S.I. No. 684/2011 - Irish Medicines Board (Fees) Regulations 2011.

(1)In these Regulations— “Act” means the Irish Medicines Board Act 1995 (No. 29 of 1995), as amended by s. 197 of the Finance Act 1999 (No. 2 of 1999), by Regulation 3 of the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 ( S.I. No. 304 of 2001 ), by Regulation 2 of the European Communities (Medical Devices) (Amendment) Regulations 2001 (S.I. 444 of 2001), by Regulation 3 of the European Communities (Medical Devices) (Amendment) Regulations 2002 (S.I. 576 of 2002), by the Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3 of 2006) and by the European Communities (Amendment of the Medicines Board Act 1995) Regulations 2007 ( S.I. No. 542 of 2007 ); “Board” means the Irish Medicines Board established by section 3 of the Act; “certificate of free sale” means a certificate of free sale issued under section 4

(1)(k)(ii) of the Act; “certificate of registration” means a certificate of registration granted pursuant to the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2010; “certificate of traditional-use registration” means a certificate of traditional-use registration granted pursuant to the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2010 in respect of a traditional herbal medicinal product; “certification of documents” means the certification, under section 4

(1)(k)(ii) of the Act, of documents not being certificates of free sale or export certificates; “complex dossier” refers to an application accompanied by a full dossier in accordance with Directive 2001/83/EC; “decentralised procedure” means the decentralised procedure for human medicinal products provided for in Directive 2001/83/EC; “Directive 2001/83/EC” means Directive 2001/83/EC of the European Parliament and of the Council of 6 November 20011 on the Community code relating to medicinal products for human use, as amended by Directive 2002/98/EC of the European Parliament and of the Council of 27 January 20032 , Commission Directive 2003/63/EC of 25 June 20033 , Directive 2004/24/EC of the European Parliament and of the Council of 31 March 20044 , Directive 2004/27/EC of the European Parliament and of the Council of 31 March 20045 , Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of 12 December 20066 , Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 20077 , Directive 2008/29/EC of the European Parliament and of the Council of 11 March 20088 , Directive 2009/53/EC of the European Parliament and of the Council of 18 June 20099 Commission Directive 2009/120/EC of 14 September 200910 . Directive 2010/84/EU of the European Parliament and of the Council of 15 December 201011 and Directive 2011/62/EU of the European Parliament and of the Council of 8 June 201112 . “export certificate” means a certificate issued under section 4

(1)(k)(ii) of the Act; “homeopathic medicinal product” has the meaning assigned to it by the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2010; “manufacturer’s authorisation” means an authorisation granted pursuant to the Medicinal Products (Control of Manufacture) Regulations 2007 to 2010; “marketing authorisation” means an authorisation granted pursuant to the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2010; “mutual recognition procedure” means the mutual recognition procedure for human medicinal products provided for in Directive 2001/83/EC; “national rules scheme” means the national rules governing the granting of marketing authorisation in respect of homeopathic medicinal products, as provided in Regulation 11 of the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2010; “parallel import licence” has the meaning assigned to it by the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2010; “reduced dossier — complex” refers to an application for a generic medicinal product accompanied by a reduced dossier but containing additional data in circumstances required by Directive 2001/83/EC; “reduced dossier — standard” refers to an application for a generic medicinal product accompanied by a reduced dossier in accordance with Directive 2001/83/EC; “service item” means an application for a medicinal product designated by the Board as qualifying for a reduced application fee on the basis that the product has limited but important uses for which no alternative authorised product exists; “subsequent extension applications” means applications in relation to additional pharmaceutical forms and strengths of a medicinal product, made subsequent to the first application in relation to that product; “switching applications” means applications for a change in the classification of medicinal products under Title VI of Directive 2001/83/EC; “traditional herbal medicinal product” has the meaning assigned to it by the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2010; “type IB variation” and “type II standard variation” shall be classified by the Board in accordance with Commission Regulation (EC) No. 1234/2008 of 24 November 200813 ; “wholesaler’s authorisation” means an authorisation granted pursuant to the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 to 2010;

