S.I. No. 531/2018 - Health Products Regulatory Authority (Fees) (No. 2) Regulations 2018

1. These Regulations may be cited as the Health Products Regulatory Authority (Fees) (No. 2) Regulations 2018.

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 (

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;

“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 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 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

2

;

“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 2018 (

S.I. No. 208 of 2018

) are revoked.

SCHEDULE

COLUMN 1

COLUMN 2

Fees for national applications for marketing authorisations

€

Complex dossier

National application

20,000

Each additional form (same time)

7,000

Each additional strength (same time)

1,000

Additional drug master file submitted

4,000

Reduced dossier — complex

National application

15,000

Each additional form (same time)

7,000

Each additional strength (same time)

1,000

Additional drug master file submitted

4,000

Reduced dossier — standard

National application

10,000

Each additional form (same time)

7,000

Each additional strength (same time)

1,000

Additional drug master file submitted

4,000

Subsequent extension applications

First additional form

10,000

Each additional form (same time)

7,000

First additional strength (existing form)

3,000

Each additional strength (same time)

1,000

Additional drug master file submitted

4,000

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

Complex dossier

Mutual recognition incoming

14,000

Each additional form (same time)

5,000

Each additional strength (same time)

1,000

Outgoing mutual recognition supplement

15,000

Decentralised incoming

20,000

Decentralised outgoing

50,000

Each additional form (same time)

7,000

Each additional strength (same time)

1,000

Additional supplement where there are 15 or more concerned Member States

1,500

Reduced dossier — complex

Mutual recognition incoming

10,000

Each additional form (same time)

5,000

Each additional strength (same time)

1,000

Outgoing mutual recognition supplement

15,000

Decentralised incoming

15,000

Decentralised outgoing

40,000

Each additional form (same time)

7,000

Each additional strength (same time)

1,000

Additional supplement where there are 15 or more concerned Member States

1,500

Reduced dossier — standard

Mutual recognition incoming

7,000

Each additional form (same time)

4,000

Each additional strength (same time)

1,000

Outgoing mutual recognition supplement

10,000

Decentralised incoming

10,000

Decentralised outgoing

26,000

Each additional form (same time)

7,000

Each additional strength (same time)

1,000

Additional supplement where there are 15 or more concerned Member States

1,500

Subsequent extension applications

Mutual recognition incoming (first additional form)

7,000

Mutual recognition incoming (first additional strength)

2,000

Mutual recognition incoming (subsequent additional strength)

1,000

Outgoing mutual recognition/decentralised supplement (additional form)

3,000

Outgoing mutual recognition/decentralised supplement (additional strength)

1,000

Decentralised incoming (first additional form)

10,000

Decentralised outgoing (first additional form)

26,000

Each additional form (same time)

7,000

First additional strength (existing form)

3,000

Each additional strength (same time)

1,000

Additional supplement where there are 15 or more concerned Member States

1,500

Switching applications

Switching applications

5,100

Fees for parallel import licences

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

1,831

Each additional strength per country

545

Each additional form per country

545

Parallel imports — dual pack registration

915

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

545

Parallel imports where the originator is not on the Irish market

5,508

Change of ownership per product range

578

Fees for variations to national marketing authorisations

Type IB variation

516

Type IB variation — reduced rate

258

Type II complex variation

2,865

Type II complex variation — reduced rate

558

Type II standard variation

558

Type II standard variation — reduced rate

278

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

275

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

138

Multiple variations capped fee (per product range)

5,288

Multiple variations capped fee (per product)

3,415

Worksharing capped fee

5,728

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

Type IB variation outgoing mutual recognition / decentralised supplement

380

Type IB variation — mutual recognition incoming

372

Type IB variation — mutual recognition incoming — reduced rate

192

Type II complex variation — outgoing mutual recognition / decentralised Supplement

578

Type II complex variation — mutual recognition incoming

1,980

Type II complex variation — mutual recognition incoming — reduced rate

372

Type II standard variation — mutual recognition incoming

372

Type II standard variation — mutual recognition incoming — reduced rate

192

Type II standard variation — outgoing mutual recognition / decentralised Supplement

372

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

275

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

138

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

Change of ownership — related company — 1st marketing authorisation within a range

991

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

354

Change of ownership — non-related company — 1st marketing authorisation within a range

1,450

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

354

Other fees relating to the granting of marketing authorisations

Service item

674

Notification to become a listed organisation

Notification Fee

10

Fees for applications for wholesaler’s authorisations

Application fee

611

Variation to authorisation — minor site technical

441

Variation to authorisation — administrative

241

Variation to authorisation — technical

664

Fees for applications for manufacturer’s authorisations

Application fee

2,041

Variation to authorisation — administrative

302

Variation to authorisation — technical

846

Variation to authorisation — investigational medicinal product — fast track

1,200

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

Registration fee — importers and distributors of active substances and Brokers

275

Registration fee — manufacturers of active substances

486

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

846

Notification of an administrative change to the active substances register

150

Notification of any change to the brokers register

150

Fees for applications for organ establishment authorisations

Application charge

2,041

Variation to authorisation — administrative

302

Variation to authorisation — technical

846

Appeal to amend/revoke an authorisation

551

Fees for transferring of authorisation/registration to another company

Manufacturer's authorisation and organ establishment authorisation

Related companies

1,219

Unrelated companies

2,041

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

Related companies

402

Unrelated companies

611

Fees for applications in relation to cosmetic products

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

162

Certificates of free sale — fast track (4 certs per request)

