S.I. No. 878/2004 - European Communities (Clinical Trials on Medicinal Products For Human Use) (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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- s)or rangeBliain nó blianta nó raon TypeCineál All Legislation Acts Statutory Instruments Advanced SearchCuardach Casta HomeBaile Statutory InstrumentsIonstraimí Reachtúla 2004 S.I. No. 878/2004 - European Communities (Clinical Trials on Medicinal Products For Human Use) (Amendment) Regulations 2004 S.I. No. 878/2004 - European Communities (Clinical Trials on Medicinal Products For Human Use) (Amendment) Regulations 2004 AmendmentsLeasuithe I, Mary Harney, Minister for Health and Children, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) and for the purpose of giving further effect to Directive 2001/20/EC1 of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, hereby make the following regulations: 1. These Regulations may be cited as the European Communities (Clinical Trials on Medicinal Products for Human Use) (Amendment) Regulations 2004. 2. In these Regulations “Principal Regulations” mean the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 ( S.I. No. 190 of 2004 ). 3. Regulation 12
(3)of the Principal Regulations is hereby amended by the substitution for sub-paragraph (
- a)of the following sub-paragraph — “(
- a)for — (
- i)the whole State, or (
- ii)that part of the State in which the chief investigator is professionally based; and” 4. Regulation 52
(1)of the Principal Regulations is hereby substituted by the following paragraph — “
(1)The fees that shall be payable to the Board in connection with — (
- i)any request for authorisation made to or accepted by the Board under Regulation 14, 15, 16 or 17, or (
- ii)any notice of amendment sent to the Board under Regulation 21, or (iii) any application made to or granted by the Board under Regulation 35 or 41, shall be as determined by the Board with the approval of the Minister. GIVEN under my Official Seal this 22nd day of December 2004. Mary Harney ___________ Minister for Health and Children Explanatory Note (This note is not part of the instrument and does not purport to be a legal instrument.) These Regulations make provision for the payment of charges for services provided by the Irish Medicines Board in respect of clinical trials conducted under the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 ( S.I. No. 190 of 2004 ). The charges are determined by the Irish Medicines Board subject to the approval of the Minister for Health and Children. 1 OJ L. 121, 01.05.2001, p.34. 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