S.I. No. 679/2022 - Health Products Regulatory Authority (Fees) Regulations 2022

1. These Regulations may be cited as the Health Products Regulatory Authority (Fees) Regulations 2022.

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) 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

as amended by Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022;

“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-

(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

, as amended by Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020

4

“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

5

,

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

6

;

“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 2021 (

S.I. No. 744 of 2021

) are revoked.

SCHEDULE

COLUMN 1

COLUMN 2

Fees for national applications for marketing authorisations

€

Complex dossier

National application

22,235

Each additional form (same time)

7,785

Each additional strength (same time)

1,110

Additional drug master file submitted

4,445

Reduced dossier - complex

National application

16,675

Each additional form (same time)

7,785

Each additional strength (same time)

1,110

Additional drug master file submitted

4,445

Reduced dossier - standard

National application

11,120

Each additional form (same time)

7,785

Each additional strength (same time)

1,110

Additional drug master file submitted

4,445

Subsequent extension applications

First additional form

11,120

Each additional form (same time)

7,785

First additional strength (existing form)

3,335

Each additional strength (same time)

1,110

Additional drug master file submitted

4,445

Fees for applications for marketing authorisations using mutual recognition procedure and decentralised procedure

Complex dossier

Mutual recognition incoming

15,565

Each additional form (same time)

5,560

Each additional strength (same time)

1,110

Outgoing mutual recognition supplement

16,675

Outgoing mutual recognition supplement - mutual recognition applied for within twelve months of the national procedure ending

16,675

Decentralised incoming

22,235

Decentralised outgoing

55,590

Each additional form (same time)

7,785

Each additional strength (same time)

1,110

Additional supplement where there are 15 or more concerned Member States

1,670

Reduced dossier - complex

Mutual recognition incoming

11,120

Each additional form (same time)

5,560

Each additional strength (same time)

1,110

Outgoing mutual recognition supplement

16,675

Outgoing mutual recognition supplement - mutual recognition applied for within twelve months of the national procedure ending

11,120

Decentralised incoming

16,675

Decentralised outgoing

44,470

Each additional form (same time)

7,785

Each additional strength (same time)

1,110

Additional supplement where there are 15 or more concerned Member States

1,670

Reduced dossier - standard

Mutual recognition incoming

7,785

Each additional form (same time)

4,445

Each additional strength (same time)

1,110

Outgoing mutual recognition supplement

11,120

Outgoing mutual recognition supplement - mutual recognition applied for within twelve months of the national procedure ending

6,670

Decentralised incoming

11,120

Decentralised outgoing

28,905

Each additional form (same time)

7,785

Each additional strength (same time)

1,110

Additional supplement where there are 15 or more concerned Member States

1,670

Subsequent extension applications

Mutual recognition incoming (first additional form)

7,785

Mutual recognition incoming (first additional strength)

2,225

Mutual recognition incoming (subsequent additional strength)

1,110

Outgoing mutual recognition/decentralised supplement (additional form)

3,335

Outgoing mutual recognition/decentralised supplement (additional strength)

1,110

Decentralised incoming (first additional form)

11,120

Decentralised outgoing (first additional form)

28,905

Each additional form (same time)

7,785

First additional strength (existing form)

3,335

Each additional strength (same time)

1,110

Additional supplement where there are 15 or more concerned Member States

1,670

Switching applications

Switching applications

5,670

Fees for parallel import licences

Application fee - per country at the same time or by variation

2,040

Each additional strength per country

605

Each additional form per country

605

Parallel imports - dual pack registration

1,020

Dual pack registration of parallel imports - each additional strength or form

605

Parallel imports where the originator is not on the Irish market

6,125

Change of ownership per product range

645

Fees for variations to national marketing authorisations

Type IB variation

570

Type IB variation - reduced rate

290

Type II complex variation

3,185

Type II complex variation - reduced rate

620

Type II standard variation

620

Type II standard variation - reduced rate

310

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

305

Notifications under Article 61(3) of Directive 2001/83/EC - reduced rate

155

Multiple variations capped fee (per product range)

5,880

Multiple variations capped fee (per product)

