Medicines PART 1 General Citation and commencement 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Interpretation 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 2 Capital Fees for Pre-Application Meetings Interpretation of Part 2 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fee for scientific advice: application for, or variation to, EU marketing authorization 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fee for scientific advice: classification of a medicinal product 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fee for advertising advice 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fee for pharmacovigilance advice 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fee for advice on labelling or leaflets 8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fee for regulatory advice 9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fee for advice for other purposes 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Time for payment of fees under regulations 4 to 10 11 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 3 Capital Fees for Applications for Authorizations, Registrations, Licences, Certificates or Authorisations and for Associated Inspections Fees for applications for authorizations, licences or certificates etc. 12 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fee for applications for copy certificates of good manufacturing practice 13 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fees for applications for certificates and copy certificates by exporters of medicinal products 14 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 4 Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States Meaning of “set of applications” 15 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fees for applications for regulatory assistance under the mutual recognition procedure 16 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Time for payment of fees under regulation 16 17 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 5 Capital Fees for Applications for Variations of Authorizations, Registrations, Licences and Authorisations and for Associated Inspections Fees for variations of authorizations, registrations, licences and authorisations 18 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fees for amendments to clinical trial authorisations 19 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Applications for multiple variations 20 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 6 Capital Fees for Assessment of Labels and Leaflets Meaning of “set of proposed changes” 21 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fees for assessment of a set of proposed changes to labels and leaflets 22 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Time for payment of fees under regulation 22 23 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 7 Capital Fees for Applications for Renewals of Certain Licences, Authorizations and Registrations and for Associated Inspections Fees for renewals of certain manufacturer's licences 24 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fees for renewals in terms which are not identical to the existing authorization, licence or registration 25 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 Fees for regulatory assistance for certain marketing authorizations 26 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 9 Capital Fees for Inspections Fees for inspections 27 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Payer of inspection fee (contract laboratories and API manufacturing sites) 28 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Inspections in connection with multiple applications 29 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fees for inspections relating to good clinical practice in clinical trials 30 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer's licence 31 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Adjustment and refund of inspection fees in respect of a wholesale dealer's licence 32 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 10 Periodic Fees for Authorizations, Registrations, Licences and Authorisations Periodic fees 33 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Periodic fees for clinical trial authorisations 34 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 11 Capital Fees For Application For Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership Meaning of “good clinical practice accreditation scheme” 35 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fees for applications for membership and certificates 36 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 12 Capital Fee for a Person Appointed Hearing Fee for a person appointed hearing 37 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Time for payment under regulation 37 38 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 13 Administration Payment of fees to Ministers 39 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Time for payment of capital fees in connection with applications or inspections 40 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Time for payment of capital fees – applications made by small companies 41 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Payment of fees in respect of a traditional herbal registration 42 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Time for payment of periodic fees 43 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Penalty fees for late payment of periodic fees 44 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Daily penalty fees for late payment of periodic fees 45 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Refund or waiver of fees under regulation 44 or 45 46 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Adjustment, waiver, reduction or refund of fees 47 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Suspension of licences and authorisations 48 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Civil proceedings to recover unpaid fees 49 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 14 Amendment of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 50 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 15 Consequential Amendments Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004 51 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 16 Revocations and Savings Revocations and savings 52 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .