Under the current system, the use of unauthorized medicines or the off-label prescribing of an authorized drug must be approved by the Spanish medicines agency, AEMPS, on a case-by-case basis. However, Spain has now chosen to simplify the system of drug approval.
According to the new procedures, the AEMPS will now establish certain protocols which will determine the criteria for prescribing an unauthorized medicine.
In addition, the AEMPS will no longer evaluate the off-label use of the drugs individually. In its place, a clinical practice or clinical data centers will develop specific protocols and evaluate the prescription for an unauthorized indication.