Our Committee for Socio-Economic Analysis (SEAC) has updated its approach for recommending review periods in its opinions on applications for authorisation. The new approach incorporates developments in opinion and decision-making processes over recent years. For example, substitution plans are now factored in in the evaluation of review periods.
If you are currently preparing or intend to prepare authorisation applications, read the new approach to learn what elements will be considered when your application is evaluated.