2. Early access

3.4. The role of the European Medicines Agency

On request by a MS the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) can provide recommendations to that MS on how to administer, distribute and use a medicine for compassionate use. It also identifies which patients may benefit from CUPs. It can also do so when it becomes aware that compassionate use programmes with a given medicine are being set up in a number of member states. Recommendations are optional for implementation by a MS, complement national legislation, and do not replace it or create any legal framework in the MSs. Instead, they aim to standardise compassionate use programmes across the European Union and may also help to clarify the conditions of existing compassionate use programmes. The EMA publishes on its website a list of opinions on the compassionate use of medicines that the CHMP has adopted. This registry also includes information on the EMA’s recommendations, such as the patients in whom the medicine can be used, and how it should be used.