F1PART 1General

Annotations:
Amendments (Textual)

Citation and commencementF11

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InterpretationF12

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F1PART 2Capital Fees for Pre-Application Meetings

Interpretation of Part 2F13

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Fee for scientific advice: application for, or variation to, EU marketing authorisationF14

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Fee for scientific advice: classification of a medicinal productF15

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Fee for advertising adviceF16

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Fee for pharmacovigilance adviceF17

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Fee for advice on labelling or leafletsF18

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Fee for regulatory adviceF19

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Fee for advice for other purposesF110

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Time for payment of fees under regulations 4 to 10F111

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F1PART 3Capital Fees for Applications for Authorisations, Registrations, Licences or Certificates and for Associated Inspections

Fees for applications for authorisations, registrations, licences or certificates etc.F112

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Fee for applications for additional copy certificatesF113

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Fees for applications for certificates and copy certificates by exporters of medicinal productsF114

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F1PART 4Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States

Meaning of “set of applications”F115

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Fees for applications for regulatory assistance under the mutual recognition procedureF116

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Time for payment of fees under regulation 16F117

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F1PART 5Capital Fees for Applications for Variations of Authorisations, Registrations and Licences and for Associated Compliance Activities

Fees for variations of authorisations, registrations and licencesF118

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Fees for amendments to clinical trial authorisationsF119

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Fees for notification of changes and reports for broker's registrationsF120

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Fees for notification of changes and compliance Reports for active substance registrationsF121

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Applications for multiple variationsF122

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F1PART 6Capital Fees for Assessment of Labels and Leaflets

Meaning of “set of proposed changes”F123

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Fees for assessment of a set of proposed changes to labels and leafletsF124

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Time for payment of fees under regulation 24F125

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F1PART 7Capital Fees for Applications for Renewals of Certain Licences, Authorisations and Registrations and for Associated Inspections

Fees for renewals of certain manufacturer's licencesF126

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Fees for renewals in terms which are not identical to the existing authorisation, licence or registrationF127

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F1PART 8Capital 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 authorisationsF128

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F1PART 9Capital Fees for Inspections

Fees for inspectionsF129

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Fees for inspections of pharmacovigilance service providersF130

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Payer of inspection fee (contract laboratories and API manufacturing sites)F131

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Inspections in connection with multiple applicationsF132

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Fees for inspections relating to good clinical practice in clinical trialsF133

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Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer's licenceF134

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Adjustment and refund of inspection fees in respect of a wholesale dealer's licenceF135

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Amount, and time for payment, of inspection fees in respect of an application for a broker's registration or an active substance registrationF136

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F1PART 10Periodic Fees for Authorisations, Registrations and Licences

Periodic feesF137

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F1PART 11Capital Fees for Application for Membership of Good Clinical Practice Accreditation Scheme and for Certificate of Membership

Meaning of “good clinical practice accreditation scheme”F138

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Fees for applications for membership and certificatesF139

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F1PART 12Capital Fee for a Review Upon Oral Representations or a Person Appointed Hearing

Fee for a review upon oral representations or a person appointed hearingF140

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Time for payment under regulation 40F141

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F1PART 13Fees in relation to the Part 6 of the Human Medicines Regulations (certification of homoeopathic medicinal products)

InterpretationF142

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Fees for applications made at the invitation of the licensing authorityF143

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Fees for applications for certificatesF144

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Fees for variations of certificatesF145

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Time for payment of feesF146

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F1PART 14Administration

Payment of fees to MinistersF147

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Time for payment of capital fees in connection with applications or inspectionsF148

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Time for payment of capital fees – applications made by small companiesF149

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Payment of fees in respect of a traditional herbal registrationF150

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Time for payment of periodic feesF151

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Penalty fees for late payment of periodic feesF152

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Daily penalty fees for late payment of periodic feesF153

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Refund or waiver of fees under regulation 52 or 53F154

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Adjustment, waiver, reduction or refund of feesF155

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Suspension of licences and authorisationsF156

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Civil proceedings to recover unpaid feesF157

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F1PART 15Consequential Amendments

Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004F158

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F1PART 16Revocations and Savings

The Medicines (Products for Human Use) (Fees) Regulations 2012F159

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The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2012F160

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Other RevocationsF161

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