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Portugal has to suspend the sale of 111 generic medicines
Portugal will have to suspend the sale and cancel authorizations of 111 generic medicines tested by the Synapse Labs laboratory in India, following a recommendation made today in this regard by the European Commission to the Member States of the European Union (EU).
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País Synapse Labs
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for Portugal, includes 111 medicines from pharmaceutical companies such as Generis and Sandoz, which will have to be withdrawn or whose marketing should not be authorized, with the decision having been taken by the Community executive after a recommendation from the European Medicines Agency (EMA).
According to a statement from the Community executive, the issue is an EMA assessment of Synapse generics, following a request from the Spanish medicines agency, which concluded that there was no data or that it was insufficient to "demonstrate bioequivalence", which occurs when two medicines release the same active substance into the body at the same rate and to the same extent under similar conditions.
Brussels emphasizes that the EMA "has established that the tests carried out by Synapse Labs on these generic medicines did not meet the strict EU requirements to demonstrate that they are equivalent to the reference medicines".
In agreement with the 27 Member States, the statement emphasizes that national marketing authorizations will be suspended until manufacturers can provide valid and reliable data to demonstrate equivalence, that is, "provide data demonstrating that generic medicines release the same amount of active substance into the body as the reference medicines".
Lusa has already questioned the National Authority of Medicines and Health Products (Infarmed) for more information, but has not yet received a response.
Read Also: Infarmed reinforces transparency in the disclosure of reactions to medicines (Portuguese version)
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