OpenLegislation

The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

S.I. 1994/3144 · Made 8 December 1994

Original text. legislation.gov.uk does not revise statutory instruments, so later amendments are not shown here. Changes made to it are listed under each provision when known.

MEDICINES

Made 8th December 1994

Laid before Parliament 9th December 1994

Coming into force 1st January 1995

The Secretary of State, in exercise of the powers conferred by section 2(2) of the European Communities Act 1972f1, being designated for the purpose of that section in relation to medicinal productsf2, hereby makes the following Regulations:

Annotations to the whole text

Footnotes

f1

1972 c. 68.

f2

See The European Communities (Designation) Order 1972 (S.I. 1972/1811).

Contents

  1. 1Citation, commencement and interpretation
  2. 2Responsibility for Member States' functions under the Regulations and Directives
  3. 3Marketing authorizations for relevant medicinal products
  4. 4Applications for the grant, renewal or variation of a United Kingdom marketing authorization
  5. 5Consideration, and grant or refusal, of an application for, or for renewal or variation of, a United Kingdom marketing authorization.
  6. 6Revocation, suspension or variation of a United Kingdom marketing authorization or the suspension of the use or marketing of medicinal products.
  7. 7Obligations of holders of marketing authorizations, and offences by holders of marketing authorizations and other persons
  8. 8Control of retail sale of supply of relevant medicinal products
  9. 9Consequential and other amendments of the Act and the Medicines Act 1971
  10. 10Application of enforcement provisions of the Act
  11. 11Other Schedules to have effect
  12. Signature
  13. Schedule 1: EXEMPTIONS AND EXCEPTIONS FROM THE PROVISIONS OF REGULATION 3
  14. 1Paragraph 1
  15. 2Paragraph 2
  16. 3Paragraph 3
  17. 4Paragraph 4
  18. 5Paragraph 5
  19. 6Paragraph 6
  20. 7Paragraph 7
  21. Schedule 2: PROCEDURAL PROVISIONS RELATING TO THE GRANT, REVOCATION AND SUSPENSION OF UNITED KINGDOM MARKETING AUTHORIZATIONS
  22. 1Interpretation
  23. 2Scope and application of the procedural provisions
  24. 3Scope and application of the procedural provisions
  25. 4Scope and application of the procedural provisions
  26. 5Requirement to consult the appropriate committee or the Medicines Commission
  27. 6Provisional opinion against authorization
  28. 7Licensing Authority’s decision
  29. 8Confirmation or alteration of the decision after taking into account the advice of the Medicines Commission
  30. 9Person appointed to hear representations
  31. 10Person appointed to hear representations
  32. 11Right to be heard by a person appointed or to make further representations
  33. 12Right to be heard by a person appointed or to make further representations
  34. 13Cases where suspension is to have immediate effect
  35. 14Cases where suspension is to have immediate effect
  36. Schedule 3: OFFENCES, PENALTIES ETC.
  37. 1Offences
  38. 2Offences
  39. 3Offences
  40. 4Offences
  41. 5Offences
  42. 6Offences
  43. 7Offences
  44. 8Offences
  45. 9Offences
  46. 10Offences
  47. 11Offences
  48. 12Offences
  49. 13Offences
  50. 14Penalties
  51. 15Miscellaneous
  52. 16Miscellaneous
  53. Schedule 4: MODIFICATIONS OF ENFORCEMENT PROVISIONS OF THE ACT
  54. 1Paragraph 1
  55. 2Paragraph 2
  56. 3Paragraph 3
  57. 4Paragraph 4
  58. 5Paragraph 5
  59. 6Paragraph 6
  60. 7Paragraph 7
  61. 8Paragraph 8
  62. 9Paragraph 9
  63. 10Paragraph 10
  64. 11Paragraph 11
  65. 12Paragraph 12
  66. 13Paragraph 13
  67. 14Paragraph 14
  68. Schedule 5: LABELS
  69. 1Interpretation
  70. 2Introductory
  71. 3Dispensed relevant medicinal products
  72. 4Delivery and storage
  73. 5Relevant medicinal products on a general sale list
  74. 6Relevant medicinal products not on a general sale list
  75. 7Prescription only relevant medicinal products
  76. 8Exemptions
  77. Schedule 6: TRANSITIONAL PROVISIONS
  78. 1Paragraph 1
  79. 2Paragraph 2
  80. 3Paragraph 3
  81. 4Paragraph 4
  82. 5Paragraph 5
  83. Schedule 7: CONSEQUENTIAL AMENDMENTS TO REGULATIONS
  84. 1Paragraph 1
  85. 2Paragraph 2
  86. 3Paragraph 3
  87. 4Paragraph 4
  88. 5Paragraph 5
  89. 6Paragraph 6
  90. 7Paragraph 7
  91. 8Paragraph 8
  92. 9Paragraph 9
  93. 10Paragraph 10
  94. 11Paragraph 11
  95. 12Paragraph 12
  96. 13Paragraph 13
  97. 14Paragraph 14
  98. 15Paragraph 15
  99. 16Paragraph 16
  100. 17Paragraph 17
  101. 18Paragraph 18
  102. 19Paragraph 19
  103. 20Paragraph 20
  104. 21Paragraph 21
  105. 22Paragraph 22
  106. Explanatory note