S.I. No. 697/2023 - Health Products Regulatory Authority (Fees) Regulations 2023

(1)(inserted by Regulation 3(

1. a)of the Medicinal Products (Control of Manufacture) (Amendment) Regulations 2013 ( S.I. No. 163 of 2013 )) of the Medicinal Products (Control of Manufacture) Regulations 2007 ( S.I. No. 539 of 2007 ); “authorised representative” means a person established within the European Economic Area who, explicitly designated by the manufacturer, acts for the manufacturer and may be addressed by authorities and bodies in the European Economic Area instead of the manufacturer with respect to the European Communities (Medical Devices) Regulations 1994 ( S.I. No. 252 of 1994 ), the European Communities (Active Implantable Medical Devices) Regulations 1994 ( S.I. No. 253 of 2004 ), or the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 ( S.I. No. 304 of 2001 ), or has the meaning assigned to it by— (
2. a)Article 2

(32)of the Medical Devices Regulation, or (b) Article 2

(25)of the IVD Medical Devices Regulation, as applicable; “Authority” means the Health Products Regulatory Authority; “breeder authorisation” has the meaning assigned to it by Regulation 3

(1)of the Protection of Animals Regulations; “broker” means a person carrying out the brokering of medicinal products, as defined in Regulation 4

(1)(as amended by Regulation 3(a) of the Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013 ( S.I. No. 164 of 2013 )) of the Control of Wholesale Distribution Regulations; “brokers register” has the meaning assigned to it by Regulation 4

(1)(as amended by Regulation 3(

1. a)of the Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013) of the Control of Wholesale Distribution Regulations; “certificate of free sale” means – (
2. a)a certificate of free sale issued under section 4

(1)(k)(

1. ii)(as amended by section 11(a)(iii) of the Act of 2006) of the Act of 1995, (
2. b)a certificate of free sale issued under Article 60 of the Medical Devices Regulation, or (
3. c)a certificate of free sale issued under Article 55 of the IVD Medical Devices Regulation; “certificate of registration” has the meaning assigned to it by Regulation 3

(1)of the Control of Placing on the Market Regulations; “certificate of traditional-use registration” has the meaning assigned to it by Regulation 3

(1)of the Control of Placing on the Market Regulations; “certification of documents” means the certification, under section 4

(1)(k)(

1. ii)(as amended by section 11(a)(iii) of the Act of 2006) of the Act of 1995, 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; “Control of Placing on the Market Regulations” means the Medicinal Products (Control of Placing on the Market) Regulations 2007 ( S.I. No. 540 of 2007 ); “Control of Wholesale Distribution Regulations” means the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 ( S.I. No. 538 of 2007 ); “decentralised procedure” means the decentralised procedure for human medicinal products provided for in Directive 2001/83/EC; “device” means – (
2. a)a medical device, (
3. b)an accessory for a medical device, (
4. c)a product listed in Annex XVI to the Medical Devices Regulation, provided that the Medical Devices Regulation applies to such product pursuant to Article 1

(2)thereof, (

1. d)an in vitro diagnostic medical device, or (
2. e)an accessory for an in vitro diagnostic medical device, but does not include- (
3. i)a product or other substance excluded by Article 1

(6)(

1. b)to (
2. i)of the Medical Devices Regulation, (
3. ii)a product or other substance excluded from the scope of the IVD Medical Devices Regulation by Article 1

(3)thereof, (iii) a device referred to in the second subparagraph of Article 1

(8),

(9)or

(10)of the Medical Devices Regulation, or (iv) an in-house device; “Directive 2001/83/EC” means Directive 2001/83/EC of the European Parliament and of the Council of 6 November 20011 ; “distributor”, in the context of devices, means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service; “export certificate” means an export certificate issued under section 4

(1)(k)(ii) (as amended by section 11(a)(iii) of the Act of 2006) of the Act of 1995; “European Union Reference Laboratory” means a laboratory designated under Article 100 of the IVD Medical Devices Regulation. “follow-up inspections” means inspections other than routine inspections; “homeopathic medicinal product” has the meaning assigned to it by Regulation 3

