OpenLegislation

The Medicines (Products for Human Use) (Fees) Regulations 2016

S.I. 2016/190 · Made 11 February 2016 · Extends to United Kingdom

Up to date with all changes known to legislation.gov.uk, revised to 28 April 2026.

Medicines

Fees And Charges

Made 11th February 2016

Laid before Parliament 24th February 2016

Coming into force 1st April 2016

The Secretary of State for Health and the Minister for Health, Social Services and Public Safety, acting jointly, make the following Regulations in exercise of the powers conferred on them by section 1(1) and (2) of the Medicines Act 1971 M1 or, in the case of the Minister, the powers conferred by those provisions and now vested in him M2.

In so far as these Regulations are not made under section 1(1) and (2) of the Medicines Act 1971, the Secretary of State makes these Regulations in exercise of the powers conferred on him by section 2(2) of the European Communities Act 1972 M3 and section 56(1) and (2) of the Finance Act 1973 M4. The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to medicinal products M5.

The Treasury has consented to the making of these Regulations as required by section 1(1) of the Medicines Act 1971 and section 56(1) of the Finance Act 1973.

In accordance with section 129(6) of the Medicines Act 1968 M6, the Secretary of State for Health and the Minister for Health, Social Services and Public Safety have consulted with such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations.

Annotations to the whole text

Marginal citations

M1

1971 c.69; as amended by regulation 45(2) of S.I. 2008/2297 and section 21 of the Health and Medicines Act 1988 (c.49). By virtue of section 1(3) of the Medicines Act 1971 (“the 1971 Act”), expressions used in that section have the same meaning as in the Medicines Act 1968 (c.67) (“the 1968 Act”). See therefore section 1 of the 1968 Act, as substituted by paragraph 2 of Schedule 34 to the Human Medicines Regulations 2012 (S.I. 2012/1916) (“the 2012 Regulations”) which provides the meaning of the expression “the Ministers”, which is relevant to the powers being exercised in the making of these Regulations. By virtue of regulation 348 of, and paragraph 36 of Schedule 34 to, the 2012 Regulations, references in section 1(1) and (2)(b) of the 1971 Act to an application for a licence, or for the variation or renewal of such a licence under Part 2 of the 1968 Act, shall have effect as a reference to any application under Parts 3 to 8 of the 2012 Regulations.

M2

In the case of the Secretary of State, by virtue of article 2(1) of S.I. 1999/3142. In the case of the Minister for Health, Social Services and Public Safety, by virtue of section 95(5) of, and paragraph 10 of Schedule 12 to, the Northern Ireland Act 1998 (c.47); the Department for which the Minister is responsible was renamed by virtue of Article 3(6) of S.I. 1999/283 (N.I.1).

M3

1972 c.68. Section 2(2) was amended by section 27(1)(a) of the Legislative and Regulatory Reform Act 2006 (c.51) and section 3(3) of and Part 1 of the Schedule to the European Union (Amendment) Act 2008 (c.7).

M4

1973 c.51. Section 56(1) was amended by article 6(1)(e) of the Treaty of Lisbon (Changes of Terminology) Order 2011 (S.I. 2011/1043).

M5

See article 2(1) of and Schedule 1 to the European Communities (Designation) Order 1972 (S.I. 1972/1811).

M6

Section 129(6) was extended by section 1(3)(b) of the Medicines Act 1971.

