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S.I. No. 882/2005 - Irish Medicines Board (Fees) Regulations 2005

S.I. No. 882/2005 - Irish Medicines Board (Fees) Regulations 2005 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 2005 S.I. No. 882/2005 - Irish Medicines Board (Fees) Regulations 2005 S.I. No. 882/2005 - Irish Medicines Board (Fees) Regulations 2005 AmendmentsLeasuithe S.I. No. 882 of 2005 Irish Medicines Board (Fees) Regulations 2005 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 2005. 2. These Regulations shall come into force on the 1st day of January 2006. 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 2004 ( S.I. No. 877 of 2004 ) are hereby revoked. SCHEDULE COLUMN 1 COLUMN 2 Fees for National Applications for Product Authorisations € National application - complex dossier, new active substance 10,824 Each additional form (same time) 4,508 Each additional strength (same time) 581 Additional drug master file submitted with any of the above 2,880 National application - reduced complex 8,124 Each additional form (same time) 4,508 Each additional strength (same time) 581 Additional drug master file submitted with any of the above 2,880 National application - reduced dossier standard 5,412 Each additional form (same time) 4,508 Each additional strength (same time) 581 Additional drug master file submitted with any of the above 2,880 Subsequent extension applications - first additional form 5,412 Each additional form (same time) 4,508 First additional strength (existing form) 2,441 Each additional strength (same time) 581 Fees for Applications for Product Authorisations using European Mutual Recognition procedure Mutual recognition incoming - complex dossier, new active substance 7,581 Each additional form (same time) 3,242 Each additional strength (same time) 581 Outgoing mutual recognition/decentralised supplement 8,202 Decentralised Outgoing/Incoming 10,824 Each additional form (same time) 4,508 Each additional strength (same time) 581 Mutual recognition incoming - reduced complex 5,774 Each additional form (same time) 2,880 Each additional strength (same time) 581 Outgoing mutual recognition / decentralised supplement 8,202 Decentralised Outgoing/Incoming 8,124 Each additional form (same time) 4,508 Each additional strength (same time) 581 Mutual recognition incoming - reduced dossier standard 3,784 Each additional form (same time) 2,532 Each additional strength (same time) 581 Outgoing mutual recognition / decentralised supplement 4,921 Decentralised Outgoing/Incoming 5,412 Each additional form (same time) 4,508 Each additional strength (same time) 581 Subsequent extention applications - mutual recognition incoming (first additional form) 2,532 - mutual recognition incoming (first additional strenght) 1,709 - mutual recognition incoming (subsequent additional strength) 581 Outgoing mutual recognition/decentralised supplement (additional form) 2,532 Outgoing mutual recognition/decentralised supplement ( additional strength ) 581 Decentralised Outgoing / Incoming First Additional Form 5,412 Each additional form ( same time ) 4,508 First additional strength ( existing form ) 2,441 Each additional strength ( same time ) 581 Change of address for Product Authorisation holder: 1 to 20 Product Authorisations 105 Change of address for Product Authorisation holder: more than 20 Product Authorisations 523 Fees for Parallel Product Authorisations Application fee - per country at the same time or by variation 1,472 Each additional strength per country 439 Each additional form per country 439 Registration of parallel imports 500 Each additional strength or form 250 Fees for Variations to Product Authorisations that are nationally licensed Type IA variation 323 Type IA variation - reduced rate 162 Type IB variation 439 Type IB variation - reduced rate 219 Type II complex variation 2,880 Type II standard variation 560 Type II standard variation - reduced rate 280 Notifications made under Article 61

(3)of Directive 2001 / 83 / EC 439 Notifications made under Article 61
(3)of Directive 2001 / 83 / EC - reduced rate 219 Fees for Variations to Product Authorisations licensed under European Mutual Recognition procedure Type IA variation - outgoing mutual recognition / decentralised supplement 323 Type IA variation - mutual recognition incoming 323 Type IA variation - mutual recognition incoming - reduced rate 162 Type IB variation outgoing mutual recognition / decentralised supplement 374 Type IB variation - mutual recognition incoming 374 Type IB variation - mutual recognition incoming - reduced rate 193 Type II complex variation - outgoing mutual recognition / decentralised supplement 581 Type II complex variation - mutual recognition incoming 1,989 Type II standard variation - mutual recognition incoming 374 Type II standard variation - mutual recognition incoming - reduced rate 193 Type II standard variation - outgoing mutual recognition / decentralised supplement 374 Notifications made under Article 61
(3)of Directive 2001 / 83 / EC 439 Notifications made under Article 61
(3)of Directive 2001 / 83 / EC - reduced rate 219 Fees for the granting of a Product Authorisation on transfer to another company Change of ownership - related company - per form 995 Change of ownership - related company - per strength 284 Change of ownership - non-related company - per form 2,622 Change of ownership - non-related company - per strength 284 Change of ownership - non-related company - reduced rate 1,808 Other fees relating to the granting of Product Authorisations Service item 542 Fees for Wholesale Licences Application fee 491 Annual fee - large site 2,454 Annual fee - medium site 1,395 Annual fee - minor site 491 Variation to licence - administrative 168 Variation to licence - technical 491 Variation to licence - minor site 168 Fees for Manufacturing Licences Application fee 1,641 Annual fee - major site (more than 250 employees) 14,763 Annual fee - large site ( 150 - 250 employees ) 9,842 Annual fee - medium site ( 50 - 149 employees ) 6,562 Annual fee - small site ( less than 50 employees ) 3,280 Variation to licence - administrative 193 Variation to licence - technical 595 Fees for the granting of a Manufacturing Licence or a Wholesale Licence on transfer to another company Manufacture - related companies 981 Manufacture - unrelated companies 1,641 Wholesale - related companies 323 Wholesale - unrelated companies 491 Given under my Official Seal this 23rd day of December 2005 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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