(1)of the Control of Placing on the Market Regulations; “importer”, in the context of devices, means any natural or legal person established within the European Economic Area that places a device from a third country on the market in the European Economic Area; “individual authorisation” means an authorisation granted to an individual under Part 8 of the Protection of Animals Regulations; “investigational medicinal product” has the meaning assigned to it by Regulation 3

(1)(as amended by Regulation 4(

1. g)of the Medicinal Products (Control of Manufacture) (Amendment) Regulations 2022 ( S.I. No. 43 of 2022 )) of the Medicinal Products (Control of Manufacture) Regulations 2007; “in vitro diagnostic medical device” has the meaning assigned to it by— (
2. a)Article 2

(2)of the IVD Medical Devices Regulation, or (b) Regulation 2

(1)of the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 ( S.I. No. 304 of 2001 ), as applicable; “IVD Medical Devices Regulation” means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 20172 ; “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. 4) Regulations 2021 ( S.I. No. 81 of 2021 )) of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 ( S.I. No. 540 of 2003 ); “manufacturer”, in the context of devices, means 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 device with a view to their being placed on the market under his or her own name, but not including a person which assembles or adapts devices already on the market to their intended purpose for an individual patient, or has the meaning assigned to it by— (a) Regulation 2

(1)of the European Communities (Medical Devices) Regulations 1994, (b) Regulation 2

(1)of the European Communities (Active Implantable Medical Devices) Regulations 1994, (c) by Regulation 2

(1)of the European Communities (In vitro Diagnostic Medical Devices) Regulations 2001, (d) Article 2

(30)of the Medical Devices Regulation, or (e) Article 2

(23)of the IVD Medical Devices Regulation, as applicable; “manufacturer’s authorisation” has the meaning assigned to it by Regulation 3

(1)of the Medicinal Products (Control of Manufacture) Regulations 2007; “manufacturing facility”, in the context of devices, means a place where an entity, which does not place devices on the market under its own name or under its own trademark— (

1. a)manufactures a device, (
2. b)manufactures one or more critical components of a device to a set of specifications, (
3. c)carries out packaging activities in relation to a device, or (
4. d)carries out labelling activities in relation to a device; “marketing authorisation” means a marketing authorisation granted pursuant to the Control of Placing on the Market Regulations; “medical device” has the meaning— (
5. a)assigned to it by Article 2

(1)of the Medical Devices Regulation, (b) assigned to it by Article 2

(2)of the IVD Medical Devices Regulation, (c) assigned to the term “device” by Regulation 2

(1)of the European Communities (Medical Devices) Regulations 1994, or (d) assigned to the term “device” by Regulation 2

(1)of the European Communities (Active Implantable Medical Devices) Regulations 1994, as applicable; “Medical Devices Regulation” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 20173 ; “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 Control of Placing on the Market Regulations; “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, the European Communities (Active Implantable Medical Devices) Regulations 1994, or the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001, or has the meaning assigned to it by— (a) Article 2

(42)of the Medical Devices Regulation, or (b) Article 2

(34)of the IVD Medical Devices Regulation, as applicable; “organ establishment authorisation” means an authorisation granted pursuant to Regulation 6 of the European Union (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012 ( S.I. No. 325 of 2012 ); “parallel import licence” has the meaning assigned to it by Regulation 3

(1)of the Control of Placing on the Market Regulations; “project” and “project authorisation” have the meanings assigned to them by Regulation 3

(1)of the Protection of Animals Regulations; “Protection of Animals Regulations” means the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 ( S.I. No. 543 of 2012 ); “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” has the meaning assigned to it by Regulation 3

(1)of the Protection of Animals Regulations; “system or procedure pack producer” means a natural or legal person referred to in— (a) Article 22

