Part 5 Amendment of Part 5 (marketing authorisations)

1. 47Amendment of regulation 48 (application of Part 5)
2. 48Amendment of regulation 49 (application for grant of UK marketing authorisation or parallel import licence)
3. 49Amendment of regulation 50 (accompanying material)
4. 50Amendment of Schedule 8 (material to accompany an application for a UK marketing authorisation)
5. 51Amendment of Schedule 8A (material to accompany an application for a parallel import licence)
6. 52Amendment of Schedule 9 (undertakings by non-United Kingdom manufacturers)
7. 53New regulation 50A to 50J (applications in relation to particular medicinal products)
8. 54Insertion of new Schedule in relation to orphan provisions
9. 55Amendment of Schedule 10 (national homoeopathic products)
10. 56Substitution of regulation 51 (applications relating to generic medicinal products)
11. 57Amendment of regulation 52 (applications relating to certain medicinal products that do not qualify as generic etc)
12. 58Amendment of regulation 53 (applications relating to similar biological medicinal products)
13. 59Amendment of regulation 54 (applications relating to products in well-established medicinal use)
14. 60Amendment of regulation 55 (applications relating to new combinations of active substances)
15. 61Amendment of regulation 56 (applications containing information supplied in relation to another product with consent)
16. 62Amendment of regulation 58 (consideration of application)
17. 63Amendment of Schedule 11 (advice and representations)
18. 64Insertion of provisions concerning consideration of certain applications for UK marketing authorisations
19. 65Amendment of regulation 59 (conditions of UK marketing authorisation or parallel import licence: general)
20. 66Amendment of regulation 60 (conditions of UK marketing authorisation: exceptional circumstances)
21. 67Insertion of new regulations 60A (condition as to the submitting of samples and other information to the appropriate authority)
22. 68Amendment of regulation 61 (conditions of UK marketing authorisation)
23. 69Amendment of regulation 64 (duties of licensing authority in connection with determination)
24. 70Obligation of licensing authority in case of change of classification
25. 71Amendment of regulation 65 (validity of UK marketing authorisation)
26. 72Validity of conditional marketing authorisation and variation of a UK marketing authorisation
27. 73Insertion of new Schedule 10A (variations to a UK marketing authorisation)
28. 74Amendment of regulation 66 (application for renewal of authorisation)
29. 75Amendment of regulation 66A (application for renewal of a parallel import licence)
30. 76Renewal of conditional marketing authorisation
31. 77Amendment of regulation 68 (revocation, variation and suspension of UK marketing authorisation or parallel import licence)
32. 78Amendment of regulation 69 (suspension of use etc of relevant medicinal product)
33. 79Omission of regulation 70 (authorisations granted under Chapter 4 of Title III of the 2001 Directive
34. 80Amendment of regulation 71 (withdrawal of medicinal product from the market)
35. 81Amendment of regulation 72 (sale etc of suspended medicinal product)
36. 82Amendment of regulation 73 (obligation to notify placing on the market etc)
37. 83Amendment of regulation 75 (obligation to provide information relating to safety etc)
38. 84Amendment of regulation 76 (obligation in relation to product information)
39. 85Amendment of regulation 77 (record-keeping obligations)
40. 86Amendment of regulation 78 (obligation to ensure appropriate and continued supplies)
41. 87Post authorisation requirements in relation to UK marketing authorisations with paediatric aspects and advanced therapy medicinal products
42. 88Omission of regulation 79 (failure to provide information on marketing authorisations to EMA)
43. 89Amendment of regulation 80 (urgent safety restrictions)
44. 90Omission of regulations 81 to 94 (offences relation to EU marketing authorisations)
45. 91Omission of regulation 94A (offences relating to Commission Regulation 2016/161)
46. 92Amendment of regulation 95 (offences in connection with application)
47. 93Amendment of regulation 96 (provision of misleading information)
48. 94Amendment of regulation 97 (breach of pharmacovigilance condition)
49. 95Amendment of regulation 98 (general offence of breach of Part 5)
50. 96Amendment of regulation 99 (penalties)
51. 97Amendment of regulation 101 (defences)