Medicines Act (Cap. 458)

Inhoud

1. Art. 1 Short title.
2. PART I
3. Art. 2 Interpretation.
4. Title I - The Licensing Authority
5. Art. 3 Functions of the Licensing Authority.
6. Title II - The Medicines Authority
7. Art. 4 Establishment of the Medicines Authority.
8. Art. 5 Legal personality of the Medicines Authority.
9. Art. 6 Functions of the Medicines Authority.
10. Art. 7 Organisationof the Medicines Authority.
11. Art. 8 The Chief Executive Officer of the Medicines Authority.
12. Art. 9 Employees of the Medicines Authority.
13. Art. 10 Accounts of the Medicines Authority.
14. Art. 11 Procurementbythe Medicines Authority.
15. Art. 12 Applicabilityofthe Code of Ethics.
16. Art. 13 Exemption from tax, etc.
17. Title III - Medicines Review Board
18. Art. 14 Establishment of Medicines Review Board. Cap. 12.
19. Art. 15 Medicines Review Board may appoint advisors.
20. Art. 16 Functions of the Medicines Review Board.
21. Art. 17 Procedure of appeal.
22. Art. 18 Public hearing.
23. PART III
24. Art. 19 Applicability of certain provisions.
25. Title I - Marketing Authorisation Relating to Medicinal Products
26. Art. 20 Authorisation to place medicinal products on the market.
27. Art. 21 Review or appeal.
28. Art. 22 Granting of marketing authorisation.
29. Art. 23 Notification of marketing authorisation.
30. Art. 24 Validity of market authorisation.
31. Art. 25 Application of renewal.
32. Art. 26 Notification of refusal.
33. Art. 27 Refusal to renew marketing authorisation.
34. Art. 28 Suspension or revocation of marketing authorisation.
35. Art. 29 Classification of medicinal products.
36. Art. 30 List of medicinal products having a marketing authorisation.
37. Art. 31 Advertising of medicinal products.
38. Art. 31A Marketing authorisation holderstoabideby standards.
39. Art. 32 Homeopathic medicinal products.
40. Art. 33 Products derived from human blood or human plasma.
41. Art. 34 Radio- pharmaceutical medicinal product.
42. Art. 35 Immunological medicinal products.
43. Art. 36 Herbal medicinal products.
44. Title II - Manufacture of Medicinal Products for Human Use
45. Art. 37 Manufacturer’s licence.
46. Art. 38 Application for manufacturer’s licence.
47. Art. 39 Granting of manufacturer’s licence.
48. Art. 40 Notice for further information.
49. Art. 41 Suspension or revocation of manufacturer’s licence.
50. Art. 42 Inspection in relation to manufacturers, etc.
51. Art. 43 Duration and renewal of manufacturer's licence.
52. Art. 44 Responsibilities of manufacturer’s licence holder.
53. Art. 45 Responsibilities of the qualified person.
54. Art. 46 Suspension of activity of a qualified person.
55. Art. 47 Change in conditions of manufacturer’s licence.
56. Art. 48 Obligations of Licensing Authority.
57. Art. 49 Manufacture of homeopathic medicinal products.
58. Art. 50 Manufacture of medicinal products derived from human blood and human plasma, etc.
59. Art. 51 Manufacture of radio- pharmaceuticals.
60. Art. 52 Immunological medicinal product.
61. Art. 53 Herbal medicinal products.
62. Title III - Wholesale Distribution and Brokering of Medicinal
63. Art. 54 Wholesale dealing.
64. Art. 54A Brokering.
65. Art. 55 Application for a wholesale dealer’s licence.
66. Art. 56 Granting of a wholesale dealer’s licence.
67. Art. 57 Notice for further information.
68. Art. 58 Duration and renewal of wholesale dealer’s licence.
69. Art. 59 Obligations of holder of wholesale dealer’s licence.
70. Art. 60 Responsibilities of the responsible person.
71. Art. 60A Suspension of responsible person.
72. Art. 61 Suspension or revocation of wholesale dealer’s licence.
73. Art. 62 Change in conditions of a wholesale dealer’s licence.
74. Art. 63 Obligations of Licensing Authority.
75. Art. 64 Inspecting in relation to wholesale.
76. Art. 65 Special provisions.
77. Title IV - Pharmacies and Related Pharmaceutical Activity
78. Art. 66 Licence to open a pharmacy.
79. Art. 67 Application for a pharmacy licence.
80. Art. 68 Grant of a pharmacy licence.
81. Art. 69 Notice for further information.
82. Art. 70 Duration and renewal of pharmacy licence.
83. Art. 71 Transfer of a pharmacy licence.
84. Art. 72 Suspension or revocation of pharmacy licence.
85. Art. 73 Temporary closure of pharmacy.
86. Art. 74 Obligations of the holder of a pharmacy licence.
87. Art. 75 Managing pharmacist.
88. Art. 75A Suspension of managing pharmacist.
89. Art. 76 Duties of pharmacist.
90. Art. 77 Interest in a pharmacy.
91. Art. 78 Licensee may employ one or more pharmacists.
92. Art. 79 Medicinalproducts to be sold from a pharmacy.
93. Art. 80 Dispensing of a medicinal product.
94. Art. 81 Dispensing against prescription.
95. Art. 82 Presentation of a prescription.
96. Art. 83 Labelling of dispensed products.
97. Art. 84 Disposal of expired, deteriorated or imperfect products. Cap. 449.
98. Art. 85 Storage of medicinal products in pharmacy.
99. Art. 86 Premises, etc., in accordance with requirements and standards.
100. Art. 87 Pharmacist to be guided by set standards.
101. Art. 88 Inspections of pharmacies.
102. Art. 89 Opening of pharmacies.
103. PART IV
104. Art. 90 Definition of poisons.
105. Art. 91 Keeping, etc., of poisons.
106. Art. 92 Licence for sale of poisons.
107. Art. 93 Keeping of poisonous substancesinasafe place.
108. Art. 94 Sale of poisonous substances.
109. Art. 95 Power of inspection.
110. Art. 96 Poisoned grain, seed etc., Cap. 430.
111. PART V
112. Art. 97 Special restrictions on persons to be supplied with medicinal products.
113. Art. 98 Adulteration of medicinal products.
114. PART VI
115. Art. 99 Offences and penalties.
116. Art. 100 Special procedure.
117. PART VII
118. Art. 101 Right of entry.
119. Art. 101A Requirements for testing and inspections of manufacturers, importers, brokers and distributors of medicinal products,including APIs, excipients and other starting materials.
120. Art. 102 Power to inspect, take samples and seize goods and documents.
121. Art. 103 Application of sampling procedure to substanceorarticle seized.
122. Art. 104 Supplementary provisions as to right of entry.
123. Art. 104A Hindering, etc., the Licensing Authority.
124. Art. 104B Proof of controls carried out.
125. Art. 104C Recalls and rapid alerts.
126. PART VIII
127. Art. 105 Recognition of equivalent standards.
128. Art. 106 Power of Minister to make regulations.
129. Art. 107 Transitory provision. Amendment of Medical and Kindred Professions Ordinance. Cap. 31.
130. Art. 109 Saving. Cap. 31.
131. Art. 109A Designation of competent authority.
132. Art. 110 Saving provisions.
133. Art. 111 Medical devices and in vitro diagnosticmedical devices.
134. Art. 112 Language.