(1),

(2)or

(3)of the Medical Devices Regulation, or (b) Article 12 of Council Directive 93/42/EEC of 14th June 19934 , as applicable; “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 Control of Placing on the Market Regulations; “type IA variation”, “type IB variation” and “type II standard variation” refer to classifications by the Authority in accordance with Commission Regulation (EC) No. 1234/2008 of 24 November 20085 ; “user authorisation” has the meaning assigned to it by Regulation 3

(1)of the Protection of Animals Regulations; “wholesaler’s authorisation” has the meaning assigned to it by Regulation 4

(1)of the Medicinal Products (Control of Wholesale Distribution) Regulations

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 corresponding fee 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 2022 ( S.I. No. 679 of 2022 ) are revoked. SCHEDULE COLUMN 1 COLUMN 2 Fees for national applications for marketing authorisations € Complex dossier National application 22,570 Each additional form (same time) 7,900 Each additional strength (same time) 1,125 Additional drug master file submitted 4,510 Reduced dossier – complex National application 16,925 Each additional form (same time) 7,900 Each additional strength (same time) 1,125 Additional drug master file submitted 4,510 Reduced dossier – standard National application 11,285 Each additional form (same time) 7,900 Each additional strength (same time) 1,125 Additional drug master file submitted 4,510 Subsequent extension applications First additional form 11,285 Each additional form (same time) 7,900 First additional strength (existing form) 3,385 Each additional strength (same time) 1,125 Additional drug master file submitted 4,510 Fees for applications for marketing authorisations using mutual recognition procedure and decentralised procedure Complex dossier Mutual recognition incoming 15,800 Each additional form (same time) 5,645 Each additional strength (same time) 1,125 Outgoing mutual recognition supplement 16,925 Outgoing mutual recognition supplement – mutual recognition applied for within twelve months of the national procedure ending 16,925 Decentralised incoming 22,570 Decentralised outgoing 56,425 Each additional form (same time) 7,900 Each additional strength (same time) 1,125 Additional supplement where there are 15 or more concerned Member States 1,695 Reduced dossier – complex Mutual recognition incoming 11,285 Each additional form (same time) 5,645 Each additional strength (same time) 1,125 Outgoing mutual recognition supplement 16,925 Outgoing mutual recognition supplement – mutual recognition applied for within twelve months of the national procedure ending 11,285 Decentralised incoming 16,925 Decentralised outgoing 45,135 Each additional form (same time) 7,900 Each additional strength (same time) 1,125 Additional supplement where there are 15 or more concerned Member States 1,695 Reduced dossier – standard Mutual recognition incoming 7,900 Each additional form (same time) 4,510 Each additional strength (same time) 1,125 Outgoing mutual recognition supplement 11,285 Outgoing mutual recognition supplement – mutual recognition applied for within twelve months of the national procedure ending 6,770 Decentralised incoming 11,285 Decentralised outgoing 29,340 Each additional form (same time) 7,900 Each additional strength (same time) 1,125 Additional supplement where there are 15 or more concerned Member States 1,695 Subsequent extension applications Mutual recognition incoming (first additional form) 7,900 Mutual recognition incoming (first additional strength) 2,260 Mutual recognition incoming (subsequent additional strength) 1,125 Outgoing mutual recognition/decentralised supplement (additional form) 3,385 Outgoing mutual recognition/decentralised supplement (additional strength) 1,125 Decentralised incoming (first additional form) 11,285 Decentralised outgoing (first additional form) 29,340 Each additional form (same time) 7,900 First additional strength (existing form) 3,385 Each additional strength (same time) 1,125 Additional supplement where there are 15 or more concerned Member States 1,695 Switching applications Switching applications 5,755 Application fee - per country at the same time or by variation 2,070 Each additional strength per country 615 Each additional form per country 615 Parallel imports - dual pack registration 1,035 Dual pack registration of parallel imports - each additional strength or form 615 Parallel imports where the originator is not on the Irish market 6,215 Change of ownership per product range 655 Fees for variations to national marketing authorisations Type IB variation 580 Type IB variation - reduced rate 295 Type II complex variation 3,235 Type II complex variation – reduced rate 630 Type II standard variation 630 Type II standard variation - reduced rate 315 Notifications under Article 61

