S.I. No. 524/2004 -- Irish Medicines Board (Fees) (Amendment) Regulations 2004
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STATUTORY INSTRUMENTS. |
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IRISH MEDICINES BOARD (FEES) (AMENDMENT) REGULATIONS 2004. |
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IRISH MEDICINES BOARD (FEES) (AMENDMENT) REGULATIONS 2004. |
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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 1955 (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: |
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“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. |
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SCHEDULE |
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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”) |
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EXPLANATORY NOTE. |
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(This note is not part of the Instrument and does not purport to be a legal interpretation.) |
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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 ). |
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