# The Medicines (Products for Human Use) (Fees) Regulations 2012 (revoked) S.I. 2012/504 · made 23 February 2012 · revised to 1 April 2013 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PDFs: Printed copy https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012-revoked/pdf/uksi_20120504_en.pdf; Explanatory Memorandum https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012-revoked/pdf/uksiem_20120504_en.pdf ## Introductory text Medicines Fees And Charges Made 23rd February 2012 Laid before Parliament 29th February 2012 Coming into force 1st April 2012 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 1: General ## 1 Citation and commencement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 2: Capital Fees for Pre-Application Meetings ## 3 Interpretation of Part 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Fee for scientific advice: application for, or variation to, EU marketing authorization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Fee for scientific advice: classification of a medicinal product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Fee for advertising advice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Fee for pharmacovigilance advice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Fee for advice on labelling or leaflets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Fee for regulatory advice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 Fee for advice for other purposes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 Time for payment of fees under regulations 4 to 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 3: Capital Fees for Applications for Authorizations, Registrations, Licences, Certificates or Authorisations and for Associated Inspections ## 12 Fees for applications for authorizations, licences or certificates etc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 13 Fee for applications for copy certificates of good manufacturing practice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 14 Fees for applications for certificates and copy certificates by exporters of medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 4: Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States ## 15 Meaning of “set of applications” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 16 Fees for applications for regulatory assistance under the mutual recognition procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 17 Time for payment of fees under regulation 16 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 5: Capital Fees for Applications for Variations of Authorizations, Registrations, Licences and Authorisations and for Associated Inspections ## 18 Fees for variations of authorizations, registrations, licences and authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 19 Fees for amendments to clinical trial authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 20 Applications for multiple variations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 6: Capital Fees for Assessment of Labels and Leaflets ## 21 Meaning of “set of proposed changes” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 22 Fees for assessment of a set of proposed changes to labels and leaflets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 23 Time for payment of fees under regulation 22 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 7: Capital Fees for Applications for Renewals of Certain Licences, Authorizations and Registrations and for Associated Inspections ## 24 Fees for renewals of certain manufacturer's licences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 25 Fees for renewals in terms which are not identical to the existing authorization, licence or registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 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 Authorizations ## 26 Fees for regulatory assistance for certain marketing authorizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 9: Capital Fees for Inspections ## 27 Fees for inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 28 Payer of inspection fee (contract laboratories and API manufacturing sites) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 29 Inspections in connection with multiple applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 30 Fees for inspections relating to good clinical practice in clinical trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 31 Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer's licence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 32 Adjustment and refund of inspection fees in respect of a wholesale dealer's licence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 10: Periodic Fees for Authorizations, Registrations, Licences and Authorisations ## 33 Periodic fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 34 Periodic fees for clinical trial authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 11: Capital Fees For Application For Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership ## 35 Meaning of “good clinical practice accreditation scheme” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 36 Fees for applications for membership and certificates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 12: Capital Fee for a Person Appointed Hearing ## 37 Fee for a person appointed hearing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 38 Time for payment under regulation 37 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 13: Fees in relation to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 ## 39 Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 40 Fees for applications made at the invitation of the licensing authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 41 Fees for applications for certificates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 42 Fees for variations of certificates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 43 Time for payment of fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 14: Administration ## 44 Payment of fees to Ministers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 45 Time for payment of capital fees in connection with applications or inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 46 Time for payment of capital fees – applications made by small companies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 47 Payment of fees in respect of a traditional herbal registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 48 Time for payment of periodic fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 49 Penalty fees for late payment of periodic fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 50 Daily penalty fees for late payment of periodic fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 51 Refund or waiver of fees under regulation 49 or 50 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 52 Adjustment, waiver, reduction or refund of fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 53 Suspension of licences and authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 54 Civil proceedings to recover unpaid fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 15: Consequential Amendments ## 55 Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 56 Amendment of the Homoeopathic Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Part 16: Revocations and Savings ## 57 The Medicines (Products for Human Use) (Fees) Regulations 2010 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 58 The Homoeopathic Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 1: INTERPRETATION ## 1 Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 2: CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES, AUTHORISATIONS, REGISTRATIONS AND CERTIFICATES ### Part 1: General: interpretation and categories of applications and variations ## 1 Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 General: categories of Applications and Variations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Administrative variation application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Extension application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Complex application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Complex registration application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Complex variation application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Decentralised procedure application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Extended Type II Complex Variation Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 Major application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 Mutual recognition procedure incoming application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 12 New excipient variation application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 13 New indication variation application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 14 Parallel Import Licence application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 15 Reclassification variation application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 16 Reduced registration application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 17 