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Notice of the making of this Statutory Instrument was published in
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"Iris Oifigiúil" of 30th December, 2011.
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I, ROISÍN SHORTALL, Minister of State at the Department of Health, in exercise of the powers conferred on me by sections 13 and 32 (as amended by sections 15 and 16 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006 (No. 3 of 2006)) of the Irish Medicines Board Act 1995 (No. 29 of 1995) and the Health (Delegation of Ministerial Functions) (No. 2) Order 2011 ( S.I. No. 493 of 2011 ), hereby make the following Regulations:
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1. These Regulations may be cited as the Irish Medicines Board (Fees) Regulations 2011.
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2. (1) In these Regulations-
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"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 );
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"Board" means the Irish Medicines Board established by section 3 of the Act;
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"certificate of free sale" means a certificate of free sale issued under section 4(1)(k)(ii) of the Act;
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"certificate of registration" means a certificate of registration granted pursuant to the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2010;
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"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;
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"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;
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"complex dossier" refers to an application accompanied by a full dossier in accordance with Directive 2001/83/EC;
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"decentralised procedure" means the decentralised procedure for human medicinal products provided for in Directive 2001/83/EC;
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"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 .
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"export certificate" means a certificate issued under section 4(1)(k)(ii) of the Act;
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"homeopathic medicinal product" has the meaning assigned to it by the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2010;
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"manufacturer's authorisation" means an authorisation granted pursuant to the Medicinal Products (Control of Manufacture) Regulations 2007 to 2010;
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"marketing authorisation" means an authorisation granted pursuant to the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2010;
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"mutual recognition procedure" means the mutual recognition procedure for human medicinal products provided for in Directive 2001/83/EC;
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"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;
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"parallel import licence" has the meaning assigned to it by the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2010;
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"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;
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"reduced dossier - standard" refers to an application for a generic medicinal product accompanied by a reduced dossier in accordance with Directive 2001/83/EC;
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"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;
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"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;
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"switching applications" means applications for a change in the classification of medicinal products under Title VI of Directive 2001/83/EC;
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"traditional herbal medicinal product" has the meaning assigned to it by the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2010;
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"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 ;
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"wholesaler's authorisation" means an authorisation granted pursuant to the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 to 2010;
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(2) In these Regulations, unless otherwise indicated-
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(a) any reference to a Regulation is a reference to a Regulation of these Regulations, and
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(b) any reference to the Schedule is a reference to the Schedule to these Regulations.
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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.
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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.
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5. The Irish Medicines Board (Fees) Regulations 2010 ( S.I. No. 632 of 2010 ) are hereby revoked.
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SCHEDULE
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COLUMN 1
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COLUMN 2
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Fees for national applications for marketing authorisations
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€
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Complex dossier
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National application
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15,211
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Each additional form (same time)
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5,090
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Each additional strength (same time)
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656
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Additional drug master file submitted
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3,251
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Reduced dossier - complex
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National application
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11,329
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Each additional form (same time)
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5,090
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Each additional strength (same time)
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656
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Additional drug master file submitted
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3,251
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Reduced dossier - standard
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National application
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7,658
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Each additional form (same time)
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5,090
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Each additional strength (same time)
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656
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Additional drug master file submitted
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3,251
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Subsequent extension applications
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First additional form
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7,658
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Each additional form (same time)
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5,090
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First additional strength (existing form)
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2,756
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Each additional strength (same time)
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656
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Additional drug master file submitted
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3,251
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Fees for applications for marketing authorisations using mutual recognition procedure and decentralised procedure
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Complex dossier
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Mutual recognition incoming
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10,647
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Each additional form (same time)
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3,660
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Each additional strength (same time)
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656
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Outgoing mutual recognition supplement
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10,962
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Decentralised incoming
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15,211
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Decentralised outgoing
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40,000
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Each additional form (same time)
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5,090
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Each additional strength (same time)
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656
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Reduced dossier - complex
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Mutual recognition incoming
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8,077
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Each additional form (same time)
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3,251
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Each additional strength (same time)
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656
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Outgoing mutual recognition supplement
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10,962
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Decentralised incoming
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11,329
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Decentralised outgoing
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30,000
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Each additional form (same time)
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5,090
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Each additional strength (same time)
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656
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Reduced dossier - standard
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Mutual recognition incoming
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5,350
