S.I. No. 744/2021 - Health Products Regulatory Authority (Fees) Regulations 2021

(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; “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)of the Medicinal Products (Control of Manufacture) Regulations 2007; “in vitro diagnostic medical device” has the meaning assigned to it by Article 2

(2)of the IVD Medical Devices Regulation or by Article 1

(2)(b) of Directive 98/79/EC of the European Parliament and of the Council of 27 October 19982 ; “IVD Medical Devices Regulation” means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 20173 ; “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 20174 , as amended by Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 20205 ; “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 19936 , 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 20087 ; “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 2020 ( S.I. No. 654 of 2020 ) are revoked. SCHEDULE COLUMN 1 COLUMN 2 Fees for national applications for marketing authorisations € Complex dossier National application 20,400 Each additional form (same time) 7,140 Each additional strength (same time) 1,020 Additional drug master file submitted 4,080 Reduced dossier – complex National application 15,300 Each additional form (same time) 7,140 Each additional strength (same time) 1,020 Additional drug master file submitted 4,080 Reduced dossier – standard National application 10,200 Each additional form (same time) 7,140 Each additional strength (same time) 1,020 Additional drug master file submitted 4,080 Subsequent extension applications First additional form 10,200 Each additional form (same time) 7,140 First additional strength (existing form) 3,060 Each additional strength (same time) 1,020 Additional drug master file submitted 4,080 Fees for applications for marketing authorisations using mutual recognition procedure and decentralised procedure Complex dossier Mutual recognition incoming 14,280 Each additional form (same time) 5,100 Each additional strength (same time) 1,020 Outgoing mutual recognition supplement 15,300 Outgoing mutual recognition supplement – mutual recognition applied for within twelve months of the national procedure ending 15,300 Decentralised incoming 20,400 Decentralised outgoing 51,000 Each additional form (same time) 7,140 Each additional strength (same time) 1,020 Additional supplement where there are 15 or more concerned Member States 1,530 Reduced dossier – complex Mutual recognition incoming 10,200 Each additional form (same time) 5,100 Each additional strength (same time) 1,020 Outgoing mutual recognition supplement 15,300 Outgoing mutual recognition supplement – mutual recognition applied for within twelve months of the national procedure ending 10,200 Decentralised incoming 15,300 Decentralised outgoing 40,800 Each additional form (same time) 7,140 Each additional strength (same time) 1,020 Additional supplement where there are 15 or more concerned Member States 1,530 Reduced dossier – standard Mutual recognition incoming 7,140 Each additional form (same time) 4,080 Each additional strength (same time) 1,020 Outgoing mutual recognition supplement 10,200 Outgoing mutual recognition supplement – mutual recognition applied for within twelve months of the national procedure ending 6,120 Decentralised incoming 10,200 Decentralised outgoing 26,520 Each additional form (same time) 7,140 Each additional strength (same time) 1,020 Additional supplement where there are 15 or more concerned Member States 1,530 Subsequent extension applications Mutual recognition incoming (first additional form) 7,140 Mutual recognition incoming (first additional strength) 2,040 Mutual recognition incoming (subsequent additional strength) 1,020 Outgoing mutual recognition/decentralised supplement (additional form) 3,060 Outgoing mutual recognition/decentralised supplement (additional strength) 1,020 Decentralised incoming (first additional form) 10,200 Decentralised outgoing (first additional form) 26,520 Each additional form (same time) 7,140 First additional strength (existing form) 3,060 Each additional strength (same time) 1,020 Additional supplement where there are 15 or more concerned Member States 1,530 Switching applications Switching applications 5,200 Fees for parallel import licences Application fee - per country at the same time or by variation 1,870 Each additional strength per country 555 Each additional form per country 555 Parallel imports - dual pack registration 935 Dual pack registration of parallel imports - each additional strength or form 555 Parallel imports where the originator is not on the Irish market 5,620 Change of ownership per product range 590 Fees for variations to national marketing authorisations Type IB variation 525 Type IB variation - reduced rate 265 Type II complex variation 2,920 Type II complex variation – reduced rate 570 Type II standard variation 570 Type II standard variation - reduced rate 285 Notifications under Article 61

(3)of Directive 2001/83/ EC 280 Notifications under Article 61

(3)of Directive 2001/83/EC - reduced rate 140 Multiple variations capped fee (per product range) 5,395 Multiple variations capped fee (per product) 3,485 Worksharing capped fee 5,845 Fees for variations to marketing authorisations under mutual recognition procedure and decentralised procedure Type IA variation outgoing mutual recognition / decentralised supplement 280 Type IB variation outgoing mutual recognition / decentralised supplement 390 Type IB variation - mutual recognition incoming 380 Type IB variation - mutual recognition incoming - reduced rate 195 Type II complex variation - outgoing mutual recognition / decentralised 590 Supplement Type II complex variation - mutual recognition incoming 2,020 Type II complex variation – mutual recognition incoming – reduced rate 380 Type II standard variation - mutual recognition incoming 380 Type II standard variation - mutual recognition incoming - reduced rate 195 Type II standard variation - outgoing mutual recognition / decentralised 380 Supplement Notifications made under Article 61

