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

1. These Regulations may be cited as the Health Products Regulatory Authority (Fees) Regulations 2024.

2. In these Regulations—

“Act of 1995” means the

Irish Medicines Board Act 1995

(No. 29 of 1995);

“Act of 2006” means the

Irish Medicines Board (Miscellaneous Provisions) Act 2006

(No. 3 of 2006);

“active substances register” has the meaning assigned to it by Regulation 3(1) (inserted by Regulation 3(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—

(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(a) of the Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013) of the Control of Wholesale Distribution Regulations;

“certificate of free sale” means –

(a) a certificate of free sale issued under section 4(1)(k)(ii) (as amended by section 11(a)(iii) of the Act of 2006) of the Act of 1995,

(b) a certificate of free sale issued under Article 60 of the Medical Devices Regulation, or

(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)(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 –

(a) a medical device,

(b) an accessory for a medical device,

(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,

(d) an

in vitro

diagnostic medical device, or

(e) an accessory for an

in vitro

diagnostic medical device,

but does not include-

(i) a product or other substance excluded by Article 1(6)(b) to

(i) of the Medical Devices Regulation,

(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 2001

1

;

“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(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—

(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 2017

2

;

“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—

(a) manufactures a device,

(b) manufactures one or more critical components of a device to a set of specifications,

(c) carries out packaging activities in relation to a device, or

(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—

(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 2017

3

;

“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 1993

4

, 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 2008

5

;

“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 2007.

3. 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.

4. 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 3.

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 – 1

st

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 – 1

st

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 1993

4

(‘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 1998

6

(‘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 – 2

nd

& 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 – 2

nd

& 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 Council

7

Registration fee

300

Amendment to registered details

165

GIVEN under the Official Seal of the Minister for Health,

23 December, 2024.

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 2024.

1 OJ No. L 311, 28.11.2001, p. 67.

2 OJ No. L 117, 5.5.2017, p. 176.

3 OJ No. L 117, 5.5.2017, p. 1.

4 OJ No. L 169, 12.7.1993, p. 1.

5 OJ No. L 334, 12.12.2008, p. 7.

4 OJ No. L 169, 12.7.1993, p. 1.

6 OJ No. L 331, 7.12.1998, p. 1.

7 OJ No. L 158, 27.5.2014, p. 1.

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

7

th January,

2025.

The Minister for Health, in exercise of the powers conferred on him by sections

13

and

32

(as amended by

sections 15

and

16

of the

Irish Medicines Board (Miscellaneous Provisions) Act 2006

(No. 3 of 2006)) of the

Irish Medicines Board Act 1995

(No. 29 of 1995), hereby make the following regulations