Ireland: Life Sciences Law Review 2018

Last Updated: 29 May 2018
Article by Colin Kavanagh and Ciara Farrell
Most Read Contributor in Ireland, October 2018


i Regulatory framework

The regulatory framework for medicinal products in Ireland is based on Directive 2001/ 83/EC on the Community code relating to medicinal products for human use (as amended) (the Community Code). This was implemented in Ireland by the Irish Medicines Board Act 1995 (as amended) (IMB Act) and domestic regulations, most notably the Medicinal Products (Control of Placing on the Market) Regulations 2007 (SI 540/2007) (as amended) (Marketing Regulations).

The regulatory framework for medical devices in Ireland is based on the following directives that have been transposed into Irish law: Directive 93/42/EEC concerning medical devices, Directive 90/385/EEC on active implantable medical devices (as amended) and Directive 98/79/EC on in vitro diagnostic medical devices (IVD Directive) (as amended). National legislation transposing those Directives (as amended) include the European Communities (Medical Devices) Regulations 1994 (SI 252/1994) (as amended in 2001, 2002 and 2009), the European Communities (Active Implantable Medical Devices) Regulations 1994 (SI 253/1994) (as amended in 2009), the European Communities (In Vitro Diagnostic Medical Devices) Regulations 2001 (SI 304/2001) (as amended in 2012), the European Communities (Medical Devices) (Reclassification of Breast Implants) Regulations (SI 358/2003) 2003, the European Communities (Medical Devices) (Tissues of Animal Origin) Regulations 2003 (SI 554/2003) and the European Communities (Medical Devices) (Reclassification of Hip, Knee and Shoulder Joint Replacements) (Amendment) Regulations 2007 (SI 92/2007) (collectively, the Medical Devices Legislation). The existing Medical Devices Legislation is due to be overhauled when the new EU Regulation 2017/745 on medical devices and Regulation 2017/746 on in vitro diagnostic medical devices (which formally entered into force at the end of May 2017) come into effect – 2020 for medical devices and 2022 for in vitro diagnostic medical devices. These two Regulations represent a significant development and updating of the existing regulatory system for medical devices in Europe and will replace the original EU Directives, which have been in place for over 25 years.

ii Regulatory authorities

The Health Products Regulatory Authority (HPRA; formerly the IMB)2 is the competent authority responsible for regulating medicinal products, medical devices, cosmetics and other health products in Ireland. The National Standards Authority of Ireland (NSAI) is the notified body in Ireland designated by the HPRA to carry out conformity assessment procedures to ensure compliance with the Medical Devices Legislation. The HPRA's main areas of responsibility are:

  1. ensuring the quality, safety and efficacy of medicinal products (including veterinary medicinal products) available in Ireland, participating in systems designed to do so throughout the European Union, and monitoring the quality of medicinal products and their manufacturing and distribution processes;
  2. acting as the competent authority for the implementation of EU and national legislation relating to blood, blood components, tissues, cells and medical clinical research, and cosmetics;
  3. regulating medical devices on the Irish market;
  4. regulating the protection of animals used for scientific purposes; and
  5. regulatory functions in respect of organs intended for transplantation.


i Classification

The decision as to whether a product will be deemed a medicinal product, a medical device or other regulated product will largely depend on the particular intended use of the product, as assigned by the manufacturer, and on the demonstrated mode of action. In arriving at any decision with regard to classification, the applicant must provide the HPRA with sufficient information about the product and its intended usage, including all promotional material. This includes not only labels, leaflets and all advertising materials but also any websites linked to that literature. In the event that the HPRA determines that the product could potentially be a medicinal or other product, the product may be referred to the HPRA Classification Committee, which meets once a month and is responsible for assessing products for which classification is not obvious, including those that are borderline medical devices or medicinal products. Alternatively, classification requests for borderline products may be sent directly to the Classification Committee as opposed to being referred by the HPRA.

