S.I. No. 557/2017 - Health Products Regulatory Authority (Fees) Regulations 2017

1. These Regulations may be cited as the Health Products Regulatory Authority (Fees) Regulations 2017.

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

),

section 36

of the

Health (Pricing and Supply of Medical Goods) Act 2013

and the

Health (Miscellaneous Provisions) Act 2017

(No. 1 of 2017);

“active substances register” means the register of importers, manufacturers and distributors of active substances maintained by the Authority in pursuance of Regulation 14D (inserted by Regulation 7 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 to 2009, the European Communities (Active Implantable Medical Devices) Regulations 1994 to 2009, or the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 to 2012;

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

“breeder authorisation” means an authorisation granted to a breeder under Part 6 of the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 to 2016;

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

“brokers register” means the register maintained by the Authority in pursuance of Regulation 14D (inserted by Regulation 6 of the Medicinal Products (Control of Wholesale Distribution) (Amendment) Regulations 2013) of the Medicinal Products (Control of Wholesale Distribution) Regulations 2007;

“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

.

“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 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 Regulation 3(1) of the Medicinal Products (Control of Placing on the Market) Regulations 2007 (

S.I. No. 540 of 2007

);

“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 to 2016;

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

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

manufactures a medical device,

manufactures critical components of a medical device to a set of specifications,

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

carries out labelling activities in relation to a medical device;

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

“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 to 2012, and

(ii) an active implantable medical device in accordance with the European Communities (Active Implantable Medical Devices) Regulations 1994 to 2009;

“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;

“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 to 2009, the European Communities (Active Implantable Medical Devices) Regulations 1994 to 2009, or the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 to 2012;

“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 Regulation 3(1) of the Medicinal Products (Control of Placing on the Market) Regulations 2007;

“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 2016;

“project authorisation” means an authorisation granted pursuant to the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 to 2016;

“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” means an authorisation granted pursuant to the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 to 2016;

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

“type IB variation” and “type II standard variation” shall be classified by the Authority 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

;

“user authorisation” means an authorisation granted to a user pursuant to the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 to 2016;

“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 Authority 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 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 2016 (

S.I. No. 602 of 2016

) are revoked.

SCHEDULE

COLUMN 1

COLUMN 2

Fees for national applications for marketing authorisations

€

Complex dossier

National application

15,515

Each additional form (same time)

5,192

Each additional strength (same time)

669

Additional drug master file submitted

3,316

Reduced dossier — complex

National application

11,556

Each additional form (same time)

5,192

Each additional strength (same time)

669

Additional drug master file submitted

3,316

Reduced dossier — standard

National application

7,811

Each additional form (same time)

5,192

Each additional strength (same time)

669

Additional drug master file submitted

3,316

Subsequent extension applications

First additional form

7,811

Each additional form (same time)

5,192

First additional strength (existing form)

2,811

Each additional strength (same time)

669

Additional drug master file submitted

3,316

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

Complex dossier

Mutual recognition incoming

10,860

Each additional form (same time)

3,733

Each additional strength (same time)

669

Outgoing mutual recognition supplement

11,181

Decentralised incoming

15,515

Decentralised outgoing

40,800

Each additional form (same time)

5,192

Each additional strength (same time)

669

Additional supplement where there are 15 or more concerned Member States

1,020

Reduced dossier — complex

Mutual recognition incoming

8,239

Each additional form (same time)

3,316

Each additional strength (same time)

669

Outgoing mutual recognition supplement

11,181

Decentralised incoming

11,556

Decentralised outgoing

30,600

Each additional form (same time)

5,192

Each additional strength (same time)

669

Additional supplement where there are 15 or more concerned Member States

1,020

Reduced dossier — standard

Mutual recognition incoming

5,457

Each additional form (same time)

2,916

Each additional strength (same time)

669

Outgoing mutual recognition supplement

7,269

Decentralised incoming

7,811

Decentralised outgoing

20,400

Each additional form (same time)

