Health Products Regulatory Authority (Fees) Regulations 2021.
Statutory Instruments
Source: Statutory Instruments

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paragraphs: These Regulations may be cited as the Health Products Regulatory Authority (Fees) Regulations 2021.
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paragraphs: 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 ), or has the meaning assigned to it by—
(a) Article 2(32) of the Medical Devices Regulation, or
(b) Article 2(25) of the IVD Medical Devices Regulation,
as applicable;
“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(a) 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) 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,
(b) a certificate of free sale issued under Article 60 of the Medical Devices Regulation, or
(c) a certificate of free sale issued under Article 55 of the IVD Medical Devices Regulation;
“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;
“device” means –
(a) a medical device,
(b) an accessory for a medical device,
(c) a product listed in Annex XVI to the Medical Devices Regulation, provided that the Medical Devices Regulation applies to such product pursuant to Article 1(2) thereof,
(d) an in vitro diagnostic medical device, or
(e) an accessory for an in vitro diagnostic medical device,
but does not include-
(i) a product or other substance excluded by Article 1(6)(b) to (i) of the Medical Devices Regulation,
(ii) a product or other substance excluded from the scope of the IVD Medical Devices Regulation by Article 1(3) thereof,
(iii) a device referred to in the second subparagraph of Article 1(8), (9) or (10) of the Medical Devices Regulation, or
(iv) an in-house device;
“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 devices, means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;
“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;
“importer”, in the context of devices, means any natural or legal person established within the European Economic Area that places a device from a third country on the market in the European Economic Area;
“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;
“in vitro diagnostic medical device” has the meaning assigned to it by Article 2(2) of the IVD Medical Devices Regulation or by Article 1(2)(b) of Directive 98/79/EC of the European Parliament and of the Council of 27 October 19982 ;
“IVD Medical Devices Regulation” means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 20173 ;
“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. 4) Regulations 2021 ( S.I. No. 81 of 2021 )) of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 ( S.I. No. 540 of 2003 );
“manufacturer”, in the context of devices, means 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 device with a view to their being placed on the market under his or her own name, but not including a person which assembles or adapts devices already on the market to their intended purpose for an individual patient, or has the meaning assigned to it by—
(a) Regulation 2(1) of the European Communities (Medical Devices) Regulations 1994,
(b) Regulation 2(1) of the European Communities (Active Implantable Medical Devices) Regulations 1994,
(c) by Regulation 2(1) of the European Communities (In vitro Diagnostic Medical Devices) Regulations 2001,
(d) Article 2(30) of the Medical Devices Regulation, or
(e) Article 2(23) of the IVD Medical Devices Regulation,
as applicable;
“manufacturer’s authorisation” has the meaning assigned to it by Regulation 3(1) of the Medicinal Products (Control of Manufacture) Regulations 2007;
“manufacturing facility”, in the context of devices, means a place where an entity, which does not place devices on the market under its own name or under its own trademark—
(a) manufactures a device,
(b) manufactures one or more critical components of a device to a set of specifications,
(c) carries out packaging activities in relation to a device, or
(d) carries out labelling activities in relation to a device;
“marketing authorisation” means a marketing authorisation granted pursuant to the Control of Placing on the Market Regulations;
“medical device” has the meaning—
(a) assigned to it by Article 2(1) of the Medical Devices Regulation,
(b) assigned to it by Article 2(2) of the IVD Medical Devices Regulation,
(c) assigned to the term “device” by Regulation 2(1) of the European Communities (Medical Devices) Regulations 1994, or
(d) assigned to the term “device” by Regulation 2(1) of the European Communities (Active Implantable Medical Devices) Regulations 1994,
as applicable;
“Medical Devices Regulation” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 20174 , as amended by Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 20205 ;
“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, or has the meaning assigned to it by—
(a) Article 2(42) of the Medical Devices Regulation, or
(b) Article 2(34) of the IVD Medical Devices Regulation,
as applicable;
“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 ( S.I. 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;
“system or procedure pack producer” means a natural or legal person referred to in—
(a) Article 22(1), (2) or (3) of the Medical Devices Regulation, or
(b) Article 12 of Council Directive 93/42/EEC of 14th June 19936 ,
as applicable;
“switching applications” means applications for a change in the classification of medicinal products under Title VI of Directive 2001/83/EC;
“traditional herbal medicinal product” has the meaning assigned to it by Regulation 3(1) of the Control of Placing on the Market Regulations;
“type IA variation”, “type IB variation” and “type II standard variation” refer to classifications by the Authority in accordance with Commission Regulation (EC) No. 1234/2008 of 24 November 20087 ;
“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.
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paragraphs: 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.
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paragraphs: 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.
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paragraphs: The Health Products Regulatory Authority (Fees) Regulations 2020 ( S.I. No. 654 of 2020 ) are revoked.