(3)of Directive 2001/83/ EC 310 Notifications under Article 61

(3)of Directive 2001/83/EC - reduced rate 155 Multiple variations capped fee (per product range) 5,970 Multiple variations capped fee (per product) 3,855 Worksharing capped fee 6,465 Fees for variations to marketing authorisations under mutual recognition procedure and decentralised procedure Type IA variation outgoing mutual recognition / decentralised supplement 310 Type IB variation outgoing mutual recognition / decentralised supplement 430 Type IB variation - mutual recognition incoming 420 Type IB variation - mutual recognition incoming - reduced rate 220 Type II complex variation - outgoing mutual recognition / decentralised 655 Supplement Type II complex variation - mutual recognition incoming 2,235 Type II complex variation – mutual recognition incoming – reduced rate 420 Type II standard variation - mutual recognition incoming 420 Type II standard variation - mutual recognition incoming - reduced rate 220 Type II standard variation - outgoing mutual recognition / decentralized supplement 420 Notifications made under Article 61

(3)of Directive 2001/83/EC 310 Notifications made under Article 61

(3)of Directive 2001/83/EC – reduced rate 155 Fees for the granting of a marketing authorisation on transfer to another company Change of ownership - related company – 1st marketing authorisation within a range 1,115 Change of ownership - related company – each additional marketing authorisation within a range 395 Change of ownership - non-related company – 1st marketing authorisation within a range 1,640 Change of ownership - non-related company – each additional marketing authorisation within a range 395 Other fees relating to the granting of marketing authorisations Service item 755 Notification to become a listed organisation Notification Fee 10 Fees for applications for wholesaler’s authorisations Application fee 690 Variation to authorisation - minor site technical 495 Variation to authorisation – administrative 270 Variation to authorisation – technical 745 Fees for applications for manufacturer’s authorisations Application fee 2,300 Variation to authorisation – administrative 345 Variation to authorisation – technical 960 Variation to authorisation – fast track 1,355 Fees for applications in relation to brokers register and active substances register Registration fee – importers and distributors of active substances and brokers 310 Registration fee – manufacturers of active substances 550 Immediate notification of a change which may impact on the quality or safety of the active substances 960 Notification of an administrative change to the active substances register 175 Notification of any change to the brokers register 175 Fees for applications for organ establishment authorisations Application charge 2,300 Variation to authorisation – administrative 345 Variation to authorisation – technical 960 Appeal to amend/revoke an authorisation 620 Scientific opinion on the non-viability of the cells/tissue, donation, procurement testing 3,320 Fees for transferring of authorisation/registration to another company Manufacturer’s authorisation and organ establishment authorisation Related company 1,375 Unrelated company 2,300 Wholesaler’s authorisation, registration on brokers register and registration on active substances register Related company 450 Unrelated company 690 Certificates of free sale – standard (4 certificates per request) 185 Certificates of free sale – fast track (4 certificates per request) 345 Duplicate certificates of free sale – each (available at time of initial request) 25 New national / decentralised registration standard charge - single stock 840 New national / decentralised registration standard charge - 2 or more stocks 1,265 New application - national rules scheme standard fee - single stock 1,265 New application - national rules scheme standard fee - 2 or more stocks 1,865 Mutual recognition incoming application standard fee - single stock 565 Mutual recognition incoming application standard fee - 2 or more stocks 840 Outgoing mutual recognition / decentralised supplement 700 National variation – registration and national rules scheme 420 National variation – reduced rate – registrations and national rules scheme 210 Mutual recognition incoming variation 285 Mutual recognition incoming variation - reduced rate 135 Variation – outgoing