S.I. No. 751/2024 - Health Products Regulatory Authority (Fees) Regulations 2024

(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) 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 2023 ( S.I. No. 697 of 2023 ) are revoked. SCHEDULE COLUMN 1 COLUMN 2 Fees for national applications for marketing authorisations€ Complex dossier National application 23,700 Each additional form (same time) 8,295 Each additional strength (same time) 1,180 Additional drug master file submitted 4,735 Reduced dossier – complex National application 17,770 Each additional form (same time) 8,295 Each additional strength (same time) 1,180 Additional drug master file submitted 4,735 Reduced dossier – standard National application 11,850 Each additional form (same time) 8,295 Each additional strength (same time) 1,180 Additional drug master file submitted 4,735 Subsequent extension applications First additional form 11,850 Each additional form (same time) 8,295 First additional strength (existing form) 3,555 Each additional strength (same time) 1,180 Additional drug master file submitted 4,735 Fees for applications for marketing authorisations using mutual recognition procedure and decentralised procedure Complex dossier Mutual recognition incoming 16,590 Each additional form (same time) 5,925 Each additional strength (same time) 1,180 Outgoing mutual recognition supplement 17,770 Outgoing mutual recognition supplement – mutual recognition applied for within twelve months of the national procedure ending 17,770 Decentralised incoming 23,700 Decentralised outgoing 59,245 Each additional form (same time) 8,295 Each additional strength (same time) 1,180 Additional supplement where there are 15 or more concerned Member States 1,780 Reduced dossier – complex Mutual recognition incoming 11,850 Each additional form (same time) 5,925 Each additional strength (same time) 1,180 Outgoing mutual recognition supplement 17,770 Outgoing mutual recognition supplement – mutual recognition applied for within twelve months of the national procedure ending 11,850 Decentralised incoming 17,770 Decentralised outgoing 47,390 Each additional form (same time) 8,295 Each additional strength (same time) 1,180 Additional supplement where there are 15 or more concerned Member States 1,780 Reduced dossier – standard Mutual recognition incoming 8,295 Each additional form (same time) 4,735 Each additional strength (same time) 1,180 Outgoing mutual recognition supplement 11,850 Outgoing mutual recognition supplement – mutual recognition applied for within twelve months of the national procedure ending 7,110 Decentralised incoming 11,850 Decentralised outgoing 30,805 Each additional form (same time) 8,295 Each additional strength (same time) 1,180 Additional supplement where there are 15 or more concerned Member States 1,780 Subsequent extension applications Mutual recognition incoming (first additional form) 8,295 Mutual recognition incoming (first additional strength) 2,375 Mutual recognition incoming (subsequent additional strength) 1,180 Outgoing mutual recognition/decentralised supplement (additional form) 3,555 Outgoing mutual recognition/decentralised supplement (additional strength) 1,180 Decentralised incoming (first additional form) 11,850 Decentralised outgoing (first additional form) 30,805 Each additional form (same time) 8,295 First additional strength incoming (existing form) 3,555 First additional strength outgoing (existing form) 8,295 Each additional strength (same time) 1,180 Additional supplement where there are 15 or more concerned Member States 1,780 Switching applications Switching applications 6,045 Fees for parallel import licences Application fee - per country at the same time or by variation 2,175 Each additional strength per country 645 Each additional form per country 645 Parallel imports - dual pack registration 1,085 Dual pack registration of parallel imports - each additional strength or form 645 Parallel imports where the originator is not on the Irish market 6,525 Change of ownership per product range 690 Fees for variations to national marketing authorisations Type IB variation 610 Type IB variation - reduced rate 310 Type II complex variation 3,395 Type II complex variation – reduced rate 660 Type II standard variation 660 Type II standard variation - reduced rate 330 Notifications under Article 61

(3)of Directive 2001/83/ EC 325 Notifications under Article 61

(3)of Directive 2001/83/EC - reduced rate 165 Multiple variations capped fee (per product range) 6,270 Multiple variations capped fee (per product) 4,050 Worksharing capped fee 6,790 Fees for variations to marketing authorisations under mutual recognition procedure and decentralised procedure Type IA variation outgoing mutual recognition / decentralised supplement 325 Type IB variation outgoing mutual recognition / decentralised supplement 450 Type IB variation - mutual recognition incoming 440 Type IB variation - mutual recognition incoming - reduced rate 230 Type II complex variation - outgoing mutual recognition / decentralised supplement 690 Type II complex variation - mutual recognition incoming 2,345 Type II complex variation – mutual recognition incoming – reduced rate 440 Type II standard variation - mutual recognition incoming 440 Type II standard variation - mutual recognition incoming - reduced rate 230 Type II standard variation - outgoing mutual recognition / decentralised supplement 440 Notifications made under Article 61