3,800

Worksharing capped fee

6,370

Fees for variations to marketing authorisations under mutual recognition procedure and decentralised procedure

Type IA variation outgoing mutual recognition / decentralised supplement

305

Type IB variation outgoing mutual recognition / decentralised supplement

425

Type IB variation - mutual recognition incoming

415

Type IB variation - mutual recognition incoming - reduced rate

215

Type II complex variation - outgoing mutual recognition / decentralised

645

Supplement

Type II complex variation - mutual recognition incoming

2,200

Type II complex variation - mutual recognition incoming - reduced rate

415

Type II standard variation - mutual recognition incoming

415

Type II standard variation - mutual recognition incoming - reduced rate

215

Type II standard variation - outgoing mutual recognition / decentralised

415

Supplement

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

305

Notifications made under Article 61(3) of Directive 2001/83/EC - reduced rate

155

Fees for the granting of a marketing authorisation on transfer to another company

Change of ownership - related company - 1

st

marketing authorisation within a range

1,100

Change of ownership - related company - each additional marketing authorisation within a range

390

Change of ownership - non-related company - 1

st

marketing authorisation within a range

1,615

Change of ownership - non-related company - each additional marketing authorisation within a range

390

Other fees relating to the granting of marketing authorisations

Service item

745

Notification to become a listed organisation

Notification Fee

10

Fees for applications for wholesaler’s authorisations

Application fee

680

Variation to authorisation - minor site technical

490

Variation to authorisation - administrative

265

Variation to authorisation - technical

735

Application fee

2,265

Variation to authorisation - administrative

340

Variation to authorisation - technical

945

Variation to authorisation - fast track

1,335

Fees for applications for manufacturer’s authorisations

Fees for applications in relation to brokers register and active substances register

Registration fee - importers and distributors of active substances and brokers

305

Registration fee - manufacturers of active substances

540

Immediate notification of a change which may impact on the quality or safety of the active substances

945

Notification of an administrative change to the active substances register

170

Notification of any change to the brokers register

170

Fees for applications for organ establishment authorisations

Application charge

2,265

Variation to authorisation - administrative

340

Variation to authorisation - technical

945

Appeal to amend/revoke an authorisation

610

Scientific opinion on the non-viability of the cells/tissue, donation, procurement testing

3,270

Fees for transferring of authorisation/registration to another company

Manufacturer’s authorisation and organ establishment authorisation

Related company

1,355

Unrelated company

2,265

Wholesaler’s authorisation, registration on brokers register and registration on active substances register

Related company

445

Unrelated company

680

Fees for applications in relation to cosmetic products

Certificates of free sale - standard (4 certificates per request)

180

Certificates of free sale - fast track (4 certificates per request)

340

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

830

New national / decentralised registration standard charge - 2 or more stocks

1,245

New application - national rules scheme standard fee - single stock

1,245

New application - national rules scheme standard fee - 2 or more stocks

1,835

Mutual recognition incoming application standard fee - single stock

555

Mutual recognition incoming application standard fee - 2 or more stocks

830

Outgoing mutual recognition / decentralised supplement

690

National variation - registration and national rules scheme

415

National variation - reduced rate - registrations and national rules scheme

205

Mutual recognition incoming variation

280

Mutual recognition incoming variation - reduced rate

135

Variation - outgoing mutual recognition / decentralised supplement

205

Bulk variation for multiple changes to the Masterfile

2,495

Fees for applications in relation to traditional herbal medicinal products

National applications for certificates of traditional-use registration

National application

5,990

National application where there is a monograph

3,675

Each additional form (same time)

4,985

Each additional strength (same time)

645

Additional drug master file submitted

3,985

Extension applications

First additional form

5,990

Each additional form (same time)

4,985

First additional strength

2,705

Each additional strength (same time)

645

Applications for certificates of traditional-use registration under mutual recognition procedure and decentralised procedure

Mutual recognition incoming

4,185

Mutual recognition incoming - each additional form (same time)

2,800

Mutual recognition incoming - each additional strength (same time)

645

Outgoing mutual recognition / decentralised supplement

5,445

Decentralised outgoing/incoming

5,990

Each additional form (same time)

4,985

Each additional strength (same time)