(3)of Directive 2001/83/EC 280 Notifications made under Article 61

(3)of Directive 2001/83/EC – reduced rate 140 Fees for the granting of a marketing authorisation on transfer to another company Change of ownership - related company – 1st marketing authorisation within a range 1,010 Change of ownership - related company – each additional marketing authorisation within a range 360 Change of ownership - non-related company – 1st marketing authorisation within a range 1,480 Change of ownership - non-related company – each additional marketing authorisation within a range 360 Other fees relating to the granting of marketing authorisations Service item 685 Notification to become a listed organisation Notification Fee 10 Fees for applications for wholesaler’s authorisations Application fee 625 Variation to authorisation - minor site technical 450 Variation to authorisation – administrative 245 Variation to authorisation – technical 675 Fees for applications for manufacturer’s authorisations Application fee 2,080 Variation to authorisation – administrative 310 Variation to authorisation – technical 865 Variation to authorisation – fast track 1,225 Fees for applications in relation to brokers register and active substances register Registration fee – importers and distributors of active substances and brokers 280 Registration fee – manufacturers of active substances 495 Immediate notification of a change which may impact on the quality or safety of the active substances 865 Notification of an administrative change to the active substances register 155 Notification of any change to the brokers register 155 Fees for applications for organ establishment authorisations Application charge 2,080 Variation to authorisation – administrative 310 Variation to authorisation – technical 865 Appeal to amend/revoke an authorisation 560 Scientific opinion on the non-viability of the cells/tissue, donation, procurement testing 3,000 Fees for transferring of authorisation/registration to another company Manufacturer’s authorisation and organ establishment authorisation 1,245 Related company Unrelated company 2,080 Wholesaler’s authorisation, registration on brokers register and registration on active substances register Related company 410 Unrelated company 625 Fees for applications in relation to cosmetic products Certificates of free sale – standard (4 certificates per request) 165 Certificates of free sale – fast track (4 certificates per request) 310 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 760 New national / decentralised registration standard charge - 2 or more stocks 1,140 New application - national rules scheme standard fee - single stock 1,140 New application - national rules scheme standard fee - 2 or more stocks 1,685 Mutual recognition incoming application standard fee - single stock 510 Mutual recognition incoming application standard fee - 2 or more stocks 760 Outgoing mutual recognition / decentralised supplement 635 National variation – registration and national rules scheme 380 National variation – reduced rate – registrations and national rules scheme 190 Mutual recognition incoming variation 255 Mutual recognition incoming variation - reduced rate 125 Variation – outgoing mutual recognition / decentralised supplement 190 Bulk variation for multiple changes to the Masterfile 2,290 Fees for applications in relation to traditional herbal medicinal products National applications for certificates of traditional-use registration National application 5,495 National application where there is a monograph 3,370 Each additional form (same time) 4,575 Each additional strength (same time) 590 Additional drug master file submitted 3,655 Extension applications First additional form 5,495 Each additional form (same time) 4,575 First additional strength 2,480 Each additional strength (same time) 590 Applications for certificates of traditional-use registration under mutual recognition procedure and decentralised procedure Mutual recognition incoming 3,840 Mutual recognition incoming - each additional form (same time) 2,570 Mutual recognition incoming - each additional strength (same time) 590 Outgoing mutual recognition / decentralised supplement 4,995 Decentralised outgoing/incoming 5,495 Each additional form (same time) 4,575 Each additional strength (same time) 590 Traditional herbal medicinal products – national variations Type IB variation – national 420 Type IB variation – reduced rate 215 Type II standard variation 450 Type II standard variation – reduced rate 225 Type II complex variation 2,360 Bulk variation for multiple changes 4,720 Traditional herbal medicinal products – mutual recognition variations Type IB variation – mutual recognition incoming 305 Type IB variation – mutual recognition incoming - reduced rate 155 Type IB variation – outgoing mutual recognition supplement 310 Type II standard – mutual recognition incoming 305 Type II standard – mutual recognition incoming - reduced rate 155 Type II standard – outgoing mutual recognition supplement 305 Type II complex – mutual recognition incoming 1,615 Type II complex – outgoing mutual recognition supplement 470 Fees for export certificates and certification of documents Standard 165 Fast track 310 Annual maintenance fees Marketing authorisations and registrations First 10 marketing authorisations 730 Additional marketing authorisation 910 Dormant