(3)of Directive 2001/83/EC 325 Notifications made under Article 61

(3)of Directive 2001/83/EC – reduced rate 165 Fees for the granting of a marketing authorisation on transfer to another company Change of ownership - related company – 1st marketing authorisation within a range 1,170 Change of ownership - related company – each additional marketing authorisation within a range 415 Change of ownership - non-related company – 1st marketing authorisation within a range 1,720 Change of ownership - non-related company – each additional marketing authorisation within a range 415 Other fees relating to the granting of marketing authorisations Service item 795 Notification to become a listed organisation Notification Fee 10 Fees for applications for wholesaler’s authorisations Application fee 725 Variation to authorisation - minor site technical 520 Variation to authorisation – administrative 285 Variation to authorisation – technical 780 Fees for applications for manufacturer’s authorisations Application fee 2,415 Variation to authorisation – administrative 360 Variation to authorisation – technical 1,010 Variation to authorisation – fast track 1,425 Fees for applications in relation to brokers register and active substances register Registration fee – importers and distributors of active substances and brokers 325 Registration fee – manufacturers of active substances 580 Immediate notification of a change which may impact on the quality or safety of the active substances 1,010 Notification of an administrative change to the active substances register 185 Notification of any change to the brokers register 185 Fees for applications for organ establishment authorisations Application charge 2,415 Variation to authorisation – administrative 360 Variation to authorisation – technical 1,010 Appeal to amend/revoke an authorisation 650 Scientific opinion on the non-viability of the cells/tissue, donation, procurement testing 3,485 Fees for transferring of authorisation/registration to another company Manufacturer’s authorisation and organ establishment authorisation Related company 1,445 Unrelated company 2,415 Wholesaler’s authorisation, registration on brokers register and registration on active substances register Related company 475 Unrelated company 725 Fees for applications in relation to cosmetic products Certificates of free sale – standard (4 certificates per request) 195 Certificates of free sale – fast track (4 certificates per request) 360 Duplicate certificates of free sale – each (available at time of initial request) 25 Fees for applications in relation to homeopathic medicinal products New national / decentralised registration standard charge - single stock 880 New national / decentralised registration standard charge - 2 or more stocks 1,330 New application - national rules scheme standard fee - single stock 1,330 New application - national rules scheme standard fee - 2 or more stocks 1,960 Mutual recognition incoming application standard fee - single stock 595 Mutual recognition incoming application standard fee - 2 or more stocks 880 Outgoing mutual recognition / decentralised supplement 735 National variation – registration and national rules scheme 440 National variation – reduced rate – registrations and national rules scheme 220 Mutual recognition incoming variation 300 Mutual recognition incoming variation - reduced rate 140 Variation – outgoing mutual recognition / decentralised supplement 220 Bulk variation for multiple changes to the Masterfile 2,655 Fees for applications in relation to traditional herbal medicinal products National applications for certificates of traditional-use registration National application 6,385 National application where there is a monograph 3,915 Each additional form (same time) 5,315 Each additional strength (same time) 690 Additional drug master file submitted 4,245 Extension applications First additional form 6,385 Each additional form (same time) 5,315 First additional strength 2,880 Each additional strength (same time) 690 Applications for certificates of traditional-use registration under mutual recognition procedure and decentralised procedure Mutual recognition incoming 4,465 Mutual recognition incoming - each additional form (same time) 2,980 Mutual recognition incoming - each additional strength (same time) 690 Outgoing mutual recognition / decentralised supplement 5,800 Decentralised outgoing/incoming 6,385 Each additional form (same time) 5,315 Each additional strength (same time) 690 Traditional herbal medicinal products – national variations Type IB variation – national 490 Type IB