645

Traditional herbal medicinal products - national variations

Type IB variation - national

460

Type IB variation - reduced rate

235

Type II standard variation

490

Type II standard variation - reduced rate

245

Type II complex variation

2,570

Bulk variation for multiple changes

5,145

Traditional herbal medicinal products - mutual recognition variations

Type IB variation - mutual recognition incoming

330

Type IB variation - mutual recognition incoming - reduced rate

170

Type IB variation - outgoing mutual recognition supplement

340

Type II standard - mutual recognition incoming

330

Type II standard - mutual recognition incoming - reduced rate

170

Type II standard - outgoing mutual recognition supplement

330

Type II complex - mutual recognition incoming

1,760

Type II complex - outgoing mutual recognition supplement

510

Fees for export certificates and certification of documents

Standard

180

Fast track

340

Annual maintenance fees

Marketing authorisations and registrations

First 10 marketing authorisations

795

Additional marketing authorisation

990

Dormant marketing authorisation

463

Parallel import licence

135

Parallel import licence - Dual pack

65

Certificate of registration - homeopathic medicinal products

65

Certificate of traditional-use registration - traditional herbal medicinal products

135

Manufacturer’s authorisations

Major site (more than 250 employees)

23,980

Large site (150-250 employees)

16,350

Medium site (50-149 employees)

10,900

Small site (less than 50 employees)

4,905

Homeopathic manufacturing site

1,225

Wholesaler’s authorisations

Large full line

3,395

Medium full line / short line

1,930

Small short line

735

Minor site / Procure & supply

490

Active substances register

Active substances distributor

305

Active substances importer

610

Active substances manufacturer

1,225

Organ establishment authorisations

Major establishment (more than 250 employees)

20,415

Large establishment (150-250 employees)

13,610

Medium establishment (50-149 employees)

9,075

Small establishment (less than 50 employees)

4,535

Minor establishment (less than 5 employees)

1,225

Fees in relation to protection of animals used for scientific purposes

Project fees

Project application without ethical approval

2,270

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

330

Band 2: Establishment with 4-10 individual authorisation holders

655

Band 3: Establishment with 11-20 individual authorisation holders

1,005

Band 4: Establishment with 21-40 individual authorisation holders

1,900

Band 5: Establishment with 41-70 individual authorisation holders

2,890

Band 6: Establishment with 71-100 individual authorisation holders

3,860

Band 7: Establishment with 101-150 individual authorisation holders

6,530

Band 8: Establishment with 151 - 200 individual authorisation holders

9,500

Band 9: Establishment with >201 individual authorisation holders

12,470

Individual authorisation fees

Application fee

315

Annual fee

315

Once-off authorisation - procedural training for a period of two months or less (reduced fee)

110

Fees for follow-up inspections

Per day (per member of the inspection team)

1,825

Part of day (per hour, per member of the inspection team)

260

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)

1,825

Part of day (per hour, per member of the inspection team)

260

Inspection cancellation/rescheduling fee

500

Enforcement fees

Manufacturers

Major site (more than 250 employees)

2,940

Large site (150-250 employees)

2,205

Medium site (50-149 employees)

735

Small site (less than 50 employees)

245

Wholesalers

Large full line

735

Medium full line / short line

245

Marketing authorisation / parallel import licence holders

> 50 marketing authorisations / parallel import licences

3,860

31-50 marketing authorisations / parallel import licences

1,225

16-30 marketing authorisations / parallel import licences

735

6-15 marketing authorisations / parallel import licences

245

(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 1993

6

(‘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

2

(‘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 €3 million

1,000

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

European Union Reference Laboratories

European Union Reference Laboratory (EURL) Application Verification

2,700

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

Letter confirming that a device or a list of devices are registered with the HPRA

120

Registration of Devices

Online Registration - Administration fee

140

Clinical Investigations and IVDR performance studies

Class III and Class IIb medical devices, including relevant MDR Annex XVI clinical investigations

4,300

Class IIa and Class I devices, including relevant MDR Annex XVI clinical investigations

1,900

Notifications and substantial modifications to notifications in accordance with MDR article 74(1), Article 82, IVDR Article 58(2) and IVDR Article 70(1)

