Pharmacovigilance Regulations (S.L. 458.35)

Inhoud

1. Art. 1 Citation, purpose and scope.
2. Art. 2 Interpretation. Cap. 458. Cap. 458.
3. Art. 3 Setting up of pharmacovigilance system.
4. Art. 4 Power to delegate.
5. Art. 5 Information to the Commission.
6. Art. 6 Duty of the marketing authorisation holder.
7. Art. 7 Derogation.
8. Art. 8 The Authority may impose obligation.
9. Art. 9 Opportunity to file written observations.
10. Art. 10 Authority may withdraw or confirm obligation.
11. Art. 11 Management of funds intended for activities connected with pharmacovigilance
12. Art. 12 Authority not precluded from charging fees.
13. Art. 13 Transparency and communications.
14. Art. 14 Public announcements.
15. Art. 15 Recording, reporting and assessment of pharmacovigilance data.
16. Art. 16 Electronic reports of adverse reactions.
17. Art. 17 Eudravigilance database.
18. Art. 18 Non-serious suspected adverse reactions.
19. Art. 19 Procedures to obtain data.
20. Art. 20 Collaboration with Agency and Member States.
21. Art. 21 Recording suspected adverse reactions.
22. Art. 22 Submission of reports.
23. Art. 23 Report follow-up.
24. Art. 24 Detection of duplicates.
25. Art. 25 Reports of serious suspected adverse reactions.
26. Art. 26 Access to reports through Eudravigilance database.
27. Art. 27 Reactions arising from an error.
28. Art. 28 Additional obligations may not be imposed.
29. Art. 29 Periodic safety update reports.
30. Art. 30 Agency to make reports available.
31. Art. 31 When reports are to be submitted.
32. Art. 32 Frequency and dates of submission.
33. Art. 33 Authorisations granted before the 21st July 2012.
34. Art. 34 Medicinalproducts authorised only in one Member State.
35. Art. 35 Harmonised frequency for submission of reports.
36. Title II of Regulation (EC) No 726/2004;
37. Art. 36 Community reference date.
38. Art. 37 Marketing authorisation holders may submit requests.
39. Art. 38 Publication of referencedatesand reports.
40. Art. 39 Effective date of changes.
41. Art. 40 Assessment by the Authority of periodic safety update reports.
42. Art. 41 Single assessment of periodic safety update reports.
43. Art. 42 Conducting the single assessment.
44. Art. 43 Assessment report.
45. Art. 44 Submission of comments.
46. Art. 45 Rapporteur to update assessment report.
47. Art. 46 Authority to consider necessity of any action.
48. Art. 47 Coordination group to consider the report.
49. Art. 48 Deliberations of the coordination group.
50. Art. 49 Adoption of an opinion on marketing authorisations.
51. Art. 50 Detailed explanation of scientific grounds.
52. Art. 51 Decisions to be adopted by the Commission.
53. Art. 52 Decision on measures relating to marketing authorisations.
54. Art. 53 Signal detection.
55. Art. 54 Analysis and prioritisation of risk signals.
56. Art. 55 Mutual information about risks.
57. Art. 56 Duties of the Authority on information about risks.
58. Art. 57 UrgentCommunity procedure.
59. Art. 58 Supervision of post-authorisation safety studies.
60. Art. 59 Submission of draft protocol.
61. Art. 60 Authorisation of amendments.
62. Art. 61 Finalisation of the study.
63. Art. 62 Recommendations to vary, suspend, withdraw marketing authorisations.