The list, for Portugal, includes 111 medicines from pharmaceutical companies such as Generis and Sandoz, which will have to be withdrawn or whose marketing should not be authorised, with the decision being taken by the community executive following a recommendation from the European Medicines Agency (EMA, in the English acronym).

At issue, according to a statement from the community executive, is an assessment by the EMA of Synapse's generics, following a request from the Spanish medicines agency, which concluded that there was no or insufficient data to “demonstrate bioequivalence”, which happens when two medicines release the same active substance in the body at the same rate and to the same extent under similar conditions.

Brussels reinforces that the EMA “established that the tests carried out by Synapse Labs on these generic medicines did not meet the EU's strict requirements to demonstrate that they are equivalent to reference medicines”.

In agreement with the 27 Member States, the statement highlights, that national marketing authorisations will be suspended until manufacturers can provide valid and reliable data to demonstrate equivalence, that is, “provide data that demonstrate that generic medicines release the same amount of active substance in the body as reference medicines”.