S.I. No. 602/2016 - Health Products Regulatory Authority (Fees) Regulations 2016.

(1)(as amended by Regulation 3 of the Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013 ( S.I. No. 164 of 2013 )) of the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (S.I. 538 of 2007); “brokers register” means the register maintained by the Authority in pursuance of Regulation 14D (inserted by Regulation 6 of the Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013) of the Medicinal Products (Control of Wholesale Distribution) Regulations 2007; “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 2014; “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 2014 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 , 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 , Directive 2011/62/EU of the European Parliament and of the Council of 8 June 201112 and Directive 2012/26/EU of the European Parliament and of the Council of 25 October 201213 . “distributor”, in the context of medical devices, means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a medical device available on the market; “listed organisation” has the meaning assigned to it by Regulation 4

(1)(as amended by Regulation 3 of the Medicinal Products (Prescription and Control of Supply) (Amendment) (No. 2) Regulations 2015 ( S.I. No. 449 of 2015 )) of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 ( S.I. No. 540 of 2003 ); “export certificate” means a certificate issued under section 4

(1)(k)(ii) of the Act; “follow-up inspections” means inspections other than routine inspections; “homeopathic medicinal product” has the meaning assigned to it by Regulation 3

(1)of the Medicinal Products (Control of Placing on the Market) Regulations 2007 ( S.I. No. 540 of 2007 ); “individual authorisation” means an authorisation granted to an individual under Part 8 of the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 to 2016; “manufacturer”, in the context of medical devices, means— (

1. a)a person who is responsible for the design, manufacture, packaging and labelling of a medical device before it is placed on the market under his or her own name, regardless of whether these operations are carried out by that person himself or herself or on his or her behalf by a third party, or (
2. b)a person who assembles, packages, processes, fully refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a medical device with a view to their being placed on the market under his or her own name, but not including a person who assembles or adapts medical devices already on the market to their intended purpose for an individual patient; “manufacturer’s authorisation” means an authorisation granted pursuant to the Medicinal Products (Control of Manufacture) Regulations 2007 to 2013; “manufacturing site”, in the context of medical devices, means a site where an entity— (
3. a)manufactures a medical device, (
4. b)manufactures critical components of a medical device to a set of specifications, (
5. c)carries out packaging activities in relation to a medical device, or (
6. d)carries out labelling activities in relation to a medical device; “marketing authorisation” means an authorisation granted pursuant to the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2014; “medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of— (
7. a)diagnosis, prevention, monitoring, treatment or alleviation of disease, (
8. b)diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, (
9. c)investigation, replacement or modification of the anatomy or of a physiological process, or (
10. d)control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means, and includes— (
11. i)an in vitro diagnostic medical device in accordance with the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 to 2012, and (
12. ii)an active implantable medical device in accordance with the European Communities (Active Implantable Medical Devices) Regulations 1994 to 2009; “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; “notified body” means, in relation to any task, a body designated and notified in respect of that task in accordance with the European Communities (Medical Devices) Regulations 1994 to 2009, the European Communities (Active Implantable Medical Devices) Regulations 1994 to 2009, or the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 to 2012; “organ establishment authorisation” means an authorisation granted pursuant to the European Union (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012 and 2014; “parallel import licence” has the meaning assigned to it by Regulation 3

(1)of the Medicinal Products (Control of Placing on the Market) Regulations 2007; “project” means a programme of work having a defined scientific objective and involving one or more procedures pursuant to the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 to 2016; “project authorisation” means an authorisation granted pursuant to the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 to 2016; “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 Authority 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; “supplier authorisation” means an authorisation granted pursuant to the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 to 2016; “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 Regulation 3

(1)of the Medicinal Products (Control of Placing on the Market) Regulations 2007; “type IB variation” and “type II standard variation” shall be classified by the Authority in accordance with Commission Regulation (EC) No. 1234/2008 of 24 November 200814 , as amended by Commission Regulation (EU) No 712/2012 of 3 August 201215 ; “user authorisation” means an authorisation granted to a user pursuant to the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 to 2016; “wholesaler’s authorisation” means an authorisation granted pursuant to the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 to

