Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 22nd June, 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:

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

“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 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) Regulations 2017 ( S.I. No. 557 of 2017 ) are revoked.

SCHEDULE

COLUMN 1 COLUMN 2

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

Fees for parallel import licences

Fees for variations to national marketing authorisations

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

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

Other fees relating to the granting of marketing authorisations

Notification to become a listed organisation

Fees for applications for wholesaler’s authorisations

Fees for applications for manufacturer’s authorisations

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

Fees for applications for organ establishment authorisations

Fees for transferring of authorisation/registration to another company

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

Fees for applications in relation to cosmetic products

Fees for applications in relation to homeopathic medicinal products

Fees for applications in relation to traditional herbal medicinal products

Fees for export certificates and certification of documents

Annual maintenance fees

Project fees

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

Enforcement fees

(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

(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

Notified Body — annual fees 3,000

Summary evaluation review fees

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,

19 June 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 2017 ( S.I. No. 557 of 2017 ).

These Regulations may be cited as the Health Products Regulatory Authority (Fees) Regulations 2018.

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

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