Contents

  1. Part 1: General
  2. 1Citation and commencement
  3. 2Interpretation
  4. Part 2: Capital Fees for Pre-Application Meetings
  5. 3Interpretation of Part 2
  6. 3AFee for scientific or other advice
  7. 4Fee for scientific advice: application for, or variation to, EU marketing authorisation Repealed
  8. 5Fee for scientific advice: classification of a medicinal product
  9. 6Fee for advertising advice Repealed
  10. 7Fee for pharmacovigilance advice Repealed
  11. 8Fee for advice on labelling or leaflets
  12. 9Fee for regulatory advice Repealed
  13. 10Fee for advice for other purposes Repealed
  14. 10AWaiver for advice given to small and medium companies
  15. 11Time for payment of fees under regulations 3A to 8
  16. Part 3: Capital Fees for Applications for Authorisations, Registrations, Licences or Certificates and for Associated Inspections
  17. 12Fees for applications for authorisations, registrations, licences or certificates etc.
  18. 13Fee for application to be included on the list of online sellers of medicines
  19. 14Fee for applications for additional copy certificates
  20. 15Fees for applications for certificates and copy certificates by exporters of medicinal products
  21. Part 4: Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States
  22. 16Meaning of “set of applications”
  23. 17Fees for applications for regulatory assistance under the mutual recognition procedure
  24. 18Time for payment of fees under regulation 17
  25. Part 5: Capital Fees for Applications for Variations of Authorisations, Registrations and Licences and for Associated Compliance Activities
  26. 19Fees for variations of authorisations, registrations and licences
  27. 19AFees for certification of plasma master files
  28. 19BFee for certification of vaccine antigen master files
  29. 19CFees for assessment of post-authorisation safety studies
  30. 19DFee for carrying out a major safety review
  31. 19EFee for assessment of periodic safety update reports
  32. 19EAFee for assessment of clinical trial annual safety reports
  33. 19FFee for testing of samples by the appropriate authority
  34. 19GTime for payment of fees under regulations 19A to 19F
  35. 20Fees for modifications to clinical trial authorisations
  36. 21Fees for notification of changes and reports for broker's registrations
  37. 22Fees for notification of changes and compliance Reports for active substance registrations
  38. 23Applications for multiple variations
  39. Part 6: Capital Fees for Assessment of Labels and Leaflets
  40. 24Meaning of “set of proposed changes”
  41. 25Fees for assessment of a set of proposed changes to labels and leaflets
  42. 26Time for payment of fees under regulation 25
  43. Part 7: Capital Fees for Applications for Renewals of Certain Licences, Authorisations and Registrations and for Associated Inspections
  44. 27Fees for renewals of certain manufacturer's licences
  45. 27AFee for renewals of a marketing authorisation
  46. 28Fees for renewals in terms which are not identical to the existing authorisation, licence or registration
  47. Part 8: Capital Fees for Regulatory Assistance Given by the United Kingdom Acting as Reference Member State Relating to the Assessment of Applications for the Renewal of Specified Marketing Authorisations Repealed
  48. 29Fees for regulatory assistance for certain marketing authorisations Repealed
  49. Part 9: Capital Fees for Inspections
  50. 30Fees for inspections
  51. 31Fees for inspections of pharmacovigilance service providers
  52. 32Payer of inspection fee (contract laboratories and API manufacturing sites)
  53. 33Inspections in connection with multiple applications
  54. 34Fees for inspections relating to good clinical practice in clinical trials
  55. 35Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer's licence
  56. 36Adjustment and refund of inspection fees in respect of a wholesale dealer's licence
  57. 37Amount, and time for payment, of inspection fees in respect of an application for a broker's registration or an active substance registration
  58. Part 10: Periodic Fees for Authorisations, Registrations and Licences
  59. 38Periodic fees
  60. 39Periodic fee for persons included on the list of online sellers of medicines
  61. Part 11: Capital Fees for Application for Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership
  62. 40Meaning of “good clinical practice accreditation scheme”
  63. 41Fees for applications for membership and certificates
  64. Part 12: Capital Fee for a Review Upon Oral Representations or a Person Appointed Hearing
