S.I. No. 877/2004 - Irish Medicines Board (Fees) Regulations 2004

S.I. No. 877/2004 - Irish Medicines Board (Fees) Regulations 2004 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 2004 S.I. No. 877/2004 - Irish Medicines Board (Fees) Regulations 2004 S.I. No. 877/2004 - Irish Medicines Board (Fees) Regulations 2004 AmendmentsLeasuithe 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 2004. 2. These Regulations shall come into force on the 1st day of January 2005. 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 2003 ( S.I. No. 731 of 2003 ) and the Irish Medicines Board (Fees) (Amendment) Regulations 2004 ( S.I. No. 524 of 2004 ) are hereby revoked. SCHEDULE COLUMN 1 COLUMN 2 Fees for National Applications for Product Authorisations € National application - complex dossier, new active substance 10,358 Each additional form (same time) 4,314 Each additional strength (same time) 556 Additional drug master file submitted with any of the above 2,756 National application - reduced complex 7,774 Each additional form (same time) 4,314 Each additional strength (same time) 556 Additional drug master file submitted with any of the above 2,756 National application - reduced dossier standard 5,179 Each additional form (same time) 4,314 Each additional strength (same time) 556 Additional drug master file submitted with any of the above 2,756 Subsequent extension applications - first additional form 5,179 Each additional form (same time) 4,314 First additional strength (existing form) 2,336 Each additional strength (same time) 556 Fees for Applications for Product Authorisations using European Mutual Recognition procedure Mutual recognition incoming - complex dossier, new active substance 7,255 Each additional form (same time) 3,102 Each additional strength (same time) 556 Outgoing mutual recognition supplement 7,849 Mutual recognition incoming - reduced complex 5,525 Each additional form (same time) 2,756 Each additional strength (same time) 556 Outgoing mutual recognition supplement 7,849 Mutual recognition incoming - reduced dossier standard 3,621 Each additional form (same time) 2,423 Each additional strength (same time) 556 Outgoing mutual recognition supplement 4,709 Subsequent extension application - mutual recognition incoming (first additional form) 2,423 - mutual recognition incoming (first additional strength) 1,635 - mutual recognition incoming (subsequent additional strength) 556 Outgoing mutual recognition supplement (additional form) 2,423 Outgoing mutual recognition supplement (additional strength) 556 Change of address for Product Authorisation holder: 1 to 20 Product Authorisations 100 Change of address for Product Authorisation holder: more than 20 Product Authorisations 500 Fees for Parallel Product Authorisations Application fee - per country at the same time or by variation 1,409 Each additional strength per country 420 Each additional form per country 420 Fees for Variations to Product Authorisations that are nationally licensed Type IA variation 309 Type IA variation - reduced rate 155 Type IB variation 420 Type IB variation - reduced rate 210 Type II complex variation 2,756 Type II standard variation 536 Type II standard variation - reduced rate 268 Notifications made under Article 61