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Each additional form (same time)
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2,859
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Each additional strength (same time)
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656
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Outgoing mutual recognition supplement
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7,126
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Decentralised incoming
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7,658
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Decentralised outgoing
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20,000
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Each additional form (same time)
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5,090
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Each additional strength (same time)
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656
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Subsequent extension applications
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Mutual recognition incoming (first additional form)
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5,350
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Mutual recognition incoming (first additional strength)
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1,929
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Mutual recognition incoming (subsequent additional strength)
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656
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Outgoing mutual recognition/decentralised supplement (additional form)
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2,859
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Outgoing mutual recognition/decentralised supplement (additional strength)
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656
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Decentralised incoming (first additional form)
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7,658
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Decentralised outgoing (first additional form)
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20,000
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Each additional form (same time)
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5,090
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First additional strength (existing form)
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2,756
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Each additional strength (same time)
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656
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Switching applications
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Switching applications
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5,000
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Fees for parallel import licences
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Application fee - per country at the same time or by variation
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1,662
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Each additional strength per country
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495
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Each additional form per country
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495
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Parallel imports of dual pack registrations
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831
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Registration of parallel imports - each additional strength or form
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495
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Parallel imports where the originator is not on the Irish market
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5,000
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Change of ownership
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525
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Fees for variations to national marketing authorisations
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Type IB variation
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468
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Type IB variation - reduced rate
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234
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Type II complex variation
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2,601
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Type II standard variation
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506
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Type II standard variation - reduced rate
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253
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Notifications under Article 61(3) of Directive 2001/83/ EC
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250
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Notifications under Article 61(3) of Directive 2001/83/EC - reduced rate
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125
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Multiple variations capped fee (per product range)
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6,200
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Multiple variations capped fee (per product)
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4,400
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Introduction of standard statements from European institutions
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1 to 5 authorisations
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1,500
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6 to 10 authorisations
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3,000
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11 to 20 authorisations
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6,000
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21 to 40 authorisations
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12,000
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41 to 100 authorisations
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20,000
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101 authorisations and above
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30,000
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Fees for variations to marketing authorisations under mutual recognition procedure and decentralised procedure
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Type IB variation outgoing mutual recognition / decentralised supplement
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345
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Type IB variation - mutual recognition incoming
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338
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Type IB variation - mutual recognition incoming - reduced rate
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174
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Type II complex variation - outgoing mutual recognition / decentralised supplement
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525
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Type II complex variation - mutual recognition incoming
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1,797
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Type II standard variation - mutual recognition incoming
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338
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Type II standard variation - mutual recognition incoming - reduced rate
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174
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Type II standard variation - outgoing mutual recognition / decentralised supplement
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338
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Notifications made under Article 61(3) of Directive 2001/83/EC
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250
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Notifications made under Article 61(3) of Directive 2001/83/EC - reduced rate
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125
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Fees for the granting of a marketing authorisation on transfer to another company
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Change of ownership - related company - 1st marketing authorisation within a range
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900
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Change of ownership - related company - additional marketing authorisations within a range
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321
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Change of ownership - non-related company - 1st marketing authorisation within a range
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1,316
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Change of ownership - non-related company - additional marketing authorisations within a range
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321
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Other fees relating to the granting of marketing authorisations
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Service item
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612
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Fees for applications for wholesaler's authorisations
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Application fee
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555
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Variation to authorisation - minor site technical
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400
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Variation to authorisations - administrative
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219
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Variation to authorisation - technical
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603
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Fees for applications for manufacturer's authorisations
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Application fee
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1,853
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Variation to authorisation - administrative
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274
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Variation to authorisation - technical
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768
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Fees for the granting of a manufacturer's authorisation or a wholesaler's authorisation on transfer to another company
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Manufacture - related companies
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1,107
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Manufacture - unrelated companies
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1,853
