03/11/2021
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 GBP 99. 1. Are there proposals for reform or significant change to the healthcare system? In 2020, the onset of the Covid-19 global pandemic wreaked havoc on healthcare systems worldwide. Ireland, like many other countries had to adapt quickly and provide safeguards…
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 GBP 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 GBP 99. 1. What types of liability are recognized in your jurisdiction? There are four main sources of product liability in Ireland: Statute The Liability for Defective Products Act 1991 transposed the EU Product Liability Directive 85/374/EC and is the…
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 GBP 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. Applications to…
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 GBP 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 GBP 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 GBP 99. 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The regulatory authority with responsibility for drugs, biologicals and medical devices in Ireland is the Health Products Regulatory…
An insight into traditional medicines and OTC products in Ireland.…
Key legal info on regulatory reform in Ireland. Prepared in…
A brief overview of the situation regarding preclinical and clinical…
The low-down on the situation regarding product liability in Ireland.…
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