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S.I. No. 44 of 1996.
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IRISH MEDICINES BOARD (FEES) REGULATIONS, 1996.
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In exercise of the powers conferred on the Minister for Health
Section 13
of the
Irish Medicines Board Act, 1995
(No. 29 of 1995), which said powers are delegated to me by the Health (Delegation of Ministerial Functions) Order, 1996 (
S.I. No. 24 of 1996
), I, BRIAN O'SHEA, Minister of State at the Department of Health, hereby make the following Regulations:—
1. These Regulations may be cited as the Irish Medicines Board (Fees) Regulations, 1995.
2. In these Regulations—
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"the Act" means the
Irish Medicines Board Act, 1995
.
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"the Board" means the Irish Medicines Board,
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"manufacturing licence" means a licence granted pursuant to the Medical Preparations (Licensing of Manufacture) Regulations, 1993—1996,
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"the Minister" means the Minister for Health,
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"product authorisation" means an authorisation granted pursuant to the Medical Preparations (Licensing and Sale) Regulations, 1996,
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"wholesale licence" means a licence granted pursuant to the Medical Preparations (Wholesale Licences) Regulations 1993-1996.
3. Subject to Article 4 hereof, there shall be paid to the Board in respect of each and every matter set out in column 1 of the schedule hereto the fee as set out in column 2 of the said Schedule.
4. The Board may, in circumstances where it considers it appropriate to do so, waive, remit or refund, either in whole or in part, any fee that would otherwise be payable to it under Article 3 hereof.
5. These Regulations shall come into operation on the 19th day of February, 1996.
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SCHEDULE
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COLUMN 1
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COLUMN 2
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Application for Product Authorisation
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£
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Full Dossier — Complex
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National application
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6,000.00
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Each additional form (at same time)
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2,500.00
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Each additional strength (at same time)
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320.00
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Incoming decentralised
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4,200.00
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Each addition form (at same time)
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1,800.00
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Each additional strength (at same time)
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320.00
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Outgoing decentralised supplement
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2,500.00
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Reduced Dossier — Complex
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National application
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4,500.00
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Each additional form (at same time)
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2,500.00
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Each additional strength (at same time)
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320.00
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Incoming decentralised
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3,200.00
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Each additional form (at same time)
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1,600.00
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Each additional strength (at same time)
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320.00
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Outgoing decentralised supplement
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2,500.00
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Reduced Dossier — Standard
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National application
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3,000.00
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Each additional form (at same time)
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2,500.00
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Each additional strength (at same time)
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320.00
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Incoming decentralised
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2,100.00
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Each additional form (at same time)
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1,400.00
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Each additional strength (at same time)
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320.00
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Outgoing decentralised supplement
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1,500.00
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Subsequent extension applications
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First additional form
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3,000.00
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Each additional form (at same time)
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2,500.00
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First additional strength (existing form)
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1,350.00
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Each additional strength (at same time)
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320.00
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Outgoing decentralised supplement
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—additional form
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1,400.00
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—additional strength
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320.00
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Variation of product authorisation
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Simple variation
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—national
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240.00
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—outgoing decentralised supplement
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210.00
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Complex variation
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—national
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1,600.00
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—outgoing decentralised supplement
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325.00
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Change of ownership
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—related company
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550.00
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—non-related company
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1,450.00
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Maintenance of product authorisation
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First strength in each form
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— annual fee
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290.00
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each additional strength
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— annual fee
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75.00
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Homoeopathic Registration
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Application
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360.00
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Wholesale Licence
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Annual Fee
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—Main site
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850.00
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—each additional site
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350.00
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—minor site
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250.00
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Variation to licence
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—administrative
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80.00
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—technical
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240.00
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Manufacturing Licence
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Annual fee
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—Major site (>250 employees)
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4,500.00
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—Large site (150—250 employees)
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3,000.00
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—Medium site (50—149 employees)
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2,000.00
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—small site (
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1,000.00
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Variation to licence
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—administrative
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80.00
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—technical
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240.00
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DATED this 13th day of February, 1996.
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BRIAN O'SHEA,
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Minister of State at the Department of Health.
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EXPLANATORY NOTE.
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The purpose of these Regulations is to provide for the payment of fees to the Irish Medicines Board pursuant to
section 13
of the
Irish Medicines Board Act, 1995
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