Therefore, if EMA decides to respond to the medicine developer in writing, patients are asked to provide comments; if EMA decides to meet with the medicine developer, patients are invited to attend.
In the evaluation phase, patients are involved as experts to provide their views whether the medicine can address their needs.
Even at a national and regional level patient get involved in the consultations related to the medicine, in the context of the national health system of the respective country. Based on the same, the national authority takes decisions about the pricing and reimbursement.
Once the medicine is marketed, patients provide side effects reports which are continuously assessed and monitored. A dedicated EMA committee is responsible of this monitoring an,dmakes sure that a quick reaction and action is implemented should any issue is detected, in order to protect the patients.
The booklet is available on the EMA website.