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Statutory InstrumentNot in force

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

Citation
S.I. 2013/532
As at
Sections
172
Section 1Citation and commencement

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Section 2Interpretation

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Section 3Interpretation of Part 2

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

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

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Section 6Fee for advertising advice

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Section 7Fee for pharmacovigilance advice

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Section 8Fee for advice on labelling or leaflets

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Section 9Fee for regulatory advice

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Section 10Fee for advice for other purposes

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

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

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Section 13Fee for applications for additional copy certificates

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

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Section 15Meaning of “set of applications”

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

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Section 17Time for payment of fees under regulation 16

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Section 18Fees for variations of authorisations, registrations and licences

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Section 19Fees for amendments to clinical trial authorisations

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

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

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Section 22Applications for multiple variations

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Section 23Meaning of “set of proposed changes”

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

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Section 25Time for payment of fees under regulation 24

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Section 26Fees for renewals of certain manufacturer's licences

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

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Section 28Fees for regulatory assistance for certain marketing authorisations

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Section 29Fees for inspections

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Section 30Fees for inspections of pharmacovigilance service providers

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

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Section 32Inspections in connection with multiple applications

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

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

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

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Section 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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Section 37Periodic fees

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Section 38Meaning of “good clinical practice accreditation scheme”

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Section 39Fees for applications for membership and certificates

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

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Section 41Time for payment under regulation 40

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Section 42Interpretation

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

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Section 44Fees for applications for certificates

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Section 45Fees for variations of certificates

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Section 46Time for payment of fees

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Section 47Payment of fees to Ministers

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

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

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

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172 sections

Cite this legislation

The Medicines (Products for Human Use) (Fees) Regulations 2013 (revoked) (legislation.gov.uk, OGL v3.0). Retrieved via LawPlayer, https://lawplayer.com/uk/act/uksi-2013-532

Contains public sector information licensed under the Open Government Licence v3.0.

OGL-3

本頁資料來源:legislation.gov.uk (The National Archives)·整理提供:法律人 LawPlayer· lawplayer.com