mutual recognition / decentralised supplement 210 Bulk variation for multiple changes to the Masterfile 2,530 Fees for applications in relation to traditional herbal medicinal products National applications for certificates of traditional-use registration National application 6,080 National application where there is a monograph 3,730 Each additional form (same time) 5,060 Each additional strength (same time) 655 Additional drug master file submitted 4,045 Extension applications First additional form 6,080 Each additional form (same time) 5,060 First additional strength 2,745 Each additional strength (same time) 655 Applications for certificates of traditional-use registration under mutual recognition procedure and decentralised procedure Mutual recognition incoming 4,250 Mutual recognition incoming - each additional form (same time) 2,840 Mutual recognition incoming - each additional strength (same time) 655 Outgoing mutual recognition / decentralised supplement 5,525 Decentralised outgoing/incoming 6,080 Each additional form (same time) 5,060 Each additional strength (same time) 655 Traditional herbal medicinal products – national variations Type IB variation – national 465 Type IB variation – reduced rate 240 Type II standard variation 495 Type II standard variation – reduced rate 250 Type II complex variation 2,610 Bulk variation for multiple changes 5,220 Traditional herbal medicinal products – mutual recognition variations Type IB variation – mutual recognition incoming 335 Type IB variation – mutual recognition incoming - reduced rate 175 Type IB variation – outgoing mutual recognition supplement 345 Type II standard – mutual recognition incoming 335 Type II standard – mutual recognition incoming - reduced rate 175 Type II standard – outgoing mutual recognition supplement 335 Type II complex – mutual recognition incoming 1,785 Type II complex – outgoing mutual recognition supplement 520 Fees for export certificates and certification of documents Standard 185 Fast track 345 Annual maintenance fees Marketing authorisations and registrations First 10 marketing authorisations 805 Additional marketing authorisation 1,005 Dormant marketing authorisation 463 Parallel import licence 135 Parallel import licence - Dual pack 65 Certificate of registration - homeopathic medicinal products 65 Certificate of traditional-use registration - traditional herbal medicinal Products 135 Manufacturer’s authorisations Major site (more than 250 employees) 24,340 Large site (150-250 employees) 16,595 Medium site (50-149 employees) 11,065 Small site (less than 50 employees) 4,980 Homeopathic manufacturing site 1,245 Wholesaler’s authorisations Large full line 3,445 Medium full line / short line 1,960 Small short line 745 Minor site / Procure & supply 495 Active substances register Active substances distributor 310 Active substances importer 620 Active substances manufacturer 1,245 Organ establishment authorisations Major establishment (more than 250 employees) 20,720 Large establishment (150-250 employees) 13,815 Medium establishment (50-149 employees) 9,210 Small establishment (less than 50 employees) 4,605 Minor establishment (less than 5 employees) 1,245 Fees in relation to protection of animals used for scientific purposes Project authorisation fees Project application without ethical approval 2,270 Fast track project application 2,270 Breeder/Supplier/User Authorisation fees Band 1: Small establishment with no animal facilities or establishment with 1-3 individual authorisation holders 330 Band 2: Establishment with 4-10 individual authorisation holders 655 Band 3: Establishment with 11-20 individual authorisation holders 1,005 Band 4: Establishment with 21-40 individual authorisation holders 1,900 Band 5: Establishment with 41-70 individual authorisation holders 2,890 Band 6: Establishment with 71-100 individual authorisation holders 3,860 Band 7: Establishment with 101-150 individual authorisation holders 6,530 Band 8: Establishment with 151 – 200 individual authorisation holders 9,500 Band 9: Establishment with >200 individual authorisation holders 12,470 Individual authorisation fees Application fee 320 Annual fee 320 Once-off authorisation - procedural training for a period of two months or less (reduced fee) 110 Fees for follow-up inspections Per day (per member of the inspection team) 1,850 Part of day (per hour, per member of the