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Wholesale - related companies
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365
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Wholesale - unrelated companies
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555
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Fees for applications in relation to medical devices and cosmetic products
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Certificates of free sale - standard (4 certs per request)
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147
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Certificates of free sale - fast track (4 certs per request)
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277
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Duplicate certificates of free sale - each (available at time of initial request)
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23
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Fees for applications in relation to homeopathic medicinal products
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New national / decentralised registration standard charge - single stock
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678
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New national / decentralised registration standard charge - 2 or more stocks
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1,016
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New application - national rules scheme standard fee - single stock
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1,016
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New application - national rules scheme standard fee - 2 or more stocks
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1,500
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Mutual recognition incoming application standard fee - single stock
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452
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Mutual recognition incoming application standard fee - 2 or more stocks
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678
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Outgoing mutual recognition / decentralised supplement
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564
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National variation - registration and national rules scheme
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339
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National variation - reduced rate - registration and national rules scheme
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170
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Mutual recognition incoming variation
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226
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Mutual recognition incoming variation - reduced rate
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113
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Variation - outgoing mutual recognition / decentralised supplement
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170
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Fees applications in relation to traditional herbal medicinal products
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National applications for certificates of traditional-use registration
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National application
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4,888
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National application where there is a monograph
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3,000
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Each additional form (same time)
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4,072
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Each additional strength (same time)
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525
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Additional drug master file submitted
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3,251
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Applications for certificates of traditional-use registration under mutual recognition procedure and decentralised procedure
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Mutual recognition incoming
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3,418
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Mutual recognition incoming - each additional form (same time)
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2,287
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Mutual recognition incoming - each additional strength (same time)
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525
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Outgoing mutual recognition / decentralised supplement
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4,445
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Decentralised outgoing/incoming
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4,888
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Each additional form (same time)
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4,072
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Each additional strength (same time)
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525
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Fees for export certificates and certification of documents
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Standard
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147
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Fast track
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277
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Annual maintenance fees
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Marketing authorisations and registrations
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First 10 marketing authorisations
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650
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Additional marketing authorisations
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812
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Dormant marketing authorisations
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420
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Parallel import registration
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113
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Dual pack registration
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55
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Homeopathic medicinal products
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55
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Traditional herbal medicinal products
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113
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Manufacturer's authorisations
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Major site (more than 250 employees)
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16,669
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Large site (150-250 employees)
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11,112
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Medium site (50-149 employees)
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7,409
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Small site (less than 50 employees)
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3,703
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Wholesaler's authorisations
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Large full line
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2,771
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Medium full line
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1,576
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Minor site
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400
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Inspection fees
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Per day (per member of the inspection team)
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1,489
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Part of day (per hour, per member of the inspection team)
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213
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Enforcement fees
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Manufacturers
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Major site (more than 250 employees)
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2,400
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Large site (150-250 employees)
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1,800
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Medium site (50-149 employees)
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600
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Small site (less than 50 employees)
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200
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Wholesalers
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Large full line
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600
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Medium full line and short line
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200
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Marketing authorisation / parallel import licence holders
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> 50 marketing authorisations / parallel import licences
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3,150
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31-50 marketing authorisations / parallel import licences
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1,000
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16-30 marketing authorisations / parallel import licences
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600
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6-15 marketing authorisations / parallel import licences
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200
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(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.)
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Given under my hand, 21 December 2011.
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21 December 2011.
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RÓISÍN SHORTALL,
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Minister of State at the Department of Health.
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EXPLANATORY NOTE
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(This note is not part of the instrument and does not purport to be a legal instrument.)
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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 .
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These Regulations revoke the Irish Medicines Board (Fees) Regulations 2010 ( S.I. No. 632 of 2010 ).
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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.
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