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S.I. No. 866/2007 - Irish Medicines Board (Fees) Regulations 2007

S.I. No. 866/2007 - Irish Medicines Board (Fees) Regulations 2007 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 2007 S.I. No. 866/2007 - Irish Medicines Board (Fees) Regulations 2007 S.I. No. 866/2007 - Irish Medicines Board (Fees) Regulations 2007 AmendmentsLeasuithe Download PDF Íoslódáil PDF S.I. No. 866 of 2007 IRISH MEDICINES BOARD (FEES) REGULATIONS 2007 Notice of the making of this Statutory Instrument was published in “Iris Oifigiúil” of 25th January, 2008. 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 2007. 2. These Regulations shall come into force on the 1st day of January 2008. 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 2007 ( S.I. No.617 of 2006 ) are hereby revoked. SCHEDULE COLUMN 1 COLUMN 2 Fees for National Applications for Product Authorisations € National application — complex dossier, new active substance 14,500 Each additional form (same time) 4,852 Each additional strength (same time) 625 Additional drug master file submitted with any of the above 3,099 National application — reduced complex 10,800 Each additional form (same time) 4,852 Each additional strength (same time) 625 Additional drug master file submitted with any of the above 3,099 National application — reduced dossier standard 7,300 Each additional form (same time) 4,852 Each additional strength (same time) 625 Additional drug master file submitted with any of the above 3,099 Subsequent extension applications — first additional form 7,300 Each additional form (same time) 4,852 First additional strength (existing form) 2,627 Each additional strength (same time) 625 Fees for Applications for Product Authorisations using European Mutual Recognition procedure € Mutual recognition incoming — complex dossier, new active substance 10,150 Each additional form (same time) 3,489 Each additional strength (same time) 625 Outgoing mutual recognition/decentralised supplement 10,450 Decentralised Outgoing/Incoming 14,500 Each additional form (same time) 4,852 Each additional strength (same time) 625 Mutual recognition incoming — reduced complex 7,700 Each additional form (same time) 3,099 Each additional strength (same time) 625 Outgoing mutual recognition / decentralised supplement 10,450 Decentralised Outgoing/Incoming 10,800 Each additional form (same time) 4,852 Each additional strength (same time) 625 Mutual recognition incoming — reduced dossier standard 5,100 Each additional form (same time) 2,725 Each additional strength (same time) 625 Outgoing mutual recognition / decentralised supplement 6,793 Decentralised Outgoing/Incoming 7,300 Each additional form (same time) 4,852 Each additional strength (same time) 625 Subsequent extension applications — mutual recognition incoming (first additional form) 5,100 — mutual recognition incoming (first additional strength) 1,839 — mutual recognition incoming (subsequent additional strength) 625 Outgoing mutual recognition/decentralised supplement (additional form) 2,725 Outgoing mutual recognition/decentralised supplement (additional strength) 625 Decentralised Outgoing / Incoming First Additional Form 7,300 Each additional form (same time) 4,852 First additional strength (existing form) 2,627 Each additional strength (same time) 625 Change of address for Product Authorisation holder: 1 to 20 Product Authorisations 113 Change of address for Product Authorisation holder: more than 20 Product Authorisations 563 Fees for Parallel Product Authorisations € Application fee — per country at the same time or by variation 1,584 Each additional strength per country 472 Each additional form per country 472 Dual pack registration of parallel imports 538 Each additional strength or form 270 Change of Ownership 500 Fees for Variations to Product Authorisations that are nationally licensed € Type IA variation 348 Type IA variation — reduced rate 175 Type IB variation 472 Type IB variation — reduced rate 236 Type II complex variation 3,099 Type II standard variation 603 Type II standard variation — reduced rate 301 Notifications made under Article 61

(3)of Directive 2001 / 83 / EC 472 Notifications made under Article 61