200

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)

2,500

Notification of Performance study involving Companion Diagnostic IVD using left over samples (IVDR Article 58(2))

265

Substantial modifications and technical amendment to a previously approved clinical investigation/performance study

1,240

Resubmission of a clinical investigation/performance study following a withdrawal or objection or if the application has lapsed

1,900

Resubmission of a clinical investigation/performance study - Academic Sponsor

510

Determination of classification within the medical devices regulations

Determination not requiring a complex technical review (one device per request)

280

Complex classification requests

1,020

Arbitration Fee

5,000

Appeal of a classification opinion

600

Designation Fee for a Notified Body

Initial designation of a notified body and to the re-assessment of the notified body under the new Device Regulations 745 and 746 of 2017

10,200

Extensions to the scope (per extension)

5,100

Medicinal Product / Medical Device - Drug Consultation Fees

New active substance

48,030

Established active in new therapeutic area

12,005

Established active and therapeutic area

6,965

Variations - Minor

1,010

Variations - Major

4,535

Assessments under Article 59 of the MDR and Article 54 of the IVDR

Assessment fee

4,000

Miscellaneous - Medical Devices

Search fee of medical devices data base

65

Daily charge-out rate for Technical Services

1,675

Hourly charge-out rate for Technical Services

265

Hourly charge-out rate for Administrative Services

80

Fees in relation to clinical trials under European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 (

S.I. No. 190 of 2004

)

Request for authorisation under Regulation 14 - Phase I, II, III or IV clinical trials

Investigational medicinal product containing an established active substance

605

Investigational medicinal product containing a new active substance

1,620

Amendment to authorisation under Regulation 21

Notice of amendment

410

Notice of amendment to include a new investigational medicinal product dossier

880

Fees in relation to clinical trials under European Union (Clinical Trials on Medicinal Products for Human Use) (Principal) Regulations 2022 (

S.I. No. 99 of 2022

)

Applications with an investigational medicinal product dossier

Mono National

3,420

Ireland - Reporting Member State

8,700

Ireland - Concerned Member State, initial, transitional or additional applications

3,200

Supplement - Where Ireland subsequently becomes the Reporting Member State

5,280

Reporting Member State - 2

nd

& subsequent waves

1,000

Non Commercial/Academic Trials

300

Applications with no investigational medicinal product dossier or with a simplified investigational medicinal product dossier

Mono National

2,405

Ireland - Reporting Member State

7,500

Ireland - Concerned Member State, initial, transitional or additional applications

2,135

Supplement - Where Ireland subsequently becomes the Reporting Member State

5,095

Reporting Member State - 2

nd

& subsequent waves

1,000

Non Commercial/Academic Trials

300

Substantial Modifications (Parts I & II or Part I only) - with the addition of a new investigational medicinal product dossier

Mono National

1,380

Ireland - Reporting Member State

1,600

Ireland - Concerned Member State

1,325

Non Commercial/Academic Trials

100

Substantial Modifications - other

Mono National

910

Ireland - Reporting Member State

1,210

Ireland- Concerned Member State

830

Non Commercial/Academic Trials

100

Substantial Modifications - Part II only

Substantial Modification

400

Non Commercial/Academic Trials

50

Fees for Appeals

Appeal of clinical trial decision - Commercial

1,200

Appeal of clinical trial decision - Non-commercial

100

Fees for Safety Reports

Review of Annual Safety reports/ Drug safety update reports

220

Review of drug safety update reports where Ireland is the lead member state under a work sharing procedure or Safety assessment member state (saMS)

1,125

Fees for Inspections

per day (per member of the inspection team)

1,825

per hour (per member of the inspection team)

260

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

280

Amendment to registered details

155

GIVEN under my Official Seal,

15 December, 2022.

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 2021 (

S.I. No. 744 of 2021

).

These Regulations may be cited as the Health Products Regulatory Authority (Fees) Regulations 2022.

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 130, 24.4.2020, p. 18.

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

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

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

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

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

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

20

th December,

2022.

I, STEPHEN DONNELLY, Minister for Health, in exercise of the powers conferred on me 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