5,192

Each additional strength (same time)

669

Additional supplement where there are 15 or more concerned Member States

1,020

Subsequent extension applications

Mutual recognition incoming (first additional form)

5,457

Mutual recognition incoming (first additional strength)

1,968

Mutual recognition incoming (subsequent additional strength)

669

Outgoing mutual recognition/decentralised supplement (additional form)

2,916

Outgoing mutual recognition/decentralised supplement (additional strength)

669

Decentralised incoming (first additional form)

7,811

Decentralised outgoing (first additional form)

20,400

Each additional form (same time)

5,192

First additional strength (existing form)

2,811

Each additional strength (same time)

669

Additional supplement where there are 15 or more concerned Member States

1,020

Switching applications

Switching applications

5,100

Fees for parallel import licences

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

1,695

Each additional strength per country

505

Each additional form per country

505

Parallel imports — dual pack registration

848

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

505

Parallel imports where the originator is not on the Irish market

5,100

Change of ownership per product range

536

Fees for variations to national marketing authorisations

Type IB variation

477

Type IB variation — reduced rate

239

Type II complex variation

2,653

Type II standard variation

516

Type II standard variation — reduced rate

258

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

255

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

128

Multiple variations capped fee (per product range)

4,896

Multiple variations capped fee (per product)

3,162

Worksharing capped fee

5,304

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

Type IB variation outgoing mutual recognition / decentralised supplement

352

Type IB variation — mutual recognition incoming

345

Type IB variation — mutual recognition incoming — reduced rate

177

Type II complex variation — outgoing mutual recognition / decentralised supplement

536

Type II complex variation — mutual recognition incoming

1,833

Type II standard variation — mutual recognition incoming

345

Type II standard variation — mutual recognition incoming — reduced rate

177

Type II standard variation — outgoing mutual recognition / decentralised supplement

345

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

255

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

128

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

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

918

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

327

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

1,342

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

327

Other fees relating to the granting of marketing authorisations

Service item

624

Notification to become a listed organisation

Notification Fee

10

Fees for applications for wholesaler’s authorisations

Application fee

566

Variation to authorisation — minor site technical

408

Variation to authorisation — administrative

223

Variation to authorisation — technical

615

Fees for applications for manufacturer’s authorisations

Application fee

1,890

Variation to authorisation — administrative

279

Variation to authorisation — technical

783

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

Registration fee — importers and distributors of active substances and Brokers

255

Registration fee — manufacturers of active substances

450

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

783

Notification of an administrative change to the active substances register

139

Notification of any change to the brokers register

139

Fees for applications for organ establishment authorisations

Application charge

1,890

Variation to authorisation — administrative

279

Variation to authorisation — technical

783

Appeal to amend/revoke an authorisation

510

Fees for transferring of authorisation/registration to another company

Manufacturer’s authorisation and organ establishment authorisation

Related companies

1,129

Unrelated companies

1,890

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

Related companies

372

Unrelated companies

566

Fees for applications in relation to cosmetic products

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

150

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

283

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

692

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

1,036

New application — national rules scheme standard fee — single stock

1,036

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

1,530

Mutual recognition incoming application standard fee — single stock

461

Mutual recognition incoming application standard fee — 2 or more stocks

692

Outgoing mutual recognition / decentralised supplement

575

National variation — registration and national rules scheme

346

National variation — reduced rate — registrations and national rules scheme

173

Mutual recognition incoming variation

231

Mutual recognition incoming variation — reduced rate

115

Variation — outgoing mutual recognition / decentralised supplement

173

Bulk variation for multiple changes to the masterfile

2,079

Fees for applications in relation to traditional herbal medicinal products

National applications for certificates of traditional-use registration

National application

4,986

National application where there is a monograph

3,060

Each additional form (same time)

4,153

Each additional strength (same time)

536

Additional drug master file submitted

3,316

Extension applications

First additional form

4,986

Each additional form (same time)

