The Medicines (Products for Human Use) (Fees) Regulations 2013 (revoked)

Contents

Part 1 · General

1Citation and commencement#

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2Interpretation#

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Part 2 · Capital Fees for Pre-Application Meetings

3Interpretation of Part 2#

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4Fee for scientific advice: application for, or variation to, EU marketing authorisation#

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5Fee for scientific advice: classification of a medicinal product#

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6Fee for advertising advice#

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7Fee for pharmacovigilance advice#

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8Fee for advice on labelling or leaflets#

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9Fee for regulatory advice#

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10Fee for advice for other purposes#

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11Time for payment of fees under regulations 4 to 10#

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

12Fees for applications for authorisations, registrations, licences or certificates etc.#

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13Fee for applications for additional copy certificates#

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14Fees for applications for certificates and copy certificates by exporters of medicinal products#

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

15Meaning of “set of applications”#

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16Fees for applications for regulatory assistance under the mutual recognition procedure#

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17Time for payment of fees under regulation 16#

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

18Fees for variations of authorisations, registrations and licences#

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19Fees for amendments to clinical trial authorisations#

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20Fees for notification of changes and reports for broker's registrations#

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21Fees for notification of changes and compliance Reports for active substance registrations#

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22Applications for multiple variations#

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Part 6 · Capital Fees for Assessment of Labels and Leaflets

23Meaning of “set of proposed changes”#

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24Fees for assessment of a set of proposed changes to labels and leaflets#

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25Time for payment of fees under regulation 24#

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

26Fees for renewals of certain manufacturer's licences#

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27Fees for renewals in terms which are not identical to the existing authorisation, licence or registration#

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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

28Fees for regulatory assistance for certain marketing authorisations#

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Part 9 · Capital Fees for Inspections

29Fees for inspections#

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30Fees for inspections of pharmacovigilance service providers#

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31Payer of inspection fee (contract laboratories and API manufacturing sites)#

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32Inspections in connection with multiple applications#

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33Fees for inspections relating to good clinical practice in clinical trials#

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34Amount, and time for payment, of inspection fees in respect of an application for a wholesale dealer's licence#

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35Adjustment and refund of inspection fees in respect of a wholesale dealer's licence#

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36Amount, and time for payment, of inspection fees in respect of an application for a broker's registration or an active substance registration#

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Part 10 · Periodic Fees for Authorisations, Registrations and Licences

37Periodic fees#

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

38Meaning of “good clinical practice accreditation scheme”#

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39Fees for applications for membership and certificates#

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

40Fee for a review upon oral representations or a person appointed hearing#

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41Time for payment under regulation 40#

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

42Interpretation#

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43Fees for applications made at the invitation of the licensing authority#

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44Fees for applications for certificates#

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45Fees for variations of certificates#

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46Time for payment of fees#

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Part 14 · Administration

47Payment of fees to Ministers#

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48Time for payment of capital fees in connection with applications or inspections#

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49Time for payment of capital fees – applications made by small companies#

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50Payment of fees in respect of a traditional herbal registration#

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51Time for payment of periodic fees#

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52Penalty fees for late payment of periodic fees#

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53Daily penalty fees for late payment of periodic fees#

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54Refund or waiver of fees under regulation 52 or 53#

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55Adjustment, waiver, reduction or refund of fees#

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56Suspension of licences and authorisations#

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57Civil proceedings to recover unpaid fees#

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Part 15 · Consequential Amendments

58Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004#

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Part 16 · Revocations and Savings

59The Medicines (Products for Human Use) (Fees) Regulations 2012#

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60The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2012#

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61Other Revocations#

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Schedule 1 · General interpretation provisions

(1). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(3). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

Schedule 2 · Capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates

Part 1 · General: interpretation and categories of applications and variations

(1). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(2). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(3). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(4). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(5). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(6). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(7). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(8). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(9). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(10). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(11). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(12). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(13). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(14). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(15). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(16). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(17). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(18). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(19). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(20). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(21). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(22). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(23). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

Part 2 · Capital Fees for Applications for Authorisations, Licences, Registrations and Certificates

(24). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(25). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(26). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(27). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(28). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(29). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(30). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(31). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(32). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(33). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(34). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(35). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

Part 3 · Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States

(36). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

Part 4 · Capital Fees for Applications for Variations of Authorisations, Licences and Registrations

(37). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(38). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(39). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(40). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(41). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(42). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(43). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(44). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(45). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(46). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(47). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(48). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(49). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(50). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(51). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(52). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

Part 5 · Capital Fees for Assessment of Labels and Leaflets

(53). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(54). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

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 Authorisations

(55). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

(56). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

Part 7 · Relevant Substances

(57). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (repealed)

Schedule 3 · Fees for inspections