Simple application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 18 Standard application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 19 Standard registration application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 20 Standard variation application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 21 Standard variation application for a homoeopathic medicinal product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 22 Type IB and Type II Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 23 Type II Complex Variation Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 2: Capital Fees for Applications for Authorizations, Licences, Registrations and Certificates ## 24 Marketing authorizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 25 Fees where application includes reclassification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 26 Fees where person holds clinical trial certificate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 27 Joint development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 28 Application for multiple authorizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 29 Authorisation for a national homoeopathic product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 30 Manufacturer's licences and authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 31 Wholesale dealer's licences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 32 Clinical trial authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 33 Traditional herbal registrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 3: Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States ## 34 Outgoing mutual recognition applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 4: Capital Fees for Applications for Variations of Authorizations, Licences and Registrations ## 35 Marketing authorizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 36 Variation of marketing authorizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 37 Reclassification of marketing authorizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 38 Variation of marketing authorization: national homoeopathic products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 39 Variation of parallel import licence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 40 Manufacturer's authorisations and licences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 41 Variation of manufacturer's authorisations and licences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 42 Wholesale dealer's licences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 43 Variation of wholesale dealer's licence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 44 Clinical trial authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 45 Traditional herbal registrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 46 Identical variations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 47 Complex Variation Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 48 Multiple reclassification variation applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 5: Capital Fees for Assessment of Labels and Leaflets ## 49 A set of changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 50 More than one set of changes proposed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 6: 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 Authorizations ## 51 Regulatory assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 52 Regulatory assistance – same manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 3: FEES FOR INSPECTIONS ## 1 General provisions relating to fees for inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Fees: general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Traditional herbal medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Sites concerned with starting materials for traditional herbal medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Wholesale dealer's licence: general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Wholesale dealer's licence: traditional herbal medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Wholesale dealer's licences: inspection of short duration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Office-based inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 4: PERIODIC FEES FOR LICENCES ### Part 1: Interpretation ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 2: Value of the Product Sold or Supplied ## 2 Determining the total value of the product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Manufacturer's prices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Information requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 3: Periodic Fees for Marketing Authorizations and Licences ## 5 Marketing authorizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Marketing authorization: where Part 2 of the Act applies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Marketing authorization: derivatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Number of fee periods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Authorisation for two or more kinds of medicinal product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 Reduced fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 Manufacturer's licences or manufacturing authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 12 Wholesale dealer's licences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 13 Wholesale dealer's licences: evidence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 14 Wholesale dealer's licences: exempt imported products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 15 Additional amount for manufacturer's licences and wholesale dealer's licences which relate to exempt imported products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 16 Clinical trial authorisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 17 Traditional herbal registrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### Part 4: Types of Marketing Authorization for which only One Periodic Fee is Payable ## 18 Parallel import licences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 5 FEES FOR CERTIFICATES OF REGISTRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 6: TIME FOR PAYMENT OF CAPITAL FEES: SMALL COMPANIES ## 1 Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Major application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Complex application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Multiple application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Outgoing mutual recognition application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Application for traditional herbal registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Traditional herbal registration: complex variation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Application for manufacturer's licence, manufacturing authorisation or wholesale dealer's licence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Inspection fees in connection with applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 7: WAIVER, REDUCTION OR REFUND OF CAPITAL FEES ## 1 Interruptions of manufacture, assembly, sale or supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Reclassification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Variation of a traditional herbal registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 4 Withdrawal of application in relation to marketing authorization, traditional herbal registration or clinical trial authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 5 Withdrawal of application in relation to a certificate of registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Withdrawal of application in relation to manufacturing authorisation, wholesale dealer's licence or manufacturer's licence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Refusal of application for grant of marketing authorization, traditional herbal registration or clinical trial authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Parallel import licence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Surrender of marketing authorization at same time as a variation application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 Clinical trial authorisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 Scientific advice: paediatric indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 12 Refunds: treated as having been paid on account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Schedule 8: ADJUSTMENT, REDUCTION OR REFUND OF PERIODIC FEES ## 1 Refund on surrender or revocation of authorization, registration or licence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Adjustment and refund: licences relating to exempt imported products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Refunds: treated as having been paid on account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Explanatory note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . --- Source: https://www.legislation.gov.uk/uksi/2012/504 (the official version) Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012-revoked Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.