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

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  1. Introductory Text

  2. 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

  3. 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

  4. 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

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