inspection team) 265 Inspection/Audit fees (other than inspections in relation to the protection of animals used for scientific purposes) Per day (per member of the inspection team) 1,850 Part of day (per hour, per member of the inspection team) 265 Inspection cancellation/rescheduling fee 505 Enforcement fees Manufacturers Major site (more than 250 employees) 2,985 Large site (150-250 employees) 2,240 Medium site (50-149 employees) 745 Small site (less than 50 employees) 250 Wholesalers Large full line 745 Medium full line / short line 250 Marketing authorisation / parallel import licence holders > 50 marketing authorisations / parallel import licences 3,920 31-50 marketing authorisations / parallel import licences 1,245 16-30 marketing authorisations / parallel import licences 745 6-15 marketing authorisations / parallel import licences 250 (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’s authorisation / wholesaler’s authorisation fee.) Fees in relation to devices Manufacturer or system and procedure pack producer or manufacturing facility located in Ireland – annual fees Manufacturer or system and procedure pack producer or manufacturing facility - with more than 150 employees 31,060 Manufacturer or system and procedure pack producer or manufacturing facility - with 100-150 employees 20,705 Manufacturer or system and procedure pack producer or manufacturing facility - with 50-99 employees 15,530 Manufacturer or system and procedure pack producer or manufacturing facility - with 16-49 employees 5,175 Manufacturer or system and procedure pack producer or manufacturing facility - with 5-15 employees 1,295 Manufacturer or system and procedure pack producer or manufacturing facility - with less than 5 employees or annual turnover of less than €500,000 255 Authorised Representatives – annual fees Type I Authorised Representative – representing a non-EU manufacturer that manufactures low risk* devices (fee per manufacturer) 1,115 Type II Authorised Representative – representing a non- EU manufacturer that manufactures high risk** devices or a mix of high risk** & low risk* devices (fee per manufacturer) 1,520 Cap on type I Authorised Representative 5,575 Cap on type II Authorised Representative 7,600 (Note: * low risk devices means Class I general medical devices (as described in Council Directive 93/42/EEC of 14 June 19936 (‘MDD’) / the Medical Devices Regulation (‘MDR’)) and/or general category IVDs (as described in Directive 98/79/EC of the European Parliament and of the Council of 27 October 19982 (‘IVDD’)) / Class A (as described in the IVD Medical Devices Regulation (‘IVDR’).) (Note: ** high risk devices means Class IIa, IIb, III general medicinal devices (as described in MDD/MDR), active implantable medicinal devices, self-test IVD, Annex II IVD (as described in IVDD) or Class B, C and D (as described in IVDR).) Distributors and Importers – annual fees Large distributor/importer (turnover greater than €15 million) 4,660 Medium distributor/importer (turnover €3-€15 million) 2,590 Small distributor/importer (turnover under €3 million) 1,295 Distributor/importer turnover less than €500,000 255 Additional supplement – Entities acting as both a distributor and importer where turnover is more than €3 million 1,015 Notified Body – annual fees 5,175 Summary evaluation review fees Devices using starting materials for which a TSE certificate of suitability has been submitted 2,535 Devices using starting materials for which a TSE certificate of suitability has not been submitted 5,075 European Union Reference Laboratory (EURL) Application Verification 2,740 Certificate of free sale/letter confirming the location of the manufacturing facility in Ireland (4 certificates per request) 260 Each additional certificate of free sale/letter confirming the location of the manufacturing facility in Ireland – (available at time of request) 25 Letter confirming that a device or a list of devices are registered with the HPRA 120 Registration of Devices Online Registration – Administration fee 140 Clinical Investigations and IVDR performance studies Class III and Class IIb medical devices, including relevant MDR Annex XVI clinical investigations 4,365 Class IIa and Class I devices, including relevant MDR Annex 1,930 XVI clinical investigations Notifications and substantial modifications to notifications in accordance with MDR article 74

