← Ireland

S.I. No. 542/2008 - Irish Medicines Board (Fees) Regulations 2008

S.I. No. 542/2008 - Irish Medicines Board (Fees) Regulations 2008 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.

  1. 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.
  2. ie)Aistriúcháin (Tithe an Oireachtais) Foilseacháin Rialtais ar Díol Dlí AE (EUR-Lex) CCanna (Ceisteanna Coitianta) Séanadh Aiseolas Deasc chabhrach Cuardach TitleTeideal Year(
  3. s)or rangeBliain nó blianta nó raon TypeCineál All Legislation Acts Statutory Instruments Advanced SearchCuardach Casta HomeBaile Statutory InstrumentsIonstraimí Reachtúla 2008 S.I. No. 542/2008 - Irish Medicines Board (Fees) Regulations 2008 S.I. No. 542/2008 - Irish Medicines Board (Fees) Regulations 2008 AmendmentsLeasuithe Download PDF Íoslódáil PDF S.I. No. 542 of 2008 IRISH MEDICINES BOARD (FEES) REGULATIONS 2008 Notice of the making of this Statutory Instrument was published in “Iris Oifigiúil” of 19th December, 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 2008. 2. These Regulations shall come into force on the 1st day of January 2009. 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. 866 of 2007 ) are hereby revoked. SCHEDULE COLUMN 1 COLUMN 2 Fees for National Applications for Product Authorisations € National application — complex dossier, new active substance 15,211 Each additional form (same time) 5,090 Each additional strength (same time) 656 Additional drug master file submitted with any of the above 3,251 National application — reduced complex 11,329 Each additional form (same time) 5,090 Each additional strength (same time) 656 Additional drug master file submitted with any of the above 3,251 National application — reduced dossier standard 7,658 Each additional form (same time) 5,090 Each additional strength (same time) 656 Additional drug master file submitted with any of the above 3,251 Subsequent extension applications — first additional form 7,658 Each additional form (same time) 5,090 First additional strength (existing form) 2,756 Each additional strength (same time) 656 Additional drug master file submitted with any of the above 3,251 Fees for Applications for Product Authorisations using European Mutual Recognition procedure Mutual recognition incoming — complex dossier, new active substance 10,647 Each additional form (same time) 3,660 Each additional strength (same time) 656 Outgoing mutual recognition/decentralised supplement 10,962 Decentralised Outgoing/Incoming 15,211 Each additional form (same time) 5,090 Each additional strength (same time) 656 Additional supplement DCP outgoing greater than 10 countries 5,000 Mutual recognition incoming — reduced complex 8,077 Each additional form (same time) 3,251 Each additional strength (same time) 656 Outgoing mutual recognition / decentralised supplement 10,962 Decentralised Outgoing/Incoming 11,329 Each additional form (same time) 5,090 Each additional strength (same time) 656 Additional supplement DCP outgoing greater than 10 countries 5,000 Mutual recognition incoming — reduced dossier standard 5,350 Each additional form (same time) 2,859 Each additional strength (same time) 656 Outgoing mutual recognition / decentralised supplement 7,126 Decentralised Outgoing/Incoming 7,658 Each additional form (same time) 5,090 Each additional strength (same time) 656 Additional supplement DCP outgoing greater than 10 countries 5,000 Subsequent extension applications — mutual recognition incoming (first additional form) 5,350 — mutual recognition incoming (first additional strength) 1,929 — mutual recognition incoming (subsequent additional strength) 656 Outgoing mutual recognition/decentralised supplement (additional form) 2,859 Outgoing mutual recognition/decentralised supplement (additional strength) 656 Decentralised Outgoing / Incoming First Additional Form 7,658 Each additional form (same time) 5,090 First additional strength (existing form) 2,756 Each additional strength (same time) 656 Additional supplement DCP outgoing greater than 10 countries 5,000 Change of address for Product Authorisation holder: 1 to 20 Product Authorisations 119 Change of address for Product Authorisation holder: more than 20 Product Authorisations 591 Fees for Parallel Product Authorisations Application fee — per country at the same time or by variation 1,662 Each additional strength per country 495 Each additional form per country 495 Dual pack registration of parallel imports 564 Each additional strength or form 283 Change of Ownership 525 Fees for Variations to Product Authorisations that are nationally licensed Type IA variation 365 Type IA variation — reduced rate 184 Type IB variation 495 Type IB variation — reduced rate 248 Type II complex variation 3,251 Type II standard variation 633 Type II standard variation — reduced rate 316 Notifications made under Article 61

