The National Health Surveillance Agency (ANVISA) recently rejected a request for a Certificate of Good Manufacturing Practices from Brazil's largest pharmaceutical company-EMS.
Good Manufacturing Practices are recommended with the purpose of safeguarding the health of patients and for producing good quality medicine, medical devices or active pharmaceutical products.
ANVISA adopted this measure one month after having cordoned off manufacturing operations in one of EMS' facilities and suspended the manufacture of two important generic antibiotic drugs, Amoxicilina and Rifamicina.
In the case of Amoxicilina, ANVISA affirmed that the pharma company had been using a substance which did not obtain regulatory approval and, synthesizing another in a different mode than that submitted to the Agency. Moreover, it was detected that EMS' storage facilities did not meet the required environmental conditions.
The absence of the Certificate attesting to Good Manufacturing Practices precludes EMS from participating in Tender Offers/Government Bids but paradoxically, the company will be allowed to sell drugs to local Pharmacies and drug stores.
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