F1SCHEDULE 1CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES, AUTHORISATIONS, REGISTRATIONS AND CERTIFICATES
F1PART 1General: interpretation and categories of applications and variations
InterpretationF11
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General: categories of Applications and VariationsF12
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Administrative variation applicationF13
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Extension applicationF14
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Complex applicationF15
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Complex registration applicationF16
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Complex variation applicationF17
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Decentralised procedure applicationF18
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Extended Type II Complex Variation ApplicationF19
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Major applicationF110
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Mutual recognition procedure incoming applicationF111
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New excipient variation applicationF112
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New indication variation applicationF113
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Parallel Import Licence applicationF114
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Reclassification variation applicationF115
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Reduced registration applicationF116
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Simple applicationF117
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Standard applicationF118
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Standard registration applicationF119
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Standard variation applicationF120
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Standard variation application for a homoeopathic medicinal productF121
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Type IB and Type II ApplicationsF122
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Type II Complex Variation ApplicationF123
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F1PART 2Capital Fees for Applications for Authorizations, Licences, Registrations and Certificates
Marketing authorizationsF124
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Fees where application includes reclassificationF125
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Fees where person holds clinical trial certificateF126
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Joint developmentF127
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Application for multiple authorizationsF128
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Authorisation for a national homoeopathic productF129
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Manufacturer's licences and authorisationsF130
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Wholesale dealer's licencesF131
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Clinical trial authorisationsF132
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Traditional herbal registrationsF133
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F1PART 3Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States
Outgoing mutual recognition applicationsF134
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F1PART 4Capital Fees for Applications for Variations of Authorizations, Licences and Registrations
Marketing authorizationsF135
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Variation of marketing authorizationsF136
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Reclassification of marketing authorizationsF137
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Variation of marketing authorization: national homoeopathic productsF138
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Variation of parallel import licenceF139
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Manufacturer's authorisations and licencesF140
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Variation of manufacturer's authorisations and licencesF141
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Wholesale dealer's licencesF142
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Variation of wholesale dealer's licenceF143
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Clinical trial authorisationsF144
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Traditional herbal registrationsF145
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Identical variationsF146
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Complex Variation ApplicationsF147
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Multiple reclassification variation applicationsF148
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F1PART 5Capital Fees for Assessment of Labels and Leaflets
A set of changesF149
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More than one set of charges proposedF150
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F1PART 6Capital 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
Regulatory assistanceF151
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Regulatory assistance – same manufacturerF152
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F1SCHEDULE 2FEES FOR INSPECTIONS
General provisions relating to fees for inspectionsF11
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Fees: generalF12
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Traditional herbal medicinal productsF13
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Sites concerned with starting materials for traditional herbal medicinal productsF14
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Wholesale dealer's licence: generalF15
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Wholesale dealer's licence: traditional herbal medicinal productsF16
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Wholesale dealer's licences: inspection of short durationF17
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Office-based inspectionsF18
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F1SCHEDULE 3PERIODIC FEES FOR LICENCES
F1PART 1Interpretation
F11
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F1PART 2Calculation of Turnover
Calculation of turnoverF12
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Manufacturer's pricesF13
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Evidence of turnoverF14
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F1PART 3Periodic Fees for Marketing Authorizations and Licences
Marketing authorizationsF15
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Marketing authorization: where Part 2 of the Act appliesF16
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Marketing authorization: derivativesF17
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Number of fee periodsF18
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Authorisation for two or more kinds of medicinal productF19
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Reduced feesF110
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Manufacturer's licences or manufacturing authorisationsF111
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Wholesale dealer's licencesF112
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Wholesale dealer's licences: evidenceF113
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Wholesale dealer's licences: exempt imported productsF114
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Additional amount for manufacturer's licences and wholesale dealer's licences which relate to exempt imported productsF115
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Clinical trial authorisationsF116
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Traditional herbal registrationsF117
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F1PART 4Types of Marketing Authorization for which only One Periodic Fee is Payable
Specified parallel import licencesF118
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F1SCHEDULE 4TIME FOR PAYMENT OF CAPITAL FEES
InterpretationF11
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Major applicationF12
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Complex applicationF13
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Multiple applicationF14
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Outgoing mutual recognition applicationF15
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Application for traditional herbal registrationF16
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Traditional herbal registration: complex variationF17
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Application for manufacturer's licence, manufacturing authorisation or wholesale dealer's licenceF18
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Inspection fees in connection with applicationsF19
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F1SCHEDULE 5WAIVER, REDUCTION OR REFUND OF CAPITAL FEES
Interruptions of manufacture, assembly, sale or supplyF11
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ReclassificationF12
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Variation of a traditional herbal registrationF13
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Withdrawal of application in relation to marketing authorization, traditional herbal registration or clinical trial authorisationF14
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Withdrawal of application in relation to manufacturing authorisation, wholesale dealer's licence or manufacturer's licenceF15
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Refusal of application for grant of marketing authorization, traditional herbal registration or clinical trial authorisationF16
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Parallel import licenceF17
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Surrender of marketing authorization at same time as a variation applicationF18
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Clinical trial authorisationF19
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Scientific advice: paediatric indicationsF110
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F1SCHEDULE 6ADJUSTMENT, REDUCTION OR REFUND OF PERIODIC FEES
Refund on surrender or revocation of authorization, registration or licenceF11
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Adjustment and refund: licences relating to exempt imported productsF12
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Refunds: treated as having been paid on accountF13
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F1SCHEDULE 7INTERPRETATION
InterpretationF11
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F12
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F13
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Regulations revoked (1.4.2012) by The Medicines (Products for Human Use) (Fees) Regulations 2012 (S.I. 2012/504), regs. 1, 57(1) (with reg. 57(2)-(4)) and Regulations expressed to be revoked (N.I.) (1.4.2012) by The Medicines (Products for Human Use) (Fees) Regulations 2012 (S.R. 2012/134), regs. 1, 57 (with reg. 57(2)-(4))