  65. 42Fee for a review upon oral representations or a person appointed hearing
  66. 43Time for payment under regulation 42
  67. Part 13: Fees in relation to the Part 6 of the Human Medicines Regulations (certification of homoeopathic medicinal products)
  68. 44Interpretation
  69. 45Fees for applications made at the invitation of the licensing authority
  70. 46Fees for applications for certificates
  71. 47Fees for variations of certificates
  72. 48Time for payment of fees
  73. Part 14: Administration
  74. 49Payment of fees to Ministers
  75. 50Time for payment of capital fees in connection with applications or inspections
  76. 51Time for payment of capital fees – applications made by small companies
  77. 52Payment of fees in respect of a traditional herbal registration
  78. 53Time for payment of periodic fees
  79. 54Penalty fees for late payment of periodic fees
  80. 55Daily penalty fees for late payment of periodic fees
  81. 56Refund or waiver of fees under regulation 54 or 55
  82. 57Adjustment, waiver, reduction or refund of fees
  83. 58Suspension of licences and authorisations
  84. 59Civil proceedings to recover unpaid fees
  85. Part 15: Amendments to Other Legislation
  86. 60Amendment of the Medical Devices (Consultation Requirements) (Fees) Regulations 1995
  87. 61Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004
  88. 62Amendment of the Human Medicines Regulations 2012
  89. Part 16: Revocations and Savings
  90. 63The Medicines (Products for Human Use) (Fees) Regulations 2013
  91. Signature
  92. Schedule 1: General interpretation provisions
  93. 1Paragraph 1
  94. 2Paragraph 2
  95. 3Paragraph 3
  96. 4Paragraph 4
  97. 5Paragraph 5
  98. Schedule 2: Capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates
  99. Part 1: General: interpretation and categories of applications and variations
  100. 1Interpretation
  101. 2General: categories of Applications and Variations
  102. 3Administrative variation application
  103. 4Extension application
  104. 5Complex application
  105. 6Complex registration application
  106. 7Complex variation application
  107. 8Decentralised procedure application
  108. 9Extended Type II Complex Variation Application
  109. 10Major application
  110. 11Mutual recognition procedure incoming application
  111. 12New excipient variation application
  112. 13New indication variation application
  113. 14Parallel Import Licence application
  114. 15Reclassification variation application
  115. 16Reduced registration application
  116. 17Simple application
  117. 18Standard application
  118. 19Standard registration application
  119. 20Standard variation application
  120. 21Standard variation application for a homoeopathic medicinal product
  121. 22Type IB and Type II Applications
  122. 23Type II Complex Variation Application
  123. Part 2: Capital Fees for Applications for Authorisations, Licences, Registrations and Certificates
  124. 24Marketing authorisations
  125. 24AFees where an application for a European Union marketing authorisation had been made before IP completion day
  126. 25Fees where application includes reclassification
  127. 26Fees where person holds clinical trial certificate
  128. 27Joint development
  129. 28Application for multiple authorisations
  130. 28AApplication by pre-assessment of modules
  131. 29Authorisation for a national homoeopathic product
  132. 30Manufacturer's licences and authorisations
  133. 31Wholesale dealer's licences
  134. 32Broker's registrations
  135. 33Active substance registrations
  136. 34Clinical trial authorisations
  137. 35Traditional herbal registrations
  138. 35AEarly Access to Medicines Scheme fees
  139. 36Online sellers of medicines
  140. Part 3: Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States
  141. 37Outgoing mutual recognition applications
  142. Part 4: Capital Fees for Applications for Variations of Authorisations, Licences and Registrations
  143. 38Marketing authorisations
  144. 39Variation of marketing authorisations
  145. 39AVariation of orphan marketing authorisations: small and medium companies
  146. 40Reclassification of marketing authorisations
  147. 40AFees where an application for a variation or an extension of a European Union marketing authorisation had been made before IP completion day
  148. 41Variation of marketing authorisation: national homoeopathic products
  149. 42Variation of parallel import licence
  150. 43Manufacturer's authorisations and licences
  151. 44Variation of manufacturer's authorisations and licences
  152. 45Wholesale dealer's licences
  153. 46Variation of wholesale dealer's licence
