03/02/2020
Key legal info on regulatory reform in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for USD 99. 1. Are there proposals for reform or significant change to the healthcare system? In Ireland, there is currently no mechanism for class actions; however, the Multi-Party Action Bill 2017 is making its way through the legislative system. If this piece…
Want to know more about patents & trademarks in Ireland? Read on! Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for USD 99. 1. What are the basic requirements to obtain patent and trademark protection? Patents The requirements to obtain patent protection are outlined on the website of the Intellectual Property Office of Ireland (IPOI). Any person can make…
The low-down on the situation regarding product liability in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for USD 99. 1. What types of liability are recognized in your jurisdiction? There are four different sources of product liability available in Ireland and these are as follows: Statute The Liability for Defective Products Act (1991) transposed EU Product Liability…
An insight into traditional medicines and OTC products in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for USD 99. 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional, herbal, complementary or alternative medicines and devices on the Irish market must be either authorised or registered with the HPRA which, as…
All about marketing, manufacturing, packaging & labeling, advertising in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for USD 99. 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? See Question 1 of Regulatory, Pricing and Reimbursement Overview. 2. What is the authorization process for…
A brief overview of the situation regarding preclinical and clinical trial requirements in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for USD 99. 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials do not have to be conducted locally in order to gain marketing approval in…
An intro to the legal situation for regulatory, pricing and reimbursement in Ireland. Prepared in association with Mason Hayes & Curran, a leading law firm in Ireland, this is an extract from The Pharma Legal Handbook: Ireland, available to purchase here for USD 99. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authority in Ireland for drugs, biological and medical devices in Ireland is known as the Health…
An insight into traditional medicines and OTC products in Ireland.…
Want to know more about patents & trademarks in Ireland?…
Key legal info on regulatory reform in Ireland. Prepared in…
A brief overview of the situation regarding preclinical and clinical…
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