(2)In these Regulations, unless otherwise indicated— (

1. a)any reference to a Regulation is a reference to a Regulation of these Regulations, and (
2. b)any reference to the Schedule is a reference to the Schedule to these Regulations. 3. Subject to Regulation 4, there shall be paid to the Board in respect of each and every matter set out in column 1 of the Schedule the fee as set out in column 2 of the Schedule. 4. 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 3. 5. The Irish Medicines Board (Fees) Regulations 2010 ( S.I. No. 632 of 2010 ) are hereby revoked. SCHEDULE COLUMN 1 COLUMN 2 Fees for national applications for marketing authorisations € Complex dossier National application 15,211 Each additional form (same time) 5,090 Each additional strength (same time) 656 Additional drug master file submitted 3,251 Reduced dossier — complex National application 11,329 Each additional form (same time) 5,090 Each additional strength (same time) 656 Additional drug master file submitted 3,251 Reduced dossier — standard National application 7,658 Each additional form (same time) 5,090 Each additional strength (same time) 656 Additional drug master file submitted 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 3,251 Fees for applications for marketing authorisations using mutual recognition procedure and decentralised procedure Complex dossier Mutual recognition incoming 10,647 Each additional form (same time) 3,660 Each additional strength (same time) 656 Outgoing mutual recognition supplement 10,962 Decentralised incoming 15,211 Decentralised outgoing 40,000 Each additional form (same time) 5,090 Each additional strength (same time) 656 Reduced dossier — complex Mutual recognition incoming 8,077 Each additional form (same time) 3,251 Each additional strength (same time) 656 Outgoing mutual recognition supplement 10,962 Decentralised incoming 11,329 Decentralised outgoing 30,000 Each additional form (same time) 5,090 Each additional strength (same time) 656 Reduced dossier — standard Mutual recognition incoming 5,350 Each additional form (same time) 2,859 Each additional strength (same time) 656 Outgoing mutual recognition supplement 7,126 Decentralised incoming 7,658 Decentralised outgoing 20,000 Each additional form (same time) 5,090 Each additional strength (same time) 656 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 incoming (first additional form) 7,658 Decentralised outgoing (first additional form) 20,000 Each additional form (same time) 5,090 First additional strength (existing form) 2,756 Each additional strength (same time) 656 Switching applications Switching applications 5,000 Fees for parallel import licences 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 Parallel imports of dual pack registrations 831 Registration of parallel imports — each additional strength or form 495 Parallel imports where the originator is not on the Irish market 5,000 Change of ownership 525 Fees for variations to national marketing authorisations Type IB variation 468 Type IB variation — reduced rate 234 Type II complex variation 2,601 Type II standard variation 506 Type II standard variation — reduced rate 253 Notifications under Article 61

(3)of Directive 2001/83/ EC 250 Notifications under Article 61

(3)of Directive 2001/83/EC — reduced rate 125 Multiple variations capped fee (per product range) 6,200 Multiple variations capped fee (per product) 4,400 Introduction of standard statements from European institutions 1 to 5 authorisations 1,500 6 to 10 authorisations 3,000 11 to 20 authorisations 6,000 21 to 40 authorisations 12,000 41 to 100 authorisations 20,000 101 authorisations and above 30,000 Fees for variations to marketing authorisations under mutual recognition procedure and decentralised procedure Type IB variation outgoing mutual recognition / decentralised supplement 345 Type IB variation — mutual recognition incoming 338 Type IB variation — mutual recognition incoming — reduced rate 174 Type II complex variation — outgoing mutual recognition / decentralised supplement 525 Type II complex variation — mutual recognition incoming 1,797 Type II standard variation — mutual recognition incoming 338 Type II standard variation — mutual recognition incoming — reduced rate 174 Type II standard variation — outgoing mutual recognition / decentralised supplement 338 Notifications made under Article 61

