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S.I. No. 524/2004 - Irish Medicines Board (Fees) (Amendment) Regulations 2004

S.I. No. 524/2004 - Irish Medicines Board (Fees) (Amendment) Regulations 2004 Skip to content Disclaimer Feedback Helpdesk Gaeilge Léim go dtí an t-ábhar Séanadh Aiseolas Deasc chabhrach English Gaeilge English Produced by the Office of the Attorney General Táirgthe ag Oifig an Ard-Aighne Home Legislation Acts of the Oireachtas Statutory Instruments Pre-1922 Legislation Constitution External Resources Bills (Houses of the Oireachtas) Iris Oifigiúil / Official Gazette Revised Acts (LRC) Classified List of Legislation (LRC) Translations (acts.

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  3. s)or rangeBliain nó blianta nó raon TypeCineál All Legislation Acts Statutory Instruments Advanced SearchCuardach Casta HomeBaile Statutory InstrumentsIonstraimí Reachtúla 2004 S.I. No. 524/2004 - Irish Medicines Board (Fees) (Amendment) Regulations 2004 S.I. No. 524/2004 - Irish Medicines Board (Fees) (Amendment) Regulations 2004 AmendmentsLeasuithe STATUTORY INSTRUMENTS. S.I. No. 524 of 2004 . IRISH MEDICINES BOARD (FEES) (AMENDMENT) REGULATIONS 2004. S.I. No. 524 of 2004 . IRISH MEDICINES BOARD (FEES) (AMENDMENT) REGULATIONS 2004. I, MICHEÁL MARTIN, Minister for Health and Children, in exercise of the powers conferred on me by sections 13 and 32 of the Irish Medicines Board Act 1995 (No. 29 of 1995), as adapted by the Health (Alteration of Name of Department and Title of Minister) Order 1997 ( S.I. No. 308 of 1997 ) and of all other powers enabling me in that behalf, hereby make the following regulations: 1. These Regulations may be cited as the Irish Medicines Board (Fees) (Amendment) Regulations 2004. 2. In these Regulations “Principal Regulations” means the Irish Medicines Board (Fees) Regulations 2003 ( S.I. No. 731 of 2003 ). 3. The Principal Regulations and these Regulations may be cited together as the Irish Medicines Board (Fees) Regulations 2003 and 2004 and shall be construed together as one. 4. The Principal Regulations are amended by substituting the following Regulation for Regulation 4: “4. These Regulations shall apply to the fees that may be charged by the Board, in pursuit of its statutory duties, in relation to applications for the grant or renewal of manufacturing licences, wholesale licences, product authorisations and certificates of registration, in respect of medicinal products for human use, and in relation to its duties and functions under the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 ( S.I. No. 190 of 2004 ). 5. The Schedule to the Principal Regulations is amended by inserting after the entry headed “Fees for the granting of a Manufacturing Licence or a Wholesale Licence on transfer to another company” the entries specified in the Schedule to these Regulations. SCHEDULE Fees for Requests for Authorisation to Conduct a Clinical Trial under the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 (hereafter in this Schedule referred to as the “Clinical Trial Regulations”) Requests for authorisation under Regulation 14 of the Clinical Trial Regu-lations (not being a request to which Regulation 16 applies) Phase IV Trials (
  4. a)Investigational medicinal product to be used within the terms of its marketing authorisation €228 (
  5. b)Investigational medicinal product to be used otherwise than in accordance with the terms of its marketing auth-orisation €456 Phase I, II or III Trials (
  6. a)Investigational medicinal product containing an established active substance €456 (
  7. b)Investigational medicinal product containing a new active substance €1,224 (
  8. c)Notice of Amendment under Regulation 21 of Clinical Trial Regulations €72 Request for authorisation under Regulation 14 of Clinical Trial Regulations (being a request to which Regulation 16 applies) Phase IV Trials (
  9. a)Investigational medicinal product to be used within the terms of its marketing authorisation €456 (
  10. b)Investigational medicinal product to be used otherwise than in accordance with the terms of its marketing auth-orisation €912 Phase I, II or III Trials (
  11. a)Investigational medicinal product containing an established active substance €912 (
  12. b)Investigational medicinal product containing a new active substance €2,448 (
  13. c)Notice of Amendment under Regulation 21 of Clinical Trial Regulations €144 Fee for Application for manufacturing authorisation under Regulation 35 of Clinical Trial Regulations Application for manufacturing authorisation under Regulation 35 of Clinical Trial Regulations 1,524 GIVEN under my Official Seal, this 31st day of August, 2004. MICHEÁL MARTIN, Minister for Health and Children. EXPLANATORY NOTE. (This note is not part of the Instrument and does not purport to be a legal interpretation.) These Regulations amend the Irish Medicines Board (Fees) Regulations 2003 ( S.I. No. 731 of 2003 ) to make provision for fees payable to the Irish Medicines Board in respect of requests for authorisation and other applications under the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 ( S.I. No. 190 of 2004 ). Privacy Statement Accessibility European Legislation Identifier (PDF) Open Data License Ráiteas Príobháideachais Inrochtaineacht Aitheantóir Eorpach Reachtaíochta (ELI) Ceadúnas Sonraí Oscailte Liosta Fianán © Government of Ireland. Oireachtas Copyright Material is reproduced with the permission of the Houses of the Oireachtas © Rialtas na hÉireann. Atáirgtear ábhar faoi Chóipcheart le cead ó Thithe an Oireachtais

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