2. Subject to Regulation 4, there shall be paid to the Authority 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.
3. The Authority 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. The Health Products Regulatory Authority (Fees) Regulations 2015 ( S.I. No. 599 of 2015 ) are 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 mutualrecognition 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 Additional supplement where there are 15 or more concerned Member States 1,000 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 Additional supplement where there are 15 or more concerned Member States 1,000 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 Additional supplement where there are 15 or more concerned Member States 1,000 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 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 Additional supplement where there are 15 or more concerned Member States 1,000 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 — dual pack registration 831 Dual pack 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 per product range 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) 4,800 Multiple variations capped fee (per product) 3,100 Worksharing capped fee 5,200 Fees for variations to marketing authorisations under mutualrecognition 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 toanother company Change of ownership — related company — 1st marketing authorisation within a range 900 Change of ownership — related company — each additional marketing authorisation within a range 321 Change of ownership — non-related company — 1st marketing authorisation within a range 1,316 Change of ownership — non-related company — each additional marketing authorisation within a range 321 Other fees relating to the granting of marketing authorisations Service item 612 Notification to become a listed organisation Notification Fee 10 Fees for applications for wholesaler’s authorisations Application fee 555 Variation to authorisation — minor site technical 400 Variation to authorisation — 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 applications in relation to brokers register and activesubstances register Registration fee 250 Immediate notification of a change which may impact on the quality or safety of the active substances 768 Notification of an administrative change to the active substances register 136 Notification of any change to the brokers register 136 Fees for applications for organ establishment authorisations Application charge 1,853 Variation to authorisation — administrative 274 Variation to authorisation — technical 768 Appeal to amend/revoke an authorisation 500 Fees for transferring of authorisation/registration to another company Manufacturer’s authorisation and organ establishment authorisationRelated companies 1,107 Unrelated companies 1,853 Wholesaler’s authorisation, registration on brokers register and registration on active substances registerRelated companies 365 Unrelated companies 555 Fees for applications in relation to 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 — registrations and national rules scheme 170 Mutual recognition incoming variation 226 Mutual recognition incoming variation — reduced rate 113 Variation — outgoing mutual recognition / decentralised supplement 170 Bulk variation for multiple changes to the Masterfile 2,038 Fees for 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 Extension applications First additional form 4,888 Each additional form (same time) 4,072 First additional strength 2,205 Each additional strength (same time) 525 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 Traditional herbal medicinal products — national variations Type IB variation — national 375 Type IB variation — reduced rate 190 Type II standard variation 400 Type II standard variation — reduced rate 200 Type II complex variation 2,100 Bulk variation for multiple changes 4,200 Traditional herbal medicinal products — mutual recognition variations Type IB variation — mutual recognition incoming 270 Type IB variation — mutual recognition incoming — reduced rate 140 Type IB variation — outgoing mutual recognition supplement 275 Type II standard — mutual recognition incoming 270 Type II standard — mutual recognition incoming — reduced rate 140 Type II standard — outgoing mutual recognition supplement 270 Type II complex — mutual recognition incoming 1,435 Type II complex — outgoing mutual recognition supplement 420 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 licence 113 Parallel import licence — Dual pack registration 55 Certificate of registration — homeopathic medicinal products 55 Certificate of traditional-use registration — 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 Homeopathic manufacturing site 1,000 Wholesaler’s authorisations Large full line 2,771 Medium full line/ short line 1,576 Small short line 600 Minor site 400 Procure and supply only 350 Active substances register Active substances distributor 250 Active substances importer 500 Active substances manufacturer 1,000 Organ establishment authorisations Major establishment (more than 250 employees) 16,669 Large establishment (150-250 employees) 11,112 Medium establishment (50-149 employees) 7,409 Small establishment (less than 50 employees) 3,703 Minor establishment (less than 5 employees) 1,000 Project fees Project application without ethical approval 2,000 Fast track project application 2,000 Breeder/Supplier/User Authorisation fees Band 1: Small establishment with no animal facilities or establishment with 1-3 individual authorisation holders 275 Band 2: Establishment with 4-10 individual authorisation holders 550 Band 3: Establishment with 11-20 individual authorisation holders 850 Band 4: Establishment with 21-50 individual authorisation holders 1,600 Band 5: Establishment with 51-100 individual authorisation holders 3,250 Band 6: Establishment with 101-150 individual authorisation holders 5,500 Band 7: Establishment with 151 — 200 individual authorisation holders 8,000 Band 8: Establishment with >201 individual authorisation holders 10,500 Individual authorisation fees Application fee 200 Annual fee 200 Once-off authorisation — procedural training for a period of two months or less (reduced fee) 75 Fees for follow-up inspections Per day (per member of the inspection team) 1,489 Part of day (per hour, per member of the inspection team) 213 Inspection/Audit fees (other than inspections in relation to theprotection of animals used for scientific purposes) 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 / 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.) Fees in relation to medical devices Manufacturers and authorised representatives — annual fees Manufacturer — more than 150 employees 30,000 Manufacturer — 50-150 employees 25,000 Manufacturer — 15-49 employees 15,000 Manufacturer — 5-15 employees 5,000 Manufacturer — less than 5 employees or annual turnover of less than €500,000 250 Manufacturer/authorised representative fee per entity (subject to a maximum of €10,000) Authorised representative which is not a manufacturer (of medical devices) (maximum of €30,000) 1,000 5,000 (Note: Where one organisation has multiple manufacturing sites based in Ireland, the organisation will be charged per manufacturing site to a maximum fee of €60,000.) Distributors — annual fees Large distributor (turnover greater than €15 million) 5,500 Medium distributor (turnover €3-€15 million) 3,500 Small distributor (turnover under €3 million) 1,250 Distributor turnover less than €500,000 250 Notified Body — annual fees 3,000 Certificates of free sale for medical devices Certificate of free sale (4 certificates per request) 250 Duplicate certificates of free sale — each (available at time of request) 23 GIVEN under my Official Seal, 6 December 2016. SIMON HARRIS, Minister for 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 Health Products Regulatory Authority (formerly the Irish Medicines Board) pursuant to Section 13 of the Irish Medicines Board Act 1995 . These Regulations revoke the Health Products Regulatory Authority (Fees) Regulations 2015 ( S.I. No. 599 of 2015 ). These Regulations may be cited as the Health Products Regulatory Authority (Fees) Regulations 2016. 1 OJ No. L 311, 28.11.2001, p. 67. 2 OJ No. L 33, 8.2.2003, p. 30. 3 OJ No. L 159, 27.6.2003, p. 46. 4 OJ No. L 136, 30.4.2004, p. 85. 5 OJ No. L 136, 30.4.2004, p. 34. 6 OJ No. L 378, 27.12.2006, p. 1. 7 OJ No. L 324, 10.12.2007, p. 121. 8 OJ No. L 81, 20.3.2008, p. 51. 9 OJ No. L 168, 30.6.2009, p. 33. 10 OJ No. L 242, 15.9.2009, p. 3. 11 OJ No. L 348, 31.12.2010, p. 74. 12 OJ No. L 174, 1.7.2011, p. 74. 13 OJ No. L 299, 27.10.2012, p. 1. 14 OJ No. L 334, 12.12.2008, p. 7. 15 OJ No. L 209, 4.8.2012, p. 4. 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. 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