marketing authorisation 463 Parallel import licence 125 Parallel import licence - Dual pack 60 Certificate of registration - homeopathic medicinal products 60 Certificate of traditional-use registration - traditional herbal medicinal products 125 Manufacturer’s authorisations Major site (more than 250 employees) 22,000 Large site (150-250 employees) 15,000 Medium site (50-149 employees) 10,000 Small site (less than 50 employees) 4,500 Homeopathic manufacturing site 1,125 Wholesaler’s authorisations Large full line 3,115 Medium full line / short line 1,770 Small short line 675 Minor site / Procure & supply 450 Active substances register Active substances distributor 280 Active substances importer 560 Active substances manufacturer 1,125 Organ establishment authorisations Major establishment (more than 250 employees) 18,730 Large establishment (150-250 employees) 12,485 Medium establishment (50-149 employees) 8,325 Small establishment (less than 50 employees) 4,160 Minor establishment (less than 5 employees) 1,125 Fees in relation to protection of animals used for scientific purposes Project fees Project application without ethical approval 2,100 Fast track project application 2,100 Breeder/Supplier/User Authorisation fees Band 1: Small establishment with no animal facilities or establishment with 1-3 individual authorisation holders 305 Band 2: Establishment with 4-10 individual authorisation holders 605 Band 3: Establishment with 11-20 individual authorisation holders 935 Band 4: Establishment with 21-50 individual authorisation holders 1,760 Band 5: Establishment with 51-100 individual authorisation holders 3,575 Band 6: Establishment with 101-150 individual authorisation holders 6,050 Band 7: Establishment with 151 – 200 individual authorisation holders 8,800 Band 8: Establishment with >201 individual authorisation holders 11,550 Individual authorisation fees Application fee 295 Annual fee 295 Once-off authorisation - procedural training for a period of two months or less (reduced fee) 100 Fees for follow-up inspections Per day (per member of the inspection team) 1,675 Part of day (per hour, per member of the inspection team) 240 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) 1,675 Part of day (per hour, per member of the inspection team) 240 Inspection cancellation/rescheduling fee 500 Enforcement fees Manufacturers Major site (more than 250 employees) 2,695 Large site (150-250 employees) 2,025 Medium site (50-149 employees) 675 Small site (less than 50 employees) 225 Wholesalers Large full line 675 Medium full line / short line 225 Marketing authorisation / parallel import licence holders > 50 marketing authorisations / parallel import licences 3,540 31-50 marketing authorisations / parallel import licences 1,125 16-30 marketing authorisations / parallel import licences 675 6-15 marketing authorisations / parallel import licences 225 (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 30,600 Manufacturer or system and procedure pack producer or manufacturing facility - with 100-150 employees 20,400 Manufacturer or system and procedure pack producer or manufacturing facility - with 50-99 employees 15,300 Manufacturer or system and procedure pack producer or manufacturing facility - with 16-49 employees 5,100 Manufacturer or system and procedure pack producer or manufacturing facility - with 5-15 employees 1,275 Manufacturer or system and procedure pack producer or manufacturing facility - with less than 5 employees or annual turnover of less than €500,000 250 Authorised Representatives – annual fees Type I Authorised Representative – representing a non-EU manufacturer that manufactures low risk* devices (fee per manufacturer) 1,100 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) 1,500 Cap on type I Authorised Representative 5,500 Cap on type II Authorised Representative 7,500 (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) 4,590 Medium distributor/importer (turnover €3-€15 million) 2,550 Small distributor/importer (turnover under €3 million) 1,275 Distributor/importer turnover less than €500,000 250 Additional supplement – Entities acting as both a distributor and importer where turnover is more than €500,000 1,000 Additional supplement – Entities acting as both a distributor and importer where turnover is less than €500,000 250 Notified Body – annual fees 5,100 Summary evaluation review fees Devices using starting materials for which a TSE certificate of suitability has been submitted 2,500 Devices using starting materials for which a TSE certificate of suitability has not been submitted 5,000 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) 255 Each additional certificate of free sale/letter confirming the location of the manufacturing facility in Ireland – (available at time of request) 25 GIVEN under my Official Seal, 21 December, 2021. 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 2020 ( S.I. No. 654 of 2020 ). These Regulations may be cited as the Health Products Regulatory Authority (Fees) Regulations 2021. 1 OJ No. L 311, 28.11.2001, p. 67. 2 OJ No. L 331, 7.12.1998, p. 1 3 OJ No. L 117, 5.5.2017, p. 176. 4 OJ No. L 117, 5.5.2017, p. 1. 5 OJ No. L 130, 24.4.2020, p. 18. 6 OJ No. L 169, 12.7.1993, p. 1. 7 OJ No. L 334, 12.12.2008, p. 7. 6 OJ No. L 169, 12.7.1993, p. 1. 2 OJ No. L 331, 7.12.1998, p. 1 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