S.I. No. 731/2003 - Irish Medicines Board (Fees) Regulations, 2003 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.
- ie)Translations (Houses of the Oireachtas) Government Publications for Sale EU Law (EUR-Lex) FAQ Disclaimer Feedback Helpdesk Search Baile Reachtaíocht Achtanna an Oireachtais Ionstraimí Reachtúla Reachtaíocht Réamh-1922 Bunreacht Acmhainní Seachtracha Billí (Tithe an Oireachtais) Iris Oifigiúil Achtanna Athbhreithnithe (CAD) (An Coimisiún um Athchóiriú an Dlí) Liosta Rangaithe Reachtaíochta Aistriúcháin (achtanna.
- ie)Aistriúcháin (Tithe an Oireachtais) Foilseacháin Rialtais ar Díol Dlí AE (EUR-Lex) CCanna (Ceisteanna Coitianta) Séanadh Aiseolas Deasc chabhrach Cuardach TitleTeideal Year(
- s)or rangeBliain nó blianta nó raon TypeCineál All Legislation Acts Statutory Instruments Advanced SearchCuardach Casta HomeBaile Statutory InstrumentsIonstraimí Reachtúla 2003 S.I. No. 731/2003 - Irish Medicines Board (Fees) Regulations, 2003 S.I. No. 731/2003 - Irish Medicines Board (Fees) Regulations, 2003 AmendmentsLeasuithe I, Micheál Martin, 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, 2003. 2. These Regulations shall come into force on the 1st day of January 2004. 3. In these Regulations:- “the Act” means the Irish Medicines Board Act, 1995 ; “the Board” means the Irish Medicines Board; “manufacturing licence” means a licence granted pursuant to the Medical Preparations (Licensing of Manufacture) Regulations, 1993 - 1996. “wholesale licence” means a licence granted pursuant to the Medical Preparations (Wholesale Licences) Regulations 1993 - 1996. “product authorisation” means an authorisation granted pursuant to the Medical Preparations (Licensing and Sale) Regulations, 1998 ( S.I. No. 142 of 1998 ). “certificate of registration” means a certificate granted, in respect of homeopathic medicinal products, pursuant to the Medical Preparations (Licensing and Sale) Regulations, 1998 ( S.I. No. 142 of 1998 ). 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, product authorisations and certificates of registration, 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) (Medicinal Products for Human Use Regulations, 2002 ( S.I. No. 262 of 2002 ) are hereby revoked. SCHEDULE COLUMN 1 COLUMN 2 Euro Fees for National Applications for Product Authorisations National application — complex dossier, new active substance 10,056 Each additional form (same time) 4,188 Each additional strength (same time) 540 Additional drug master file submitted with any of the above 2,676 National application — reduced complex 7,548 Each additional form (same time) 4,188 Each additional strength (same time) 540 Additional drug master file submitted with any of the above 2,676 National application — reduced dossier standard 5,028 Each additional form (same time) 4,188 Each additional strength (same time) 540 Additional drug master file submitted with any of the above 2,676 Subsequent extension applications - first additional form 5,028 Each additional form (same time) 4,188 First additional strength (existing form) 2,268 Each additional strength (same time) 540 Fees for Applications for Product Authorisations using European Mutual Recognition procedure Mutual recognition incoming — complex dossier, new active substance 7,044 Each additional form (same time) 3,012 Each additional strength (same time) 540 Outgoing mutual recognition supplement 7,620 Mutual recognition incoming — reduced complex 5,364 Each additional form (same time) 2,676 Each additional strength (same time) 540 Outgoing mutual recognition supplement 7,620 Mutual recognition incoming — reduced dossier standard 3,516 Each additional form (same time) 2,352 Each additional strength (same time) 540 Outgoing mutual recognition supplement 4,572 Subsequent extension applications — mutual recognition incoming (additional form) 2,352 Mutual recognition incoming (additional strength) 540 Outgoing mutual recognition supplement (additional form) 2,352 Outgoing mutual recognition supplement (additional strength) 540 Fees for Parallel Product Authorisations Euro Application fee - per country at the same time or by variation 1,368 Each additional strength per country 408 Each additional form per country 408 Fees for Variations to Product Authorisations that are nationally licensed Type 1A variation 300 Type 1A variation — reduced rate 150 Type 1B variation 408 Type 1B variation — reduced rate 204 Type II complex variation 2,676 Type II standard variation 520 Type II standard variation — reduced rate 260 Notifications made under Article 61
(3)of Directive 2001 / 83 / EC 408 Fees for Variations to Product Authorisations licensed under European Mutual Recognition procedure Type 1A variation — outgoing mutual recognition supplement 300 Type 1A variation — mutual recognition incoming 300 Type 1A variation — mutual recognition incoming — reduced rate 150 Type 1B variation - outgoing mutual recognition supplement 348 Type 1B variation — mutual recognition incoming 348 Type 1B variation — mutual recognition incoming — reduced rate 180 Type II complex variation - outgoing mutual recognition supplement 540 Type II complex variation — mutual recognition incoming 1,848 Type II standard variation — mutual recognition incoming 348 Type II standard variation — mutual recognition incoming — reduced rate 180 Notifications made under Article 61
(3)of Directive 2001 / 83 / EC 408 Fees for the granting of a Product Authorisation on transfer to another company Change of ownership — related company - per form 924 Change of ownership - related company - per strength 264 Change of ownership — non-related company - per form 2,436 Change of ownership — non-related company - per strength 264 Change of ownership — non-related company - reduced rate 1,680 Other fees relating to the granting of Product Authorisations Euro Service item 504 Application for certificate of registration in respect of homeopathic medicinal products New application standard fee — single stock 600 New application standard fee — 2-5 stocks 800 New application standard fee — 6 or more stocks 1,000 New application stock already assessed — single stock 450 New application stock already assessed — 2-5 stocks 600 New application stock already assessed — 6 or more stocks 700 New application formulation already assessed — single stock 450 New application formulation already assessed — 2-5 stocks 600 New application formulation already assessed — 6 or more stocks 700 New application stock & formulation already assessed — single stock 350 New application stock & formulation already assessed — 2-5 stocks 450 New application stock & formulation already assessed — 6 or more stocks 500 Technical variation 330 Technical variation — reduced rate 165 Administrative variation 230 Administrative variation — reduced rate 115 Fees for Wholesale Licences Application fee 456 Annual fee - large site 2,280 Annual fee - medium site 1,296 Annual fee - minor site 456 Variation to licence - administrative 156 Variation to licence - technical 456 Variation to licence - minor site 156 Fees for Manufacturing Licences Application fee 1,524 Annual fee - major site (> 250 employees) 13,716 Annual fee - large site ( 150 — 250 employees) 9,144 Annual fee - medium site (50 - 149 employees) 6,096 Annual fee - small site ( < 50 employees) 3,048 Variation to licence — administrative 180 Variation to licence - technical 552 Fees for the granting of a Manufacturing Licence or a Wholesale Licence on transfer to another company Euro Manufacture — related companies 912 Manufacture — unrelated companies 1,524 Wholesale - related companies 300 Wholesale - unrelated companies 456 Given under the official seal of the Minister for Health and Children this 30th day of December, 2003. Micheál Martin ________________________ 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 payment of fees 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