Early access to medicines – how patients in Ireland can use 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 can get access to medicines that have not been approved yet in the following ways.  

Clinical trials 

Patients can join clinical trials to receive treatment with medicines being used in the trial. These are called investigational medicines. 

Investigational medicines in clinical trials don't need to be approved but must follow specific rules for quality and safety. The clinical trial must be approved by the HPRA.  

Doctors can help patients find suitable trials. Information is available from the EU Clinical Trials Information System. 

Expanded access programmes 

Expanded access programs allow patients to use medicines that haven’t been authorised yet. These programs let patients continue treatment if they have benefited from a medicine during a clinical trial. 

Expanded access or compassionate use programs don't need approval unless they are considered clinical trials.  

Otherwise, they fall under the exemption for individual patient use as prescribed by a healthcare professional. 

Prescription from a healthcare professional 

Irish law allows doctors and some other healthcare professionals to prescribe unauthorised medicines to meet the special medical needs of their patients. These unauthorised medicines are called exempt medicines because they are exempt from authorisation.  

Collecting and maintaining information about exempt medicines 

The HPRA doesn't keep records of patients treated with exempt medicines. 

The HPRA does not issue authorisations for exempt medicines because they have not yet been assessed for quality, safety and efficacy. However, wholesalers and manufacturers based in Ireland must notify the HPRA when they import exempt medicines to be used in Ireland. They also must report any side effects involving an exempt medicine to the HPRA.  

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