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 by 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 (EMP)
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 where a registered doctor, registered dentist, registered nurse prescriber or registered mid-wife prescriber has prescribed the product for a patient under their direct responsibility in order to fulfil the needs of the patients. In Ireland such products are called 'exempt medicinal products' (EMP)
Related Information
Find a clinical trial in Ireland
Search the clinical trials database for information on the illnesses being targeted. trial locations, and sponsor contact details. Learn more
Notifications for exempt medicines
Wholesalers and manufacturers must notify the HPRA when importing these medicines. They must also report side effects. Learn more
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