Early access to medicines – how patients in Ireland may be able to access medicines before they are authorised
In Ireland, medicines need to be authorised before a patient can use them.
Sometimes, there is no authorised medicine available to treat a patient’s illness or to meet their medical needs. When this happens, a patient may be able to get access to medicines in the following two ways.
Clinical trials
Patients may be able to join a clinical trial to receive treatment with medicines being used in the trial. These trial medicines are called ‘Investigational medicines’. Clinical trials must be approved by the HPRA.
Exempt medicinal products
Medicines placed on the Irish market must be authorised by the HPRA or the European Medicines Agency. However, there is an exemption to this rule where an authorised medicine is not available.
Medicines not authorised in Ireland, but which are authorised outside of Ireland, may be supplied in cases where a registered healthcare professional (doctor, dentist, nurse prescriber or midwife prescriber) has prescribed the product for a patient under their direct responsibility in order to fulfil the needs of the patient.
In Ireland these products are called exempt medicinal products (EMP).
Related information
Search the clinical trials database for information on the illnesses being targeted. trial locations, and sponsor contact details.
Learn moreWholesalers and manufacturers must notify the HPRA when importing these medicines. They must also report side effects.
Learn more