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Portugal will have to suspend the sale and cancel authorizations of 111 generic drugs tested by Synapse Labs in India, following a recommendation made today by the European Commission to the member states of the European Union (EU).
The list for Portugal includes 111 drugs from pharmaceutical companies such as Generis and Sandoz, which will have to be withdrawn or their commercialization not authorized, with the decision being made by the community executive following a recommendation from the European Medicines Agency (EMA, in its English acronym).
At issue, according to a statement from the community executive, is an evaluation by the EMA of Synapse’s generics, following a request from the Spanish medicines agency, which concluded that there was no data or that the data were insufficient to “demonstrate bioequivalence,” which occurs when two drugs release the same active substance in the body at the same rate and to the same extent under similar conditions.
In agreement with the 27 member states, the statement underlines, national marketing authorizations will be suspended until manufacturers can provide valid and reliable data to demonstrate equivalence, i.e., “provide data that demonstrate that the generic drugs release in the body the same amount of active substance as the reference drugs.”
Lusa has already questioned the National Authority for Medicines and Health Products (Infarmed) to obtain more information, but has not yet received a response.
Portugal has to stop the sale of 111 generic drugs
Brussels reinforces that the EMA “established that the tests carried out by Synapse Labs on these generic drugs did not meet the strict EU requirements to demonstrate that they are equivalent to the reference drugs”.
