S.I. No. 700/2019 - Health Products Regulatory Authority (Fees) Regulations 2019


Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 10th January, 2020.

I, SIMON HARRIS, 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:

1. These Regulations may be cited as the Health Products Regulatory Authority (Fees) Regulations 2019.

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 );

“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 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 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;

“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 (No. 540 of 2007);

“Control of Wholesale Distribution Regulations” means the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (S.I. 538 of 2007);

“decentralised procedure” means the decentralised procedure for human medicinal products provided for in Directive 2001/83/EC;

“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 medical devices, means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a medical device available on the market;

“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. 2) Regulations 2015 ( S.I. No. 449 of 2015 )) of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 ( S.I. No. 540 of 2003 );

“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;

“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;

“manufacturer”, in the context of medical devices, means—

(a) a person who is responsible for the design, manufacture, packaging and labelling of a medical device before it is placed on the market under his or her own name, regardless of whether these operations are carried out by that person himself or herself or on his or her behalf by a third party, or

(b) 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 medical device with a view to their being placed on the market under his or her own name, but not including a person who assembles or adapts medical devices already on the market to their intended purpose for an individual patient;

“manufacturer’s authorisation” has the meaning assigned to it by Regulation 3(1) of the Medicinal Products (Control of Manufacture) Regulations 2007;

“manufacturing site”, in the context of medical devices, means a site where an entity—

(a) manufactures a medical device,

(b) manufactures critical components of a medical device to a set of specifications,

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

(d) carries out labelling activities in relation to a medical device;

“marketing authorisation” means a marketing authorisation granted pursuant to the Control of Placing on the Market Regulations;

“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of—

(a) diagnosis, prevention, monitoring, treatment or alleviation of disease,

(b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

(c) investigation, replacement or modification of the anatomy or of a physiological process, or

(d) control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means, and includes—

(i) an in vitro diagnostic medical device in accordance with the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001, and

(ii) an active implantable medical device in accordance with the European Communities (Active Implantable Medical Devices) Regulations 1994;

“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;

“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 (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;

“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 20082 ;

“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) (No .2) Regulations 2018 (S.I. No. 531 of 2018) 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 six 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 six 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 six 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 Supplement

590

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 Supplement

380

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 – investigational medicinal product – 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

Related companies

1,245

Unrelated companies

2,080

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

Related companies

410

Unrelated companies

625

Fees for applications in relation to cosmetic products

Certificates of free sale – standard (4 certs per request)

165

Certificates of free sale – fast track (4 certs 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 authorisations

910

Dormant marketing authorisations

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

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 rescheduling fee

1,000

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 medical devices

Manufacturers and authorised representatives – annual fees

Manufacturer - more than 150 employees

30,600

Manufacturer - 100-150 employees

20,400

Manufacturer - 50-99 employees

15,300

Manufacturer - 16-49 employees

5,100

Manufacturer - 5-15 employees

1,275

Manufacturer - less than 5 employees or annual turnover of less than €500,000

250

Authorised representative/legal manufacturer which is not a manufacturer (of medical devices) (maximum of €5,100)

1,275

(Note: Where one organisation has multiple manufacturing sites based in the State, the organisation will be charged per manufacturing site to a maximum fee of €61,200.)

Distributors – annual fees

Large distributor (turnover greater than €15 million)

4,590

Medium distributor (turnover €3-€15 million)

2,550

Small distributor (turnover under €3 million)

1,275

Distributor turnover less than €500,000

250

Notified Body – annual fees

5,100

Summary evaluation review fees

Medical Devices using starting materials for which a TSE certificate of suitability has been submitted

2,500

Medical Devices using starting materials for which a TSE certificate of suitability has not been submitted

5,000

Certificates of free sale for medical devices

Certificate of free sale (4 certificates per request)

255

Duplicate certificates of free sale – each (available at time of request)

25

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GIVEN under my Official Seal,

20 December, 2019.

SIMON HARRIS,

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) (No. 2) Regulations 2018 (S.I. No. 531 of 2018).

These Regulations may be cited as the Health Products Regulatory Authority (Fees) Regulations 2019.

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

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