(1), Article 82, IVDR Article 58

(2)and IVDR Article 70

(1)205 Application for authorisation of in vitro diagnostic medical device (IVD) performance study under IVDR Article 58

(1)(first submission) and PMPF study under IVDR Article 70

(2)2,535 Substantial modifications and technical amendment to a previously approved clinical investigation/performance study 1,260 Resubmission of a clinical investigation/performance study following a withdrawal or objection or if the application has lapsed 1,930 Resubmission of a clinical investigation/performance study - Academic Sponsor 520 Determination of classification within the medical devices regulations Determination not requiring a complex technical review (one device per request) 285 Complex classification requests 1,035 MDR Article 51 / IVDR Article 47 referral 10,000 Appeal of a classification opinion 610 Designation Fee for a Notified Body Initial designation of a notified body and to the re-assessment of the notified body under the new Device Regulations 745 and 746 of 2017 10,355 Extensions to the scope (per extension) 5,175 Medicinal Product / Medical Device - Drug Consultation Fees New active substance 48,750 Established active in new therapeutic area 12,185 Established active and therapeutic area 7,070 Variations - Minor 1,025 Variations - Major 4,605 Assessments under Article 59 of the MDR and Article 54 of the IVDR Assessment fee 4,060 Miscellaneous - Medical Devices Search fee of medical devices data base 65 Daily charge-out rate for Technical Services 1,700 Hourly charge-out rate for Technical Services 270 Hourly charge-out rate for Administrative Services 80 Fees in relation to clinical trials under European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 ( S.I. No. 190 of 2004 ) Amendment to authorisation under Regulation 21 Notice of amendment 410 Notice of amendment to include a new investigational medicinal product dossier 880 Fees in relation to clinical trials under European Union (Clinical Trials on Medicinal Products for Human Use) (Principal) Regulations 2022 ( S.I. No. 99 of 2022 ) Applications with an investigational medicinal product dossier Mono National 3,420 Ireland – Reporting Member State 8,700 Ireland - Concerned Member State, initial, transitional or additional applications 3,200 Supplement – Where Ireland subsequently becomes the Reporting Member State 5,280 Reporting Member State – 2nd & subsequent waves 1,000 Applications with no investigational medicinal product dossier or with a simplified investigational medicinal product dossier Mono National 2,405 Ireland – Reporting Member State 7,500 Ireland - Concerned Member State, initial, transitional or additional applications 2,135 Supplement – Where Ireland subsequently becomes the Reporting Member State 5,095 Reporting Member State – 2nd & subsequent waves 1,000 Substantial Modifications (Parts I & II or Part I only) – with the addition of a new investigational medicinal product dossier Mono National 1,380 Ireland – Reporting Member State 1,600 Ireland - Concerned Member State 1,325 Substantial Modifications – other Mono National 910 Ireland – Reporting Member State 1,210 Ireland- Concerned Member State 830 Substantial Modifications – Part II only Substantial Modification 400 Fees for Appeals Appeal of clinical trial decision – Commercial 1,890 Fees for Safety Reports Review of Annual Safety reports/ Drug safety update reports 220 Fees for Inspections per day (per member of the inspection team) 1,850 per hour (per member of the inspection team) 265 Fees for applications in relation to Exemptions under Article 61

(5)of Regulation (EU) No. 536/2014 of the European Parliament and of the Council6 Registration fee 285 Amendment to registered details 155 GIVEN under my Official Seal, 21 December,

1. STEPHEN DONNELLY, 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 2022 ( S.I. No. 679 of 2022 ). These Regulations may be cited as the Health Products Regulatory Authority (Fees) Regulations
2. 1 OJ No. L 311, 28.11.2001, p.
3. 2 OJ No. L 117, 5.5.2017, p.
4. 3 OJ No. L 117, 5.5.2017, p.
5. 4 OJ No. L 169, 12.7.1993, p.
6. 5 OJ No. L 334, 12.12.2008, p.
7. 2 OJ No. L 117, 5.5.2017, p.
8. 6 OJ No. L 158, 27.5.2014, p.
9. 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