  154. 47Variation of a broker's registration
  155. 48Variation of an active substance registration
  156. 49Clinical trial authorisations
  157. 50Traditional herbal registrations
  158. 51Identical variations
  159. 52Complex Variation Applications
  160. 53Multiple reclassification variation applications
  161. Part 5: Capital Fees for Assessment of Labels and Leaflets
  162. 54A set of changes
  163. 55More than one set of changes proposed
  164. Part 6: Capital Fee for the Renewal of a Marketing Authorisation
  165. 56Renewal of a marketing authorisation
  166. 57Renewal of multiple marketing authorisations
  167. Part 6A: Capital Fee for Conducting a Major Safety Review
  168. 57AParagraph 57A
  169. Part 6B: Capital Fee for Testing of Samples by the Appropriate Authority
  170. 57BParagraph 57B
  171. Part 7: Relevant Substances
  172. 58Substances listed for the purposes of paragraph 24(2)(b) and (4)(b) and 38(2)(b)
  173. Schedule 3: Fees for inspections
  174. 1General provisions relating to fees for inspections
  175. 2Fees: general
  176. 3Traditional herbal medicinal products
  177. 4Sites concerned with starting materials for traditional herbal medicinal products
  178. 5Wholesale dealer's licence: general
  179. 6Wholesale dealer's licence: traditional herbal medicinal products
  180. 7Wholesale dealer's licences: inspection of short duration
  181. 8Broker's registrations
  182. 9Active substance registrations
  183. 10Office-based inspections
  184. Schedule 4: Periodic fees for licences
  185. Part 1: Interpretation
  186. 1Paragraph 1
  187. Part 2: Value of the Product Sold or Supplied
  188. 2Determining the total value of the product
  189. 3Manufacturer's prices
  190. 4Information requirements
  191. Part 3: Periodic Fees for Marketing Authorisations and Licences
  192. 5Marketing authorisations
  193. 6Marketing authorisation: where Part 2 of the Act applies
  194. 7Marketing authorisation: derivatives
  195. 8Number of fee periods
  196. 9Authorisation for two or more kinds of medicinal product
  197. 10Reduced fees
  198. 11Manufacturer's licences or manufacturing authorisations
  199. 12Wholesale dealer's licences
  200. 13Wholesale dealer's licences: evidence
  201. 14Wholesale dealer's licences: special medicinal products
  202. 15Additional amount for manufacturer's licences and wholesale dealer's licences which relate to special medicinal products
  203. 16Traditional herbal registrations
  204. 17Online sellers of medicines
  205. Part 4: Types of Marketing Authorisation for which only One Periodic Fee is Payable
  206. 18Parallel import licences
  207. Schedule 5Fees for certificates of registration
  208. Schedule 6: Time for payment of capital fees: small companies
  209. 1Interpretation
  210. 2Major application
  211. 3Complex application
  212. 4Multiple application
  213. 5Outgoing mutual recognition application
  214. 6Application for traditional herbal registration
  215. 7Traditional herbal registration: complex variation
  216. 8Application for manufacturer's licence, manufacturing authorisation or wholesale dealer's licence
  217. 9Inspection fees in connection with applications
  218. Schedule 7: Waiver, reduction or refund of capital fees
  219. 1Interruptions of manufacture, assembly, sale or supply
  220. 2Reclassification
  221. 3Variation of a traditional herbal registration
  222. 4Withdrawal of application in relation to marketing authorisation, traditional herbal registration or clinical trial authorisation
  223. 5Withdrawal of application in relation to a certificate of registration
  224. 6Withdrawal of application in relation to manufacturing authorisation, wholesale dealer's licence, manufacturer's licence, broker's registration or active substance registration
  225. 7Refusal of application for grant of marketing authorisation, traditional herbal registration or clinical trial authorisation
  226. 7AOrphan marketing authorisation
  227. 8Parallel import licence
  228. 9Surrender of marketing authorisation at same time as a variation application
  229. 10Clinical trial authorisation
  230. 11Scientific advice: paediatric indications
  231. 12Refunds: treated as having been paid on account
  232. Schedule 8: Adjustment , waiver reduction or refund of periodic fees
  233. 1Refund on surrender or revocation of authorisation, registration or licence
  234. 2Adjustment and refund: licences relating to imported special medicinal products
  235. 2AWaiver or refund: converted EU marketing authorisations
  236. 3Refunds: treated as having been paid on account
  237. Explanatory note