variation – reduced rate 250 Type II standard variation 520 Type II standard variation – reduced rate 265 Type II complex variation 2,740 Bulk variation for multiple changes 5,480 Traditional herbal medicinal products – mutual recognition variations Type IB variation – mutual recognition incoming 350 Type IB variation – mutual recognition incoming - reduced rate 185 Type IB variation – outgoing mutual recognition supplement 360 Type II standard – mutual recognition incoming 350 Type II standard – mutual recognition incoming - reduced rate 185 Type II standard – outgoing mutual recognition supplement 350 Type II complex – mutual recognition incoming 1,875 Type II complex – outgoing mutual recognition supplement 545 Fees for export certificates and certification of documents Standard 195 Fast track 360 Annual maintenance fees Marketing authorisations and registrations First 10 marketing authorisations 845 Additional marketing authorisation 1,055 Dormant marketing authorisation 463 Parallel import licence 140 Parallel import licence - Dual pack 70 Certificate of registration - homeopathic medicinal products 70 Certificate of traditional-use registration - traditional herbal medicinal products 140 Manufacturer’s authorisations Major site (more than 250 employees) 25,555 Large site (150-250 employees) 17,425 Medium site (50-149 employees) 11,620 Small site (less than 50 employees) 5,230 Homeopathic manufacturing site 1,305 Wholesaler’s authorisations Large full line 3,615 Medium full line / short line 2,060 Small short line 780 Minor site / Procure & supply 520 Active substances register Active substances distributor 325 Active substances importer 650 Active substances manufacturer 1,305 Organ establishment authorisations Major establishment (more than 250 employees) 21,755 Large establishment (150-250 employees) 14,505 Medium establishment (50-149 employees) 9,670 Small establishment (less than 50 employees) 4,835 Minor establishment (less than 5 employees) 1,305 Fees in relation to protection of animals used for scientific purposes Project authorisation fees Project application without ethical approval 2,385 Fast track project application 2,385 Fast track evaluation of project amendment application 750 Breeder/Supplier/User Authorisation fees Band 1: Small establishment with no animal facilities or establishment with 1-3 individual authorisation holders 345 Band 2: Establishment with 4-10 individual authorisation holders 690 Band 3: Establishment with 11-20 individual authorisation holders 1,055 Band 4: Establishment with 21-40 individual authorisation holders 1,995 Band 5: Establishment with 41-70 individual authorisation holders 3,035 Band 6: Establishment with 71-100 individual authorisation holders 4,055 Band 7: Establishment with 101-150 individual authorisation holders 6,855 Band 8: Establishment with 151-200 individual authorisation holders 9,975 Band 9: Establishment with >200 individual authorisation holders 13,095 Individual authorisation fees Application fee 335 Annual fee 335 Once-off authorisation - procedural training for a period of two months or less (reduced fee) 115 Fees for follow-up inspections Per day (per member of the inspection team) 1,945 Part of day (per hour, per member of the inspection team) 280 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) 1,945 Part of day (per hour, per member of the inspection team) 280 Inspection cancellation/rescheduling fee 530 Enforcement fees Manufacturers Major site (more than 250 employees) 3,135 Large site (150-250 employees) 2,350 Medium site (50-149 employees) 780 Small site (less than 50 employees) 265 Wholesalers Large full line 780 Medium full line / short line 265 Marketing authorisation / parallel import licence holders > 50 marketing authorisations / parallel import licences 4,115 31-50 marketing authorisations / parallel import licences 1,305 16-30 marketing authorisations / parallel import licences 780 6-15 marketing authorisations / parallel import licences 265 (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 32,615 Manufacturer or system and procedure pack producer or manufacturing facility - with 100-150 employees 21,740 Manufacturer or system and procedure pack producer or manufacturing facility - with 50-99 employees 16,305 Manufacturer or system and procedure pack producer or manufacturing facility - with 16-49 employees 5,435 Manufacturer or system and procedure pack producer or manufacturing facility - with 5-15 employees 1,360 Manufacturer or system and procedure pack producer or manufacturing facility - with less than 5 employees or annual turnover of less than €500,000 270 Authorised Representatives – annual fees Type I Authorised Representative – representing a non-EU manufacturer that manufactures low risk* devices (fee per manufacturer) 1,170 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) 1,595 Cap on type I Authorised Representative 5,850 Cap on type II Authorised Representative 7,975 (Note: * low risk devices means Class I general medical devices (as described