MEDICINES AND RELATED SUBSTANCES: SUBSIDIARY LEGISLATION
INDEX TO SUBSIDIARY LEGISLATION
Medicines and Related Substances (Prohibition of Use of Certain Medicines in Animals) Order
Medicines and Related Substances Regulations
MEDICINES AND RELATED SUBSTANCES REGULATIONS
(section 69)
(27th December, 2019)
ARRANGEMENT OF REGULATIONS
REGULATION
PART I
Preliminary
1. Citation
2. Interpretation
PART II
Medicines
3. Registration of medicine
4. Validity period of registration of medicine
5. Renewal of registration
6. Exemption from registration of medicines for individual patient
7. Import of unregistered medicines for personal use
8. Exemption from registration of medicines for wholesale
9. Exemption of donated unregistered medicines
10. Variations
11. Notifications
12. Recall of medicines by other institutions outside Botswana
13. Recall of medicines by Authority
14. Withdrawal of marketing authorisation
15. Suspension or revocation of marketing authorisation
PART III
Licensing
16. Licensing of pharmaceutical operations
17. Licensing of manufacturing facility
18. Licensing of pharmacy
19. Licensing of pharmaceutical wholesaler
20. Licensing of pharmacies within a group practice
21. Licensing of dispensaries in surgeries and institutional dispensaries
22. Variation of licence
23. Suspension or withdrawal of licence
24. Renewal of licence
PART IV
Record Keeping and Import of Medicines
25. Record keeping
26. Import of medicines
27. Parallel import of medicines
28. Import of samples for registration
29. Post-market surveillance
30. Adverse medicine reactions
31. Counterfeit medicines
32. Medicines in transit
33. Designation of ports
34. Disposal of unwanted medicines
35. Classification and description of medicines
36. Prescription of medicines
37. Contents of prescriptions
38. Emergency administration
39. General dispensing
40. Dispensing of Schedules 1A, 1B and 1C medicines
41. Emergency dispensing of Schedules 1A, 1B and 1C medicines
42. Dispensing of Schedule 2 medicines
43. Dispensing of Schedules 1D and 3 medicines
44. Emergency supply of medicines by pharmacist
45. Storage of medicines by prescribers
46. Dispensing of medicines by healthcare providers other than pharmacists
47. Sale and use of precursor chemicals
48. Storage of medicines
49. Product information
50. Import and export of narcotics, psychotropics and precursor chemicals
51. Records for narcotics, psychotropics and precursor chemicals
52. Correction of records
53. Advertising and promotion
54. Inspection of premises
PART V
Control of Clinical Trials
55. Application for use of medicines for clinical trials
56. Monitoring of clinical trial
57. Inspection and audit of clinical trials
58. Suspension or termination of approval to conduct clinical trials
59. Disposal of unused medicines in clinical trials
PART VI
Cosmetics
60. Registration of cosmetics
61. Exemption for registration of cosmetics
62. Publication of list of prohibited ingredients
63. Labelling of cosmetics
64. Licensing of manufacturing cosmetics
65. Import of cosmetics
PART VII
Complementary Medicines
66. Registration of complementary medicines
67. Validity period of registration of complementary medicines
PART VIII
General
68. Harmonisation and collaborative activities of Authority
69. Appeals Committee
70. Banned medicines
71. Offences and penalties
72. Revocation of Cap. 63:04 (Sub. Leg.)
S.I. 163, 2019.
PART I
Preliminary (regs 1-2)
These Regulations may be cited as the Medicines and Related Substances Regulations.
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