This Q&A guide to medicinal product regulation and product liability law in Ireland gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability.
For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit our Product Liability and Product Safety page.
This article first appeared in the Practical Law Multi-Jurisdictional Guide 2014/15 Life Sciences: Practical Law Company – Medicinal Product Regulation & Product Liability 2014 and is reproduced with the kind permission of the publisher Practical Law Company. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.
What are the main legislation and regulatory authorities for pharmaceuticals in your jurisdiction?
Medicinal products.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) (Code for Human Medicines Directive). 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 SI 540/2007 (as amended) (Marketing Regulations).
Pricing and reimbursement of medicinal products. A Framework Agreement between the Irish Pharmaceutical Healthcare Association (IPHA), an organisation representing the international research-based pharmaceutical industry in Ireland, the Department of Health and the Health Services Executive (HSE) came into effect on 1 November 2012 (IPHA Agreement) (see Questions 5 and 6).
The Irish Medicines Board (IMB) (www.imb.ie) is the competent authority responsible for regulating medicinal products and medical devices. The IMB is a statutory body created by the IMB Act. The National Standards Authority of Ireland (NSAI) is the notified body in Ireland approved by the IMB to carry out conformity assessment procedures to ensure compliance with medical devices legislation.
The IMB’s main areas of responsibility are:
- Ensuring the quality, safety and efficacy of medicines (including veterinary medicines) available in Ireland, participating in systems designed to do so throughout the EU, and monitoring the quality of medicines and their manufacturing and distribution processes.
- Acting as competent authority for the implementation of EU and national legislation relating to blood, blood components, tissues, cells and medical clinical research, and cosmetics.
- Regulating medical devices on the Irish market.
Briefly outline how biologicals and combination products are regulated in your jurisdiction.
All medicinal products for human use derived from biotechnology and other high technology processes must be approved by the European Medicines Agency (EMA).
Regulations on the contained use or deliberate release of genetically modified organisms (GMOs) in Ireland are implemented by the Environmental Protection Agency.
Medical devices incorporating a medicinal product are regulated by the IMB under the medicinal products and medical devices legislation. They are classified as Class III (highest risk) devices and are therefore subject to high levels of compliance assessment. These devices must conform to the “essential requirements” of the medical devices legislation. The NSAI, in carrying out its conformity assessment, consults with the IMB in relation to the medicinal products before making a decision on its conformity assessment.
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This article first appeared in the Practical Law Multi-Jurisdictional Guide 2014/15 Life Sciences: Practical Law Company – Medicinal Product Regulation & Product Liability 2014 and is reproduced with the kind permission of the publisher Practical Law Company. The Q&A is part of the multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.Download PDF