S.I. No. 607/2014 - Health Products Regulatory Authority (Fees) Regulations 2014.

1. These Regulations may be cited as the Health Products Regulatory Authority (Fees) Regulations 2014.

2. In these Regulations—

“Act” means the

Irish Medicines Board Act 1995

(No. 29 of 1995), as amended by s. 197 of the

Finance Act 1999

(No. 2 of 1999), Regulation 3 of the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 (

S.I. No. 304 of 2001

), Regulation 2 of the European Communities (Medical Devices) (Amendment) Regulations 2001 (

S.I. No. 444 of 2001

), Regulation 3 of the European Communities (Medical Devices) (Amendment) Regulations 2002 (

S.I. No. 576 of 2002

), the

Irish Medicines Board (Miscellaneous Provisions) Act 2006

(No. 3 of 2006), the European Communities (Amendment of the Medicines Board Act 1995) Regulations 2007 (

S.I. No. 542 of 2007

) and

section 36

of the

Health (Pricing and Supply of Medical Goods) Act 2013

;

“active substances register” means the register of importers, manufacturers and distributors of active substances maintained by the Authority in pursuance of Regulation 14D of the Medicinal Products (Control of Manufacture) Regulations 2007 to 2013;

“Authority” means the Health Products Regulatory Authority established by section 3 of the Act;

“broker” means a person carrying out the brokering of medicinal products, as defined in Regulation 4(1) of the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 to 2013;

“brokers register” means the register maintained by the Authority in pursuance of Regulation 14D of the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 to 2013;

“certificate of free sale” means a certificate of free sale issued under section 4(1)(

k

)(ii) of the Act;

“certificate of registration” means a certificate of registration granted pursuant to the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2014;

“certificate of traditional-use registration” means a certificate of traditional-use registration granted pursuant to the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2014 in respect of a traditional herbal medicinal product;

“certification of documents” means the certification, under section 4(1)(

k

)(ii) of the Act, 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;

“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

, as amended by Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003

2

, Commission Directive 2003/63/EC of 25 June 2003

3

, Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004

4

, Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004

5

, Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of 12 December 2006

6

, Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 2007

7

, Directive 2008/29/EC of the European Parliament and of the Council of 11 March 2008

8

, Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009

9

, Commission Directive 2009/120/EC of 14 September 2009

10

, Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010

11

, Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011

12

and Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012

13

;

“export certificate” means a certificate issued under section 4(1)(

k

)(ii) of the Act;

“follow-up inspections” means inspections other than routine inspections;

“homeopathic medicinal product” has the meaning assigned to it by the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2014;

“individual authorisation” means an authorisation granted to an individual under Part 8 of the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 (

S.I. No. 543 of 2012

);

“interchangeable medicinal product” means a medicinal product which falls within a group of interchangeable medicinal products pursuant to the

Health (Pricing and Supply of Medical Goods) Act 2013

(No. 14 of 2013);

“manufacturer’s authorisation” means an authorisation granted pursuant to the Medicinal Products (Control of Manufacture) Regulations 2007 to 2013;

“marketing authorisation” means an authorisation granted pursuant to the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2014;

“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 Medicinal Products (Control of Placing on the Market) Regulations 2007 (

S.I. No. 540 of 2007

);

“organ establishment authorisation” means an authorisation granted pursuant to the European Union (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012 and 2014;

“parallel import licence” has the meaning assigned to it by the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2014;

“project” means a programme of work having a defined scientific objective and involving one or more procedures pursuant to the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 to 2014;

“project authorisation” means an authorisation granted under Part 5 of the European Union (Protection of Animals used for Scientific Purposes) Regulations 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 Board 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;

“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 the Medicinal Products (Control of Placing on the Market) Regulations 2007 to 2014;

“type IA variation”, “type IB variation” and “type II standard variation” shall be classified by the Board in accordance with Commission Regulation (EC) No. 1234/2008 of 24 November 2008

14

, as amended by Commission Regulation (EU) No. 712/2012 of 3 August 2012

15

;

“wholesaler’s authorisation” means an authorisation granted pursuant to the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 to 2013.

3. Subject to Regulation 4, there shall be paid to the Board in respect of each and every matter set out in column 1 of the Schedule the fee as set out in column 2 of the Schedule.

4. The Board 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 Irish Medicines Board (Fees) Regulations 2013 (

S.I. No. 501 of 2013

) are revoked.