4,153

First additional strength

2,249

Each additional strength (same time)

536

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

Mutual recognition incoming

3,486

Mutual recognition incoming — each additional form (same time)

2,333

Mutual recognition incoming — each additional strength (same time)

536

Outgoing mutual recognition / decentralised supplement

4,534

Decentralised outgoing/incoming

4,986

Each additional form (same time)

4,153

Each additional strength (same time)

536

Traditional herbal medicinal products

—

national variations

Type IB variation — national

383

Type IB variation — reduced rate

194

Type II standard variation

408

Type II standard variation — reduced rate

204

Type II complex variation

2,142

Bulk variation for multiple changes

4,284

Traditional herbal medicinal products — mutual recognition variations

Type IB variation — mutual recognition incoming

275

Type IB variation — mutual recognition incoming — reduced rate

143

Type IB variation — outgoing mutual recognition supplement

281

Type II standard — mutual recognition incoming

275

Type II standard — mutual recognition incoming — reduced rate

143

Type II standard — outgoing mutual recognition supplement

275

Type II complex — mutual recognition incoming

1,464

Type II complex — outgoing mutual recognition supplement

428

Fees for export certificates and certification of documents

Standard

150

Fast track

283

Annual maintenance fees

Marketing authorisations and registrations

First 10 marketing authorisations

663

Additional marketing authorisations

828

Dormant marketing authorisations

428

Parallel import licence

115

Parallel import licence — Dual pack

56

Certificate of registration — homeopathic medicinal products

56

Certificate of traditional-use registration — traditional herbal medicinal products

115

Manufacturer’s authorisations

Major site (more than 250 employees)

17,002

Large site (150-250 employees)

11,334

Medium site (50-149 employees)

7,557

Small site (less than 50 employees)

3,777

Homeopathic manufacturing site

1,020

Wholesaler’s authorisations

Large full line

2,826

Medium full line/ short line

1,608

Small short line

612

Minor site

408

Procure and supply only

357

Active substances register

Active substances distributor

255

Active substances importer

510

Active substances manufacturer

1,020

Organ establishment authorisations

Major establishment (more than 250 employees)

17,002

Large establishment (150-250 employees)

11,334

Medium establishment (50-149 employees)

7,557

Small establishment (less than 50 employees)

3,777

Minor establishment (less than 5 employees)

1,020

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

225

Annual fee

225

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

85

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

Per day (per member of the inspection team)

1,519

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

217

Enforcement fees

Manufacturers

Major site (more than 250 employees)

2,448

Large site (150-250 employees)

1,836

Medium site (50-149 employees)

612

Small site (less than 50 employees)

204

Wholesalers

Large full line

612

Medium full line / short line

204

Marketing authorisation / parallel import licence holders

> 50 marketing authorisations / parallel import licences

3,213

31-50 marketing authorisations / parallel import licences

1,020

16-30 marketing authorisations / parallel import licences

612

6-15 marketing authorisations / parallel import licences

204

(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 — 50-150 employees

25,000

Manufacturer — 15-49 employees

15,000

Manufacturer — 5-15 employees

5,000

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

250

Manufacturer/authorised representative fee per entity (subject to a maximum of €10,000)

1,000

Authorised representative which is not a manufacturer (of medical devices) (maximum of €30,000)

5,000

(Note: Where one organisation has multiple manufacturing sites based in Ireland, 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)

5,500

Medium distributor (turnover €3-€15 million)

3,500

Small distributor (turnover under €3 million)

1,250

Distributor turnover less than €500,000

250

Notified Body — annual fees

3,000

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,

5 December 2017.

SIMON HARRIS,

Minister for Health.

EXPLANATORY NOTE

(This note is not part of the instrument and does not purport to be a legal interpretation.)

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 2016 (

S.I. No. 602 of 2016

).

These Regulations may be cited as the Health Products Regulatory Authority (Fees) Regulations 2017.

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

12

th December

, 2017.

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