S.I. No. 617/2006 - Irish Medicines Board (Fees) Regulations 2006
2006
617
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S.I. No. 617 of 2006
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Irish Medicines Board (Fees) Regulations 2006
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I, Mary Harney, 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) Regulations 2006.
2. These Regulations shall come into force on the 1st day of January 2007.
3. In these Regulations -
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-�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 to 1996;
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-�product authorisation-� means an authorisation granted pursuant to the Medical Preparations (Licensing and Sale) Regulations 1998 (S.I. No. 142 of 1998 );
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-�wholesale licence-� means a licence granted pursuant to the Medical Preparations (Wholesale Licences) Regulations 1993 to 1996.
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 and product authorisations in respect of medicinal products for human use.
5. Subject to Regulation 6 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.
6. 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 Regulation 5 hereof.
7. The Irish Medicines Board (Fees) Regulations 2005 ( S.I. No. 882 of 2005 ) are hereby revoked.
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SCHEDULE
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COLUMN 1
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COLUMN 2
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Fees for National Applications for Product Authorisations
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€
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National application - complex dossier, new active substance
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11,149
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Each additional form ( same time )
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4,643
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Each additional strength (same time)
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598
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Additional drug master file submitted with any of the above
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2,966
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National application - reduced complex
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8,368
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Each additional form (same time)
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4,643
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Each additional strength (same time)
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598
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Additional drug master file submitted with any of the above
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2,966
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National application - reduced dossier standard
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5,574
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Each additional form (same time)
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4,643
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Each additional strength (same time)
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598
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Additional drug master file submitted with any of the above
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2,966
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Subsequent extension applications - first additional form
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5,574
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Each additional form (same time)
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4,643
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First additional strength ( existing form )
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2,514
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Each additional strength ( same time )
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598
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Fees for Applications for Product Authorisations using European Mutual Recognition procedure
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Mutual recognition incoming - complex dossier, new active substance
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7,808
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Each additional form (same time)
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3,339
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Each additional strength (same time)
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598
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Outgoing mutual recognition/decentralised supplement
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10,000
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Decentralised Outgoing/Incoming
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11,149
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Each additional form (same time)
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4,643
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Each additional strength (same time)
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598
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Mutual recognition incoming - reduced complex
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5,947
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Each additional form (same time)
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2,966
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Each additional strength (same time)
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598
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Outgoing mutual recognition / decentralised supplement
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10,000
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Decentralised Outgoing/Incoming
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8,368
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Each additional form (same time)
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4,643
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Each additional strength (same time)
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598
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Mutual recognition incoming - reduced dossier standard
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3,898
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Each additional form (same time)
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2,608
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Each additional strength (same time)
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598
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Outgoing mutual recognition / decentralised supplement
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6,500
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Decentralised Outgoing/Incoming
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5,574
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Each additional form (same time)
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4,643
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Each additional strength (same time)
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598
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Subsequent extension applications
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- mutual recognition incoming (first additional form)
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2,608
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- mutual recognition incoming (first additional strength)
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1,760
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- mutual recognition incoming (subsequent additional strength)
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598
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Outgoing mutual recognition/decentralised supplement (additional form)
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2,608
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Outgoing mutual recognition/decentralised supplement
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(additional strength)
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598
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Decentralised Outgoing / Incoming First Additional Form
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5,574
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Each additional form (same time)
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4,643
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First additional strength (existing form)
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2,514
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Each additional strength (same time)
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598
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Change of address for Product Authorisation holder: 1 to 20
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Product Authorisations
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108
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Change of address for Product Authorisation holder: more than
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20 Product Authorisations
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539
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Fees for Parallel Product Authorisations
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Application fee - per country at the same time or by variation
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1,516
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Each additional strength per country
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452
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Each additional form per country
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452
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Registration of parallel imports
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515
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Each additional strength or form
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258
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Fees for Variations to Product Authorisations that are nationally licensed
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Type IA variation
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333
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Type IA variation - reduced rate
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167
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Type IB variation
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452
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Type IB variation - reduced rate
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226
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Type II complex variation
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2,966
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Type II standard variation
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577
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Type II standard variation - reduced rate
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288
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Notifications made under Article 61 (3) of Directive 2001 / 83 / EC
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452
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Notifications made under Article 61 (3) of Directive 2001 / 83 / EC - reduced rate
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226
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Fees for Variations to Product Authorisations licensed under European Mutual Recognition procedure
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Type IA variation - outgoing mutual recognition / decentralised supplement
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333
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Type IA variation - mutual recognition incoming
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333
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Type IA variation - mutual recognition incoming - reduced rate
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167
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Type IB variation outgoing mutual recognition / decentralised supplement
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385
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Type IB variation - mutual recognition incoming
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385
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Type IB variation - mutual recognition incoming - reduced rate
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199
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Type II complex variation - outgoing mutual recognition / decentralised supplement
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598
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Type II complex variation - mutual recognition incoming
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2,049
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Type II standard variation - mutual recognition incoming
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385
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Type II standard variation - mutual recognition incoming - reduced rate
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199
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Type II standard variation - outgoing mutual recognition / decentralised supplement
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385
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Notifications made under Article 61 (3) of Directive 2001 / 83 / EC
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452
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Notifications made under Article 61 (3) of Directive 2001 / 83 / EC - reduced rate
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226
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Fees for the granting of a Product Authorisation on transfer to another company
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Change of ownership - related company - per form
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1,025
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Change of ownership - related company - per strength
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293
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Change of ownership - non-related company - per form
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1,500
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Change of ownership - non-related company - per strength
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293
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Other fees relating to the granting of Product Authorisations
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Fees for Wholesale Licences
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Application fee
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506
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Annual fee - large site
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2,528
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Annual fee - medium site
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1,437
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Annual fee - minor site
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506
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Variation to licence - administrative
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200
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Variation to licence - technical
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550
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Variation to licence - minor site
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200
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Fees for Manufacturing Licences
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Application fee
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1,690
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Annual fee - major site ( more than 250 employees )
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15,206
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Annual fee - large site ( 150 - 250 employees )
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10,137
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Annual fee - medium site ( 50 - 149 employees )
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6,759
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Annual fee - small site ( less than 50 employees )
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3,378
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Variation to licence - administrative
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250
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Variation to licence - technical
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700
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Fees for the granting of a Manufacturing Licence or a Wholesale Licence on transfer to another company
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Manufacture - related companies
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1,010
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Manufacture - unrelated companies
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1,690
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Wholesale - related companies
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333
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Wholesale - unrelated companies
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506
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Given under my Official Seal this 12th day of December 2006
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Mary Harney
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________________
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Minister for Health and Children
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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 instrument.)
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The purpose of these Regulations is to provide for the revision of fees payable to the Irish Medicines Board pursuant to Section 13 of the Irish Medicines Board Act 1995 .
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