(3)of Directive 2001 / 83 / EC—reduced rate 236 Bulk variation to multiple changes to the SPC (per product range) 8,000 Introduction of standard statements from PHV working party — 0 to 50 licences 15,000 Introduction of standard statements from PHV working party — 51 to 100 licences 20,000 Introduction of standard statements from PHV working party — 101 and above 30,000 Fees for Variations to Product Authorisations licensed under European Mutual Recognition procedure € Type IA variation — outgoing mutual recognition / decentralised supplement 348 Type IA variation — mutual recognition incoming 300 Type IA variation — mutual recognition incoming — reduced rate 175 Type IB variation outgoing mutual recognition / decentralised supplement 348 Type IB variation — mutual recognition incoming 402 Type IB variation — mutual recognition incoming — reduced rate 208 Type II complex variation — outgoing mutual recognition / decentralised supplement 625 Type II complex variation — mutual recognition incoming 2,141 Type II standard variation — mutual recognition incoming 402 Type II standard variation — mutual recognition incoming — reduced rate 208 Type II standard variation — outgoing mutual recognition / decentralised supplement 402 Notifications made under Article 61
(3)of Directive 2001 / 83 / EC 472 Notifications made under Article 61
(3)of Directive 2001 / 83 / EC—reduced rate 236 Fees for the granting of a Product Authorisation on transfer to another company € Change of ownership — related company — per form 1,071 Change of ownership — related company — per strength 306 Change of ownership — non-related company — per form 1,568 Change of ownership — non-related company — per strength 306 Other fees relating to the granting of Product Authorisations € Service item 583 Fees for Wholesale Licences € Application fee 529 Annual fee — large site 2,642 Annual fee — medium site 1,502 Annual fee — minor site 529 Variation to licence — administrative 209 Variation to licence — technical 575 Fees for Manufacturing Licences € Application fee 1,766 Annual fee — major site (more than 250 employees) 15,890 Annual fee — large site (150 — 250 employees) 10,593 Annual fee — medium site (50 — 149 employees) 7,063 Annual fee — small site (less than 50 employees) 3,530 Variation to licence — administrative 261 Variation to licence — technical 732 Fees for the granting of a Manufacturing Licence or a Wholesale Licence on transfer to another company € Manufacture — related companies 1,055 Manufacture — unrelated companies 1,766 Wholesale — related companies 348 Wholesale — unrelated companies 529 Fees for Notifications of Exempt Medicinal Products € 1-50 Notifications (per notification) 6 51-500 Notifications (per notification) 5 501-1,000 Notifications (per notification) 4 1,001-5,000 Notifications (per notification) 3 5,001-20,000 Notifications (per notification) 2 20,001 and above Notifications (per notification) 1 Fees for Medical Devices € Certificates of free sale Certificates of free sale issued within 2 days (4 certs per request) 140 Certificates of free sale issued within 1 day (4 certs per request) 264 Additional certificates (available at the time of the initial request) 22 Registration of Devices € Registration of In-vitro Diagnostic medical device 146 First registration of a general medical device 146 Re-registration of items currently on the market 146 Changes to registration thereafter 146 Electronic registration 125 Annual Verification Fee — up to 5 employees 146 Annual Verification Fee — between 6-20 employees 366 Annual Verification Fee — between 21-100 employees 732 Annual Verification Fee — Over 100 employees 1,568 Clinical Investigations € Clinical Investigations — active implatable medical devices 3,658 Clinical Investigations — Class III and class IIb medical devices 3,658 Clinical Investigations — Class IIa and class I medical device 1,568 Clinical Investigations — Amendment to a previously approved clinical Investigation 1,076 Audits / Inspections € Audits/ Inspections (including Notified Body) per day 1,419 Audits/Inspections (including Notified Body) per hour 223 Classifications € Classification of a product (1 product per request) 209 Classification of additional products (available at the time of the intial request) 157 Appeal of a classification decision 209 Designation Fee for a Notified Body € Designation Fee 3,500 Extension to the scope (per extension) 1,750 Medicinal Product/Medical Device — Drug Consultation fees € New active substance 40,000 Established active in new therapeutic area 32,000 Established active and therapeutic area 28,000 Variations — Minor 800 Variations — Major 3,600 GIVEN under my Official Seal, 21 December 2007 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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