendment of Schedule 6

   14. 52. Amendment of Schedule 7

5. Signature

6. Explanatory Note