S.L. 458.35 Art. 53Signal detection.

Regarding medicinal products authorised in accordance with Directive 2001/83/EC as amended, the Authority in collaboration with the Agency shall take the following measures:

(a) monitor the outcome of risk minimisation measures contained in risk management plans and of the conditions referred to in Articles 21a, 22 or 22a of Directive 2001/83/EC as amended;

(b) assess updates to the risk management system;

(c) monitor the data in the Eudravigilance database to determine whether there are new risks or whether risks have changed and whether those risks impact on the risk-benefit balance.