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 authorisation 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 Authorisations, Registrations, Licences or Certificates and for Associated Inspections Fees for applications for authorisations, registrations, licences or certificates etc. 12 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fee for applications for additional copy certificates 13 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fees for applications for certificates and copy certificates by exporters of medicinal products 14 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 4 Capital Fees for Assistance in Obtaining Marketing Authorisations 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 Authorisations, Registrations and Licences and for Associated Compliance Activities Fees for variations of authorisations, registrations and licences 18 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fees for amendments to clinical trial authorisations 19 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fees for notification of changes and reports for broker's registrations 20 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fees for notification of changes and compliance Reports for active substance registrations 21 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Applications for multiple variations 22 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 6 Capital Fees for Assessment of Labels and Leaflets Meaning of “set of proposed changes” 23 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fees for assessment of a set of proposed changes to labels and leaflets 24 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Time for payment of fees under regulation 24 25 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 7 Capital Fees for Applications for Renewals of Certain Licences, Authorisations and Registrations and for Associated Inspections Fees for renewals of certain manufacturer's licences 26 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fees for renewals in terms which are not identical to the existing authorisation, licence or registration 27 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 Fees for regulatory assistance for certain marketing authorisations 28 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 9 Capital Fees for Inspections Fees for inspections 29 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fees for inspections of pharmacovigilance service providers 30 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Payer of inspection fee (contract laboratories and API manufacturing sites) 31 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Inspections in connection with multiple applications 32 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fees for inspections relating to good clinical practice in clinical trials 33 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer's licence 34 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Adjustment and refund of inspection fees in respect of a wholesale dealer's licence 35 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Amount, and time for payment, of inspection fees in respect of an application for a broker's registration or an active substance registration 36 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 10 Periodic Fees for Authorisations, Registrations and Licences Periodic fees 37 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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” 38 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fees for applications for membership and certificates 39 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 12 Capital Fee for a Review Upon Oral Representations or a Person Appointed Hearing Fee for a review upon oral representations or a person appointed hearing 40 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Time for payment under regulation 40 41 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 13 Fees in relation to the Part 6 of the Human Medicines Regulations (certification of homoeopathic medicinal products) Interpretation 42 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fees for applications made at the invitation of the licensing authority 43 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fees for applications for certificates 44 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fees for variations of certificates 45 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Time for payment of fees 46 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 14 Administration Payment of fees to Ministers 47 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Time for payment of capital fees in connection with applications or inspections 48 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Time for payment of capital fees – applications made by small companies 49 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Payment of fees in respect of a traditional herbal registration 50 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Time for payment of periodic fees 51 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Penalty fees for late payment of periodic fees 52 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Daily penalty fees for late payment of periodic fees 53 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Refund or waiver of fees under regulation 52 or 53 54 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Adjustment, waiver, reduction or refund of fees 55 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Suspension of licences and authorisations 56 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Civil proceedings to recover unpaid fees 57 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 15 Consequential Amendments Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004 58 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PART 16 Revocations and Savings The Medicines (Products for Human Use) (Fees) Regulations 2012 59 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2012 60 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other Revocations 61 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .