EMA is a scientific body with the expertise required to assess the benefits and risks of medicines. However, under EU law it has no authority to actually permit marketing in the different EU countries. The role of EMA is to make a recommendation to the European Commission which then takes a final legally binding decision on whether the medicine can be marketed in the EU. This decision is issued within 67 days of receipt of EMA’s recommendation. The Commission is thus the authorising body for all centrally-authorised products.
Commission decisions are published in the Union Register of medicinal products for human use.