Source: http://www.legislation.gov.uk/uksi/2009/389/contents/made
Timestamp: 2013-05-24 11:54:17
Document Index: 246850331

Matched Legal Cases: ['ART 1', 'ART 2', 'art 24', 'ART 3', 'ART 4', 'ART 5', 'ART 6', 'ART 7', 'ART 8', 'ART 9', 'ART 10', 'ART 11', 'ART 12', 'ART 13', 'ART 14', 'ART 15', 'ART 1', 'ART 2', 'ART 3', 'ART 4', 'ART 5', 'ART 6', 'ART 1', 'ART 2', 'ART 3', 'ART 4']

The Medicines (Products for Human Use) (Fees) Regulations 2009
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Status:This is the original version (as it was originally made). UK Statutory Instruments are not carried in their revised form on this site.Introductory TextPART 1 1.Citation and commencement2.InterpretationPART 2 3.Interpretation of Part 24.Fee for scientific advice: application for or variation to EC marketing authorization5.Fee for scientific advice: classification of a medicinal product6.Fee for advertising advice7.Fee for pharmacovigilance advice8.Fee for advice on labelling or leaflets9.Fee for regulatory advice10.Fee for advice for other purposes11.Time for payment of fees under regulations 4 to 10PART 3 12.Fees for applications for authorizations, licences or certificates etc.13.Fee for applications for copy certificates of good manufacturing practice14.Fees for applications for certificates and copy certificates by exporters of medicinal productsPART 4 EEA15.Meaning of “set of applications”16.Fees for applications for regulatory assistance under the mutual recognition procedure17.Time for payment of fees under regulation 16PART 5 18.Fees for variations of authorizations, registrations, licences and authorisations19.Fees for amendments to clinical trial authorisations20.Applications for multiple variationsPART 6 21.Meaning of “set of proposed changes”22.Fees for assessment of a set of proposed changes to labels and leaflets23.Time for payment of fees under regulation 22PART 7 24.Fees for renewals of certain manufacturer’s licences25.Fees for renewals in terms which are not identical to the existing authorization, licence or certificatePART 8 26.Fees for regulatory assistance for certain marketing authorizationsPART 9 27.Fees for inspections28.Payer of inspection fee (contract laboratories and API manufacturing sites)29.Inspections in connection with multiple applications30.Fees for inspections relating to good clinical practice in clinical trials31.Amount of and time for payment of inspection fees in respect of an application for a wholesale dealer’s licence32.Adjustment and refund of inspection fees in respect of a wholesale dealer’s licencePART 10 33.Periodic fees34.Periodic fees for clinical trial authorisationsPART 11 35.Meaning of “good clinical practice accreditation” scheme36.Fees for applications for membership and certificatePART 12 37.Fee for a person appointed hearing38.Time for payment under regulation 37PART 13 39.Payment of fees to Ministers40.Time for payment of capital fees in connection with applications or inspections41.Time for payment of capital fees – applications made by small companies42.Payment of fees in respect of a traditional herbal registration43.Time for payment of periodic fees44.Penalty fees for late payment of periodic fees45.Daily penalty fees for late payment of periodic fees46.Refund or waiver of fees under regulation 44 or 4547.Adjustment, waiver, reduction or refund of fees48.Suspension of licences and authorisations49.Civil proceedings to recover unpaid feesPART 14 50.Amendment of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994PART 15 51.Revocations and savingsSignatureSCHEDULE 1CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES AND CERTIFICATESPART 1 General: Interpretation and categories of applications and variationsPART 2 Capital Fees for Applications for Authorizations, Licences, Registrations and CertificatesPART 3 Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA StatesPART 4 Capital Fees for Applications for Variations of Authorizations, Licences and RegistrationsPART 5 Capital Fees for Assessment of Labels and LeafletsPART 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 AuthorizationsSCHEDULE 2FEES FOR INSPECTIONSSCHEDULE 3PERIODIC FEES FOR LICENCESPART 1 InterpretationPART 2 Calculation of TurnoverPART 3 Periodic Fees for Marketing Authorizations and LicencesPART 4 Types of Marketing Authorization for which only One Periodic Fee is PayableSCHEDULE 4TIME FOR PAYMENT OF CAPITAL FEESSCHEDULE 5WAIVER, REDUCTION OR REFUND OF CAPITAL FEESSCHEDULE 6ADJUSTMENT, REDUCTION OR REFUND OF PERIODIC FEESSCHEDULE 7INTERPRETATIONExplanatory NoteBack to topOptions/HelpPrint OptionsPrint Table of ContentsPDF table of contentsWeb page table of contentsPrint The Whole InstrumentPDF The Whole InstrumentWeb page The Whole InstrumentLegislation is available in different versions:Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.Original (As Enacted or Made):The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.Opening OptionsDifferent options to open legislation in order to view more content on screen at onceExplanatory Memorandum