(3)of Directive 2001 / 83 / EC 495 Notifications made under Article 61
(3)of Directive 2001 / 83 / EC— reduced rate 248 Bulk variation to multiple changes to the SPC (per product range) 8,000 Bulk variation for multiple changes to the same document 6,000 Introduction of standard statements from PHV working party — 1 to 5licences 1,500 Introduction of standard statements from PHV working party — 6 to 10 licences 3,000 Introduction of standard statements from PHV working party — 11 to 20 licences 6,000 Introduction of standard statements from PHV working party — 21 to 40 licences 12,000 Introduction of standard statements from PHV working party — 41 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 365 Type IA variation — mutual recognition incoming 315 Type IA variation — mutual recognition incoming — reduced rate 184 Type IB variation outgoing mutual recognition / decentralised supplement 365 Type IB variation — mutual recognition incoming 422 Type IB variation — mutual recognition incoming — reduced rate 218 Type II complex variation — outgoing mutual recognition / decentralised supplement 656 Type II complex variation — mutual recognition incoming 2,246 Type II standard variation — mutual recognition incoming 422 Type II standard variation — mutual recognition incoming — reduced rate 218 Type II standard variation — outgoing mutual recognition / decentralised supplement 422 Notifications made under Article 61
(3)of Directive 2001 / 83 / EC 495 Notifications made under Article 61
(3)of Directive 2001 / 83 / EC— reduced rate 248 Fees for the granting of a Product Authorisation on transfer to another company Change of ownership — related company — per form 1,123 Change of ownership — related company — per strength 321 Change of ownership — non-related company — per form 1,645 Change of ownership — non-related company — per strength 321 Other fees relating to the granting of Product Authorisations Service item 612 Fees for Wholesale Licences Application fee 555 Annual fee — large site 2,771 Annual fee — medium site 1,576 Annual fee — minor site 555 Variation to licence — administrative 219 Variation to licence — technical 603 Fees for Manufacturing Licences Application fee 1,853 Annual fee — major site (more than 250 employees) 16,669 Annual fee — large site (150 — 250 employees) 11,112 Annual fee — medium site (50 — 149 employees) 7,409 Annual fee — small site (less than 50 employees) 3,703 Variation to licence — administrative 274 Variation to licence — technical 768 Fees for Blood and Tissue Establishments Application fee 1,853 Annual fee — major site (more than 250 employees) 16,669 Annual fee — large site (150 — 250 employees) 11,112 Annual fee — medium site (50 — 149 employees) 7,409 Annual fee — small site (less than 50 employees) 3,703 Variation to licence — administrative 274 Variation to licence — technical 768 Fees for Laboratory Approvals Application fee 555 Annual fee — minor site 555 Variation to licence — administrative 219 Variation to licence — technical 603 Fees for the granting of a Manufacturing Licence or a Wholesale Licence on transfer to another company Manufacture — related companies 1,107 Manufacture — unrelated companies 1,853 Wholesale — related companies 365 Wholesale — unrelated companies 555 Fees for Notifications of Exempt Medicinal Products Per notification 2 Cap on total notifications 10,000 Fees for Medical Devices Certificates of free sale Certificates of free sale issued within 2 days (4 certs per request) 147 Certificates of free sale issued within 1 day (4 certs per request) 277 Additional certificates (available at the time of the initial request) 23 Registration of Devices Registration of In-vitro Diagnostic medical device 153 First registration of a general medical device 153 Re-registration of items currently on the market 153 Changes to registration thereafter 153 Electronic registration 131 Annual Verification Fee — up to 5 employees 153 Annual Verification Fee — between 6-20 employees 384 Annual Verification Fee — between 21-100 employees 768 Annual Verification Fee — Over 100 employees 1,645 Clinical Investigations Clinical Investigations — active implantable medical devices 3,837 Clinical Investigations — Class III and class IIb medical devices 3,837 Clinical Investigations — Class IIa and class I medical device 1,645 Clinical Investigations — Technical amendment to a previously approved clinical investigation 1,129 Clinical Investigations — Administrative amendment to a previously approved clinical investigation 219 Audits / Inspections Audits/ Inspections (including Notified Body) per day 1,489 Audits/Inspections (including Notified Body) per hour 234 Classifications Classification of a product (1 product per request) 250 Classification of additional products (available at the time of the initial request) 200 Appeal of a classification decision 250 Designation Fee for a Notified Body Designation Fee 3,672 Extension to the scope (per extension) 1,836 Medicinal Product/Medical Device — Drug Consultation fees New active substance 41,960 Established active in new therapeutic area 33,568 Established active and therapeutic area 29,372 Variations — Minor 839 Variations — Major 3,776 GIVEN under my Official Seal , 15 December 2008 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

🔗 To official source

AI explanation based on the official legal text. Indicative, not a substitute for legal advice.