in Council Directive 93/42/EEC of 14 June 19934 (‘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 19986 (‘IVDD’)) / Class A (as described in the IVD Medical Devices Regulation (‘IVDR’).) (Note: ** high risk devices means Class IIa, IIb, III general medical devices (as described in MDD/MDR), active implantable medical 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) 4,895 Medium distributor/importer (turnover €3-€15 million) 2,720 Small distributor/importer (turnover under €3 million) 1,360 Distributor/importer turnover less than €500,000 270 Additional supplement – Entities acting as both a distributor and importer where turnover is more than €3 million 1,065 Notified Body – annual fees 5,435 Summary evaluation review fees Devices using starting materials for which a TSE certificate of suitability has been submitted 2,660 Devices using starting materials for which a TSE certificate of suitability has not been submitted 5,330 European Union Reference Laboratories European Union Reference Laboratory (EURL) Application Verification 2,875 Certificates of free sale or letters confirming the location of the manufacturing facility in Ireland for Devices Certificate of free sale/letter confirming the location of the manufacturing facility in Ireland (4 certificates per request) 275 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 125 Registration of Devices Online Registration – Administration fee 145 Clinical Investigations and IVDR performance studies Class III and Class IIb medical devices, including relevant MDR 4,585 Annex XVI clinical investigations Class IIa and Class I devices, including relevant MDR Annex 2,025 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)215 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)2,660 Substantial modifications and technical amendment to a previously approved clinical investigation/performance study 1,325 Resubmission of a clinical investigation/performance study following a withdrawal or objection or if the application has lapsed 2,025 Resubmission of a clinical investigation/performance study - Academic Sponsor 545 Determination of classification within the medical devices regulations Determination not requiring a complex technical review (one device per request) 300 Complex classification requests 1,085 MDR Article 51 / IVDR Article 47 referral 10,500 Appeal of a classification opinion 640 Designation Fee for a Notified Body Initial designation of a notified body and to the re-assessment of the notified body under the IVD Medical Devices Regulation and the Medical Devices Regulation 10,875 Extensions to the scope (per extension) 5,435 Medicinal Product / Medical Device - Drug Consultation Fees New active substance 51,190 Established active in new therapeutic area 12,795 Established active and therapeutic area 7,425 Variations - Minor 1,075 Variations - Major 4,835 Assessments under Article 59 of the MDR and Article 54 of the IVDR Assessment fee 4,265 Miscellaneous - Medical Devices Daily charge-out rate for Technical Services 1,785 Hourly charge-out rate for Technical Services 285 Hourly charge-out rate for Administrative Services 85 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 3,610 Ireland – Reporting Member State 9,035 Ireland - Concerned Member State, initial, transitional or additional applications 3,370 Supplement – Where Ireland subsequently becomes the Reporting Member State 5,520 Reporting Member State – 2nd & subsequent waves 1,025 Applications with no investigational medicinal product dossier or with a simplified investigational medicinal product dossier Mono National 2,495 Ireland – Reporting Member State 7,775 Ireland - Concerned Member State, initial, transitional or additional applications 2,220 Supplement – Where Ireland subsequently becomes the Reporting Member State 5,325 Reporting Member State – 2nd & subsequent waves 1,025 Substantial Modifications (Parts I & II or Part I only) – with the addition of a new investigational medicinal product dossier Mono National 1,480 Ireland – Reporting Member State 1,720 Ireland - Concerned Member State 1,420 Substantial Modifications – other Mono National 960 Ireland – Reporting Member State 1,290 Ireland- Concerned Member State 875 Substantial Modifications – Part II only Substantial Modification 400 Fees for Appeals Appeal of clinical trial decision – Commercial 1,925 Fees for Inspections per day (per member of the inspection team) 1,945 per hour (per member of the inspection team) 280 Fees for applications in relation to Exemptions under Article 61

(5)of Regulation (EU) No. 536/2014 of the European Parliament and of the Council7 Registration fee 300 Amendment to registered details 165 GIVEN under the Official Seal of the Minister for Health, 23 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 2023 ( S.I. No. 697 of 2023 ). 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. 4 OJ No. L 169, 12.7.1993, p.
8. 6 OJ No. L 331, 7.12.1998, p.
9. 7 OJ No. L 158, 27.5.2014, p.
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