SCHEDULE

COLUMN 1

COLUMN 2

Fees for national applications for marketing authorisations

€

Complex dossier

National application

15,211

Each additional form (same time)

5,090

Each additional strength (same time)

656

Additional drug master file submitted

3,251

Reduced dossier — complex

National application

11,329

Each additional form (same time)

5,090

Each additional strength (same time)

656

Additional drug master file submitted

3,251

Reduced dossier — standard

National application

7,658

Each additional form (same time)

5,090

Each additional strength (same time)

656

Additional drug master file submitted

3,251

Subsequent extension applications

First additional form

7,658

Each additional form (same time)

5,090

First additional strength (existing form)

2,756

Each additional strength (same time)

656

Additional drug master file submitted

3,251

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

Complex dossier

Mutual recognition incoming

10,647

Each additional form (same time)

3,660

Each additional strength (same time)

656

Outgoing mutual recognition supplement

10,962

Decentralised incoming

15,211

Decentralised outgoing

40,000

Each additional form (same time)

5,090

Each additional strength (same time)

656

Additional supplement where there are 15 or more concerned Member States

1,000

Reduced dossier — complex

Mutual recognition incoming

8,077

Each additional form (same time)

3,251

Each additional strength (same time)

656

Outgoing mutual recognition supplement

10,962

Decentralised incoming

11,329

Decentralised outgoing

30,000

Each additional form (same time)

5,090

Each additional strength (same time)

656

Additional supplement where there are 15 or more concerned Member States

1,000

Reduced dossier — standard

Mutual recognition incoming

5,350

Each additional form (same time)

2,859

Each additional strength (same time)

656

Outgoing mutual recognition supplement

7,126

Decentralised incoming

7,658

Decentralised outgoing

20,000

Each additional form (same time)

5,090

Each additional strength (same time)

656

Additional supplement where there are 15 or more concerned Member States

1,000

Subsequent extension applications

Mutual recognition incoming (first additional form)

5,350

Mutual recognition incoming (first additional strength)

1,929

Mutual recognition incoming (subsequent additional strength)

656

Outgoing mutual recognition/decentralised supplement (additional form)

2,859

Outgoing mutual recognition/decentralised supplement (additional strength)

656

Decentralised incoming (first additional form)

7,658

Decentralised outgoing (first additional form)

20,000

Each additional form (same time)

5,090

First additional strength (existing form)

2,756

Each additional strength (same time)

656

Additional supplement where there are 15 or more concerned Member States

1,000

Switching applications

Switching applications

5,000

Fees for parallel import licences

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

1,662

Each additional strength per country

495

Each additional form per country

495

Parallel imports of dual pack registrations

831

Registration of parallel imports — each additional strength or form

495

Parallel imports where the originator is not on the Irish market

5,000

Change of ownership per product range

525

Fees for variations to national marketing authorisations

Type IA variation

100

Type IB variation

468

Type IB variation — reduced rate

234

Type II complex variation

2,601

Type II standard variation

506

Type II standard variation — reduced rate

253

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

250

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

125

Multiple variations capped fee (per product range)

5,200

Multiple variations capped fee (per product)

3,400

Worksharing capped fee

5,200

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

Type IA variation — mutual recognition incoming

100

Type IB variation outgoing mutual recognition / decentralised supplement

345

Type IB variation — mutual recognition incoming

338

Type IB variation — mutual recognition incoming — reduced rate

174

Type II complex variation — outgoing mutual recognition / decentralised supplement

525

Type II complex variation — mutual recognition incoming

1,797

Type II standard variation — mutual recognition incoming

338

Type II standard variation — mutual recognition incoming — reduced rate

174

Type II standard variation — outgoing mutual recognition / decentralised supplement

338

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

250

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

125

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

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

900

Change of ownership — related company — additional marketing authorisations within a range

321

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

1,316

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

321

Other fees relating to the granting of marketing authorisations

Service item

612

Interchangeable medicinal products

Application Fee — addition of product to a group of interchangeable products or addition of group of products to the list of interchangeable products

500

Fees for applications for wholesaler’s authorisations

Application fee

555

Variation to authorisation — minor site technical

400

Variation to authorisations — administrative

219

Variation to authorisation — technical

603

Fees for applications for manufacturer’s authorisations

Application fee

1,853

Variation to authorisation — administrative

274

Variation to authorisation — technical

768

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

Registration fee

250

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

768

Notification of an administrative change to the active substances register

136

Notification of any change to the brokers register

136

Fees for applications for organ establishment authorisations

Application charge

1,853

Variation to authorisation — administrative

274

Variation to authorisation — technical

768

Appeal to amend/revoke an authorisation

500

Fees for transferring of authorisation/registration to another company

Manufacturer’s authorisation and organ establishment authorisation

Related companies

1,107

Unrelated companies

1,853

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

Related companies

365

Unrelated companies

555

Fees for applications in relation to medical devices and cosmetic products

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

147

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

277

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

23

Fees for applications in relation to homeopathic medicinal products

New national / decentralised registration standard charge — single stock

678

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

1,016

New application — national rules scheme standard fee — single stock

1,016

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

1,500

Mutual recognition incoming application standard fee — single stock

452

Mutual recognition incoming application standard fee — 2 or more stocks

678

Outgoing mutual recognition / decentralised supplement

564

National variation — registration and national rules scheme

339

National variation — reduced rate — registrations and national rules scheme

170

Mutual recognition incoming variation

226

Mutual recognition incoming variation — reduced rate

113

Variation — outgoing mutual recognition / decentralised supplement

170

Bulk variation for multiple changes to the masterfile

2,038

Fees for applications in relation to traditional herbal medicinal products

National applications for certificates of traditional-use registration

National application

4,888

National application where there is a monograph

3,000

Each additional form (same time)

