One of the aims of the EU Clinical Trials Directive, introduced in 2004, was to simplify and harmonise the administration of clinical trials of investigational medicinal products across the EU member states by establishing clear, transparent procedures. Despite this, the regulatory path to be followed in order to enable sponsors to obtain full approval to initiate their studies still varies considerably throughout Europe. This is largely in part due to the different Ethics Committee and Local Site Specific approval requirements in the individual member states. Expert knowledge and insight into the required processes and procedures to be followed in the country in which you wish to conduct your clinical trial is critical in expediting the review process and avoiding unnecessary delays. Applying to the Irish Medicines Board for approval of trials in Ireland is no exception. Here we provide you with an overview of the regulatory path to be followed in Ireland, to give you an insight as to what is required to ensure a timely approval of your study.