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S.I. No. 617/2006 - Irish Medicines Board (Fees) Regulations 2006

S.I. No. 617/2006 - Irish Medicines Board (Fees) Regulations 2006 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 2006 S.I. No. 617/2006 - Irish Medicines Board (Fees) Regulations 2006 S.I. No. 617/2006 - Irish Medicines Board (Fees) Regulations 2006 AmendmentsLeasuithe S.I. No. 617 of 2006 Irish Medicines Board (Fees) Regulations 2006 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 - “Board” means the Irish Medicines Board; “manufacturing licence” means a licence granted pursuant to the Medical Preparations (Licensing of Manufacture) Regulations 1993 to 1996; “product authorisation” means an authorisation granted pursuant to the Medical Preparations (Licensing and Sale) Regulations 1998 ( S.I. No. 142 of 1998 ); “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. SCHEDULE COLUMN 1 COLUMN 2 Fees for National Applications for Product Authorisations € National application - complex dossier, new active substance 11,149 Each additional form ( same time ) 4,643 Each additional strength (same time) 598 Additional drug master file submitted with any of the above 2,966 National application - reduced complex 8,368 Each additional form (same time) 4,643 Each additional strength (same time) 598 Additional drug master file submitted with any of the above 2,966 National application - reduced dossier standard 5,574 Each additional form (same time) 4,643 Each additional strength (same time) 598 Additional drug master file submitted with any of the above 2,966 Subsequent extension applications - first additional form 5,574 Each additional form (same time) 4,643 First additional strength ( existing form ) 2,514 Each additional strength ( same time ) 598 Fees for Applications for Product Authorisations using European Mutual Recognition procedure Mutual recognition incoming - complex dossier, new active substance 7,808 Each additional form (same time) 3,339 Each additional strength (same time) 598 Outgoing mutual recognition/decentralised supplement 10,000 Decentralised Outgoing/Incoming 11,149 Each additional form (same time) 4,643 Each additional strength (same time) 598 Mutual recognition incoming - reduced complex 5,947 Each additional form (same time) 2,966 Each additional strength (same time) 598 Outgoing mutual recognition / decentralised supplement 10,000 Decentralised Outgoing/Incoming 8,368 Each additional form (same time) 4,643 Each additional strength (same time) 598 Mutual recognition incoming - reduced dossier standard 3,898 Each additional form (same time) 2,608 Each additional strength (same time) 598 Outgoing mutual recognition / decentralised supplement 6,500 Decentralised Outgoing/Incoming 5,574 Each additional form (same time) 4,643 Each additional strength (same time) 598 Subsequent extension applications - mutual recognition incoming (first additional form) 2,608 - mutual recognition incoming (first additional strength) 1,760 - mutual recognition incoming (subsequent additional strength) 598 Outgoing mutual recognition/decentralised supplement (additional form) 2,608 Outgoing mutual recognition/decentralised supplement (additional strength) 598 Decentralised Outgoing / Incoming First Additional Form 5,574 Each additional form (same time) 4,643 First additional strength (existing form) 2,514 Each additional strength (same time) 598 Change of address for Product Authorisation holder: 1 to 20 Product Authorisations 108 Change of address for Product Authorisation holder: more than 20 Product Authorisations 539 Fees for Parallel Product Authorisations Application fee - per country at the same time or by variation 1,516 Each additional strength per country 452 Each additional form per country 452 Registration of parallel imports 515 Each additional strength or form 258 Fees for Variations to Product Authorisations that are nationally licensed Type IA variation 333 Type IA variation - reduced rate 167 Type IB variation 452 Type IB variation - reduced rate 226 Type II complex variation 2,966 Type II standard variation 577 Type II standard variation - reduced rate 288 Notifications made under Article 61

(3)of Directive 2001 / 83 / EC 452 Notifications made under Article 61
(3)of Directive 2001 / 83 / EC - reduced rate 226 Fees for Variations to Product Authorisations licensed under European Mutual Recognition procedure Type IA variation - outgoing mutual recognition / decentralised supplement 333 Type IA variation - mutual recognition incoming 333 Type IA variation - mutual recognition incoming - reduced rate 167 Type IB variation outgoing mutual recognition / decentralised supplement 385 Type IB variation - mutual recognition incoming 385 Type IB variation - mutual recognition incoming - reduced rate 199 Type II complex variation - outgoing mutual recognition / decentralised supplement 598 Type II complex variation - mutual recognition incoming 2,049 Type II standard variation - mutual recognition incoming 385 Type II standard variation - mutual recognition incoming - reduced rate 199 Type II standard variation - outgoing mutual recognition / decentralised supplement 385 Notifications made under Article 61
(3)of Directive 2001 / 83 / EC 452 Notifications made under Article 61
(3)of Directive 2001 / 83 / EC - reduced rate 226 Fees for the granting of a Product Authorisation on transfer to another company Change of ownership - related company - per form 1,025 Change of ownership - related company - per strength 293 Change of ownership - non-related company - per form 1,500 Change of ownership - non-related company - per strength 293 Other fees relating to the granting of Product Authorisations Service item 558 Fees for Wholesale Licences Application fee 506 Annual fee - large site 2,528 Annual fee - medium site 1,437 Annual fee - minor site 506 Variation to licence - administrative 200 Variation to licence - technical 550 Variation to licence - minor site 200 Fees for Manufacturing Licences Application fee 1,690 Annual fee - major site ( more than 250 employees ) 15,206 Annual fee - large site ( 150 - 250 employees ) 10,137 Annual fee - medium site ( 50 - 149 employees ) 6,759 Annual fee - small site ( less than 50 employees ) 3,378 Variation to licence - administrative 250 Variation to licence - technical 700 Fees for the granting of a Manufacturing Licence or a Wholesale Licence on transfer to another company Manufacture - related companies 1,010 Manufacture - unrelated companies 1,690 Wholesale - related companies 333 Wholesale - unrelated companies 506 Given under my Official Seal this 12th day of December 2006 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.) 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 . 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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