Decisions made by the Classification Committee can be appealed to the HPRA Management Committee, which may request the advice of the Advisory Committee on Human Medicines (ACHM) set up under the IMB Act. The decision of the Management Committee is final.

ii Non-clinical studies

Non-clinical studies (e.g., non-interventional studies) are not regulated by the applicable laws and guidance for clinical trials in Ireland. They do not require the positive opinion of an ethics committee. There is, however, general legislation that applies, such as data protection legislation, the common law on consent for medical treatment and research, animal welfare protection laws and good laboratory practice.

Directive 2010/63/EU was transposed into Irish law in December 2012 by the European Union (Protection of Animals used for Scientific Purposes) Regulations 2012 (SI 543/2012) (as amended). This legislation aims to improve the welfare of animals used for scientific purposes and to promote the principles of the three Rs – replacement, reduction and refinement:

  1. Replacement refers to the use of alternative methods that substitute the use of animals for scientific purposes. Where replacement is not possible, animal use must only be permitted where justified and where the expected benefits outweigh the potential adverse effects.
  2. Reduction measures must be applied so as to minimise the number of animals used in each research project.
  3. Refinement measures must also be applied to enable procedures to be carried out in the most humane manner possible and to minimise pain, suffering, distress and lasting harm.

European Communities (Good Laboratory Practice) Regulations 1991 (SI 4/1991) (as amended) give effect to Commission Directive 2004/10/EC, which requires certain testing on chemicals to be carried out in accordance with the Principles of Good Laboratory Practice. The Irish National Accreditation Board has statutory responsibility for enforcement of these regulations.

iii Clinical trials

Medicinal products

Clinical trials in Ireland are regulated by the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 to 2009 (Clinical Trial Regulations), which implement Directive 2001/20/EC on the conduct of clinical trials (Clinical Trials Directive) and Directive 2005/28/EC on good clinical practice for medicinal products for human use (GCP Directive).

The Clinical Trial Regulations apply to clinical trials conducted with human subjects and involving investigational medicinal products (IMP). On 16 April 2014, the new Clinical Trials Regulation (Regulation No. 536/2014) was adopted. It will repeal the Clinical Trials Directive and its aim is to simplify and harmonise the authorisation of clinical trials across the European Union. The new Regulation is expected to enter into force six months after the full functionality of a new EU Database and single online EU Portal created under the new Regulation. Clinical trials will, however, continue to be conducted in accordance with the Clinical Trials Directive until the new regulation becomes applicable.


A clinical trial authorisation (CTA), issued by the HPRA, must be obtained by a sponsor or person authorised to act on his or her behalf prior to commencing a clinical trial. An investigational medicinal product dossier should be submitted to the HPRA providing clinical and non-clinical supporting data for the investigational medicinal product, with evidence of the favourable ethics committee opinion and the sponsor's EudraCT number (see 'Trial preconditions', below).

Informed consent

The sponsor must obtain each trial subject's informed consent and inform each trial subject of the trial procedure and his or her right to withdraw at any time. Other conditions apply with respect to the requirements of the applicable data protection legislation and the Clinical Trials Regulations. Documentation relating to these matters must be submitted to the ethics committee for opinion before the application for a CTA is made to the HPRA (see below).

Trial preconditions

The following items must be satisfied before a clinical trial can commence:

  1. the sponsor, or the person authorised to act on his or her behalf in relation to the trial, is established in the European Union;
  2. the sponsor has registered with the European Economic Area (EEA) system for monitoring drug safety, EudraVigilance;
  3. a favourable ethics committee opinion in relation to the trial protocol has been obtained;
  4. the HPRA has granted a CTA; and
  5. insurance and indemnity cover for the conduct of the trial has been obtained.

To facilitate the effective initiation of clinical trials and the removal of administrative barriers, a single HSE clinical trial indemnity form (CTIF) has been agreed between the State Claims Agency and the Irish Pharmaceutical Healthcare Association (IPHA) for the conduct of industry-led clinical trials in Ireland. The CTIF is applicable to the conduct of any industry-sponsored clinical trial in any state hospital in Ireland. Use of the HSE CTIF, which refers to the IPHA clinical trial compensation guidelines, provides the assurance that the company sponsoring a clinical trial will, without legal commitment, adhere to certain guidelines in the event of injury caused to a patient that is attributable to participation in the trial in question.