305

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

747

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

1,119

New application — national rules scheme standard fee — single stock

1,119

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

1,652

Mutual recognition incoming application standard fee — single stock

498

Mutual recognition incoming application standard fee — 2 or more stocks

747

Outgoing mutual recognition / decentralised supplement

621

National variation — registration and national rules scheme

373

National variation — reduced rate — registrations and national rules scheme

187

Mutual recognition incoming variation

249

Mutual recognition incoming variation — reduced rate

124

Variation — outgoing mutual recognition / decentralised supplement

187

Bulk variation for multiple changes to the masterfile

2,245

Fees for applications in relation to traditional herbal medicinal products

National applications for certificates of traditional-use registration

National application

5,385

National application where there is a monograph

3,305

Each additional form (same time)

4,486

Each additional strength (same time)

579

Additional drug master file submitted

3,581

Extension applications

First additional form

5,385

Each additional form (same time)

4,485

First additional strength

2,429

Each additional strength (same time)

579

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

Mutual recognition incoming

3,765

Mutual recognition incoming — each additional form (same time)

2,520

Mutual recognition incoming — each additional strength (same time)

579

Outgoing mutual recognition / decentralised supplement

4,897

Decentralised outgoing/incoming

5,385

Each additional form (same time)

4,486

Each additional strength (same time)

579

Traditional herbal medicinal products

—

national variations

Type IB variation — national

413

Type IB variation — reduced rate

210

Type II standard variation

441

Type II standard variation — reduced rate

220

Type II complex variation

2,313

Bulk variation for multiple changes

4,627

Traditional herbal medicinal products — mutual recognition variations

Type IB variation — mutual recognition incoming

297

Type IB variation — mutual recognition incoming — reduced rate

154

Type IB variation — outgoing mutual recognition supplement

303

Type II standard — mutual recognition incoming

297

Type II standard — mutual recognition incoming — reduced rate

154

Type II standard — outgoing mutual recognition supplement

297

Type II complex — mutual recognition incoming

1,581

Type II complex — outgoing mutual recognition supplement

462

Fees for export certificates and certification of documents

Standard

162

Fast track

305

Annual maintenance fees

Marketing authorisations and registrations

First 10 marketing authorisations

716

Additional marketing authorisations

894

Dormant marketing authorisations

463

Parallel import licence

124

Parallel import licence — Dual pack

61

Certificate of registration — homeopathic medicinal products

61

Certificate of traditional-use registration — traditional herbal medicinal products

124

Manufacturer’s authorisations

Major site (more than 250 employees)

18,363

Large site (150-250 employees)

12,241

Medium site (50-149 employees)

8,162

Small site (less than 50 employees)

4,079

Homeopathic manufacturing site

1,102

Wholesaler’s authorisations

Large full line

3,053

Medium full line/ short line

1,736

Small short line

661

Minor site / Procure & supply

441

Active substances register

Active substances distributor

275

Active substances importer

551

Active substances manufacturer

1,102

Organ establishment authorisations

Major establishment (more than 250 employees)

18,363

Large establishment (150-250 employees)

12,241

Medium establishment (50-149 employees)

8,162

Small establishment (less than 50 employees)

4,079

Minor establishment (less than 5 employees)

1,102

Project fees

Project application without ethical approval

2,000

Fast track project application

2,000

Breeder/Supplier/User Authorisation fees

Band 1: Small establishment with no animal facilities or establishment with 1-3 individual authorisation holders

275

Band 2: Establishment with 4-10 individual authorisation holders

550

Band 3: Establishment with 11-20 individual authorisation holders

850

Band 4: Establishment with 21-50 individual authorisation holders

1,600

Band 5: Establishment with 51-100 individual authorisation holders

3,250

Band 6: Establishment with 101-150 individual authorisation holders

5,500

Band 7: Establishment with 151 — 200 individual authorisation holders

8,000

Band 8: Establishment with >201 individual authorisation holders

10,500

Individual authorisation fees

Application fee

260

Annual fee

260

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)

1,640

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

235

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)

1,640

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

235

Enforcement fees

Manufacturers

Major site (more than 250 employees)

2,644

Large site (150-250 employees)

1,983

Medium site (50-149 employees)

661

Small site (less than 50 employees)

220

Wholesalers

Large full line

661

Medium full line / short line

220

Marketing authorisation / parallel import licence holders

> 50 marketing authorisations / parallel import licences

3,470

31-50 marketing authorisations / parallel import licences

1,102

16-30 marketing authorisations / parallel import licences

661

6-15 marketing authorisations / parallel import licences

220

(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

30,000

Manufacturer — 100-150 employees

20,000

Manufacturer — 50-99 employees

15,000

Manufacturer — 16-49 employees

5,000

Manufacturer — 5-15 employees

1,250

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 €5,000)

1,250

(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 €60,000.)

Distributors — annual fees

Large distributor (turnover greater than €15 million)

4,500

Medium distributor (turnover €3-€15 million)

2,500

Small distributor (turnover under €3 million)

1,250

Distributor turnover less than €500,000

250

Notified Body — annual fees

5,000

Summary evaluation review fees

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

1,000

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

3,000

Certificates of free sale for medical devices

Certificate of free sale (4 certificates per request)

250

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

23

Given under my official seal,

11 December 2018.

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) Regulations 2018 (

S.I. No. 208 of 2018

).

These Regulations may be cited as the Health Products Regulatory Authority (Fees) (No. 2) Regulations 2018.

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

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

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

14

th December

, 2018.

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