The Portuguese list includes 111 medicines from pharmaceutical companies such as Generis and Sandoz, and was approved by the European Medicines Agency (EMA).Electronic(The English acronym is ).
According to a statement from the Community Executive, what is at issue is the EMA’s evaluation of Synapse’s generic version at the request of the Spanish Medicines Agency, which concluded that there was no or insufficient data to prove “bioequivalence,” which occurs when two medicines release the same active ingredient at the same rate and extent under similar conditions in the body.
Brussels stressed 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 their equivalence to the reference medicinal product.”
The statement stresses that, in accordance with agreement with the 27 Member States, national marketing authorisations will be suspended until the manufacturer can provide valid and reliable data proving equivalence, i.e. data demonstrating that the generic medicinal product releases the same amount of active substance in the body as the reference medicinal product.