Medical devices

Devices carrying the CE mark may be freely marketed anywhere in the European Union.3 Clinical assessments are usually required before non-CE marked medical devices may enter the Irish market. For any clinical investigation to commence in Ireland, approval from the HPRA is required, with a positive opinion of an ethics committee. Note that certain clinical investigations, such as those using CE-marked devices within their intended purpose, may not require a review by the HPRA. This must be assessed on a case-by-case basis.

Typically, applications are submitted by a commercial sponsor, such as a medical device manufacturer. By this application, the manufacturer is proposing to conduct an investigation to gather the necessary clinical data to demonstrate the basic safety and performance of their device. The requirements governing the conduct of clinical investigations are laid down in Directive 93/42/EEC and in the IVD Directive, as well as various Commission guidance documents (MEDDEVs) and international standards. The HPRA reviews the regulatory, technical and clinical aspects of the application. The HPRA reviews applications to conduct clinical investigations in Ireland in parallel with the appropriate ethics committee review. An initial decision will be issued within 30 days of the application being made, and the final decision will be provided by the HPRA within 60 days of the application.

iv Named-patient and compassionate use procedures

Medicinal products

Named-patient programmes

Regulation 2 of Schedule 1 of the Marketing Regulations regulates named-patient programmes in Ireland. Under the Marketing Regulations, a named-patient programme permits the sale or supply of an unauthorised product in response to a bona fide unsolicited order, formulated in accordance with the specifications of a practitioner for use by his or her individual patients on his or her direct personal responsibility, to fulfil the special needs of those patients.

To make use of the programme, the following conditions must be satisfied:

  1. receipt of an unsolicited order from a registered healthcare professional (HCP);
  2. the product must be supplied to the order or prescription of the requesting HCP;
  3. the product is only provided to the HCP's individual patient; and
  4. the provision of the product is supervised under the direct personal responsibility of the HCP.

There is no formal authorisation for establishing a named-patient programme in Ireland. However, wholesalers and manufacturers that receive or import exempt medicinal products intended for distribution in Ireland under a named-patient programme must notify the HPRA of this fact within two working days of receipt of the consignment. There are a number of exceptions to this notification requirement, all of which depend on the specific supply chain in question. Packaging and labelling requirements will apply, as well as fees and record-keeping obligations in terms of pharmacovigilance and quality defects.

Compassionate use

Medicinal products for use in an authorised clinical trial are exempt from the requirement to be subject to a marketing authorisation (MA). The HPRA does recognise the option of an Expanded Access Programme (EAP) for patients who have been treated with a medicinal product during a clinical trial and wish to continue treatment after the trial is completed. If, however, the EAP fulfils the definition of a clinical trial, it is required to be authorised as such under the applicable Irish legislation. In the event that it does not fulfil the definition of a clinical trial, the medicinal product can only be supplied via a named-patient programme. This essentially means that EAPs for groups of patients at a time are only recognised in Ireland if they are authorised as clinical trials and meet all applicable legislation governing clinical trials.

Medical devices

The CE marking does not have to be present on medical devices intended for clinical investigations, custom-made devices and in vitro diagnostic medical devices for performance evaluation. The CE marking does not have to be present on medical devices intended for exhibitions, demonstrations, trade fairs, etc. However, these devices must bear a visible marking indicating that they are not intended to be marketed or put into use.

To read this article in full, please click here.


1. Colin Kavanagh is a partner and Ciara Farrell is an associate at Arthur Cox.

2. See

3. Where the medical device is to be exported outside the European Economic Area, it will be necessary to apply to the HPRA for a Certificate of Free Sale.

Originally published by Law Business Research Ltd., April 2018.

This article contains a general summary of developments and is not a complete or definitive statement of the law. Specific legal advice should be obtained where appropriate.

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