(3)of Directive 2001/83/EC 250 Notifications made under Article 61

(3)of Directive 2001/83/EC — reduced rate 125 Fees for the granting of a marketing authorisation on transfer to another company Change of ownership — related company — 1st marketing authorisation within a range 900 Change of ownership — related company — additional marketing authorisations within a range 321 Change of ownership — non-related company — 1st marketing authorisation within a range 1,316 Change of ownership — non-related company — additional marketing authorisations within a range 321 Other fees relating to the granting of marketing authorisations Service item 612 Fees for applications for wholesaler’s authorisations Application fee 555 Variation to authorisation — minor site technical 400 Variation to authorisations — administrative 219 Variation to authorisation — technical 603 Fees for applications for manufacturer’s authorisations Application fee 1,853 Variation to authorisation — administrative 274 Variation to authorisation — technical 768 Fees for the granting of a manufacturer’s authorisation or a wholesaler’s authorisation 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 applications in relation to medical devices and cosmetic products Certificates of free sale — standard (4 certs per request) 147 Certificates of free sale — fast track (4 certs per request) 277 Duplicate certificates of free sale — each (available at time of initial request) 23 Fees for applications in relation to homeopathic medicinal products New national / decentralised registration standard charge — single stock 678 New national / decentralised registration standard charge — 2 or more stocks 1,016 New application — national rules scheme standard fee — single stock 1,016 New application — national rules scheme standard fee — 2 or more stocks 1,500 Mutual recognition incoming application standard fee — single stock 452 Mutual recognition incoming application standard fee — 2 or more stocks 678 Outgoing mutual recognition / decentralised supplement 564 National variation — registration and national rules scheme 339 National variation — reduced rate — registration and national rules scheme 170 Mutual recognition incoming variation 226 Mutual recognition incoming variation — reduced rate 113 Variation — outgoing mutual recognition / decentralised supplement 170 Fees applications in relation to traditional herbal medicinal products National applications for certificates of traditional-use registration National application 4,888 National application where there is a monograph 3,000 Each additional form (same time) 4,072 Each additional strength (same time) 525 Additional drug master file submitted 3,251 Applications for certificates of traditional-use registration under mutual recognition procedure and decentralised procedure Mutual recognition incoming 3,418 Mutual recognition incoming — each additional form (same time) 2,287 Mutual recognition incoming — each additional strength (same time) 525 Outgoing mutual recognition / decentralised supplement 4,445 Decentralised outgoing/incoming 4,888 Each additional form (same time) 4,072 Each additional strength (same time) 525 Fees for export certificates and certification of documents Standard 147 Fast track 277 Annual maintenance fees Marketing authorisations and registrations First 10 marketing authorisations 650 Additional marketing authorisations 812 Dormant marketing authorisations 420 Parallel import registration 113 Dual pack registration 55 Homeopathic medicinal products 55 Traditional herbal medicinal products 113 Manufacturer’s authorisations Major site (more than 250 employees) 16,669 Large site (150-250 employees) 11,112 Medium site (50-149 employees) 7,409 Small site (less than 50 employees) 3,703 Wholesaler’s authorisations Large full line 2,771 Medium full line 1,576 Minor site 400 Inspection fees Per day (per member of the inspection team) 1,489 Part of day (per hour, per member of the inspection team) 213 Enforcement fees Manufacturers Major site (more than 250 employees) 2,400 Large site (150-250 employees) 1,800 Medium site (50-149 employees) 600 Small site (less than 50 employees) 200 Wholesalers Large full line 600 Medium full line and short line 200 Marketing authorisation / parallel import licence holders > 50 marketing authorisations / parallel import licences 3,150 31-50 marketing authorisations / parallel import licences 1,000 16-30 marketing authorisations / parallel import licences 600 6-15 marketing authorisations / parallel import licences 200 (Note: Companies classed as both manufacturer and wholesaler are charged the higher of the two applicable charges. Marketing authorisation holders pay the marketing authorisation holder fee in addition to any manufacturer / wholesaler fee.) Given under my hand, 21 December 2011. 21 December 2011. RÓISÍN SHORTALL, Minister of State at the Department of Health. 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 . These Regulations revoke the Irish Medicines Board (Fees) Regulations 2010 ( S.I. No. 632 of 2010 ). 1 OJ L 311, 28.11.2001, p. 67. 2 OJ L 33, 8.2.2003, p. 30. 3 OJ L 159, 27.6.2003, p. 46. 4 OJ L 136, 30.4.2004, p. 85. 5 OJ L 136, 30.4.2004, p. 34. 6 OJ L 378, 27.12.2006, p. 1. 7 OJ L 324, 10.12.2007, p. 121. 8 OJ L 81, 20.3.2008, p. 51. 9 OJ L 168, 30.6.2009, p. 33. 10 OJ L 242, 15.9.2009, p. 3. 11 OJ L 348, 31.12.2010, p. 74. 12 OJ L 174, 1.7.2011, p. 74. 13 OJ L 334, 12.12.2008, p. 7. 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