4,072

Each additional strength (same time)

525

Additional drug master file submitted

3,251

Extension applications

First additional form

4,888

Each additional form (same time)

4,072

First additional strength

2,205

Each additional strength (same time)

525

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

Mutual recognition incoming

3,418

Mutual recognition incoming — each additional form (same time)

2,287

Mutual recognition incoming — each additional strength (same time)

525

Outgoing mutual recognition / decentralised supplement

4,445

Decentralised outgoing/incoming

4,888

Each additional form (same time)

4,072

Each additional strength (same time)

525

Traditional herbal medicinal products

—

national variations

Type IB variation — national

375

Type IB variation — reduced rate

190

Type II standard variation

400

Type II standard variation — reduced rate

200

Type II complex variation

2,100

Bulk variation for multiple changes

4,200

Traditional herbal medicinal products — mutual recognition variations

Type IB variation — mutual recognition incoming

270

Type IB variation — mutual recognition incoming — reduced rate

140

Type IB variation — outgoing mutual recognition supplement

275

Type II standard — mutual recognition incoming

270

Type II standard — mutual recognition incoming — reduced rate

140

Type II standard — outgoing mutual recognition supplement

270

Type II complex — mutual recognition incoming

1,435

Type II complex — outgoing mutual recognition supplement

420

Fees for export certificates and certification of documents

Standard

147

Fast track

277

Annual maintenance fees

Marketing authorisations and registrations

First 10 marketing authorisations

650

Additional marketing authorisations

812

Dormant marketing authorisations

420

Parallel import registration

113

Dual pack registration

55

Homeopathic medicinal products

55

Traditional herbal medicinal products

113

Manufacturer’s authorisations

Major site (more than 250 employees)

16,669

Large site (150-250 employees)

11,112

Medium site (50-149 employees)

7,409

Small site (less than 50 employees)

3,703

Wholesaler’s authorisations

Large full line

2,771

Medium full line/ short line

1,576

Small short line

600

Minor site

400

Procure and supply only

350

Active substances register

Active substances distributor

250

Active substances importer

500

Active substances manufacturer

1,000

Organ establishment authorisations

Major establishment (more than 250 employees)

16,669

Large establishment (150-250 employees)

11,112

Medium establishment (50-149 employees)

7,409

Small establishment (less than 50 employees)

3,703

Project fees

Project application without ethical approval

2,000

Fast track project application

2,000

Establishment fees

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

250

Band 2: Establishment with 4-10 individual authorisation holders

500

Band 3: Establishment with 11-20 individual authorisation holders

750

Band 4: Establishment with 21-50 individual authorisation holders

1,500

Band 5: Establishment with 51-100 individual authorisation holders

3,000

Band 6: Establishment with 101-150 individual authorisation holders

5,000

Band 7: Establishment with 151-200 individual authorisation holders

7,500

Band 8: Establishment with >201 individual authorisation holders

10,000

Individual authorisation fees

Application fee

150

Annual fee

150

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

50

Fees for follow-up inspections

Per day (per member of the inspection team)

1,489

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

213

Inspection fees (other than inspections in relation to the protection of animals used for scientific purposes)

Per day (per member of the inspection team)

1,489

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

213

Enforcement fees

Manufacturers

Major site (more than 250 employees)

2,400

Large site (150-250 employees)

1,800

Medium site (50-149 employees)

600

Small site (less than 50 employees)

200

Wholesalers

Large full line

600

Medium full line / short line

200

Marketing authorisation / parallel import licence holders

> 50 marketing authorisations / parallel import licences

3,150

31-50 marketing authorisations / parallel import licences

1,000

16-30 marketing authorisations / parallel import licences

600

6-15 marketing authorisations / parallel import licences

200

(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 / wholesaler fee.)

GIVEN under my Official Seal,

23 December 2014.

LEO VARADKAR,

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

and

section 29

of the

Health (Pricing and Supply of Medical Goods) Act 2013

.

These Regulations revoke the Irish Medicines Board (Fees) Regulations 2013 (

S.I. No. 501 of 2013

).

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

2 OJ No. L 33, 8.2.2003, p. 30.

3 OJ No. L 159, 27.6.2003, p. 46.

4 OJ No. L 136, 30.4.2004, p. 85.

5 OJ No. L 136, 30.4.2004, p. 34.

6 OJ No. L 378, 27.12.2006, p. 1.

7 OJ No. L 324, 10.12.2007, p. 121.

8 OJ No. L 81, 20.3.2008, p. 51.

9 OJ No. L 168, 30.6.2009, p. 33.

10 OJ No. L 242, 15.9.2009, p. 3.

11 OJ No. L 348, 31.12.2010, p. 74.

12 OJ No. L 174, 1.7.2011, p. 74.

13 OJ No. L 299, 27.10.2012, p. 1.

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

15 OJ No. L 209, 4.8.2012, p. 4.

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

6

th January

, 2015.

I, LEO VARADKAR, 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) and

section 29

of the

Health (Pricing and Supply of Medical Goods) Act 2013

(No. 14 of 2013), hereby make the following Regulations