Anvisa adopts measured emergenciais for vaccines against Influenza

The Direction Student body of the Anvisa today approved a Resolution that establishes emergencial rite for the vaccine production Influenza A (H1N1) in Brazil. In accordance with the RDC, that will be published in Federal official gazette in the next one fifth, day 7, is authorized previously the vaccine manufacture, distribution and commercialization Influenza A (H1N1) in Brazil since that taken care of the following requirements: 1- The manufacture alone could be made by detainers of register in Brazil and possessors of respective plants manufacter. 2- The manufacturers already must possess vaccine register against Influenza and be duly authorized for the Anvisa. 3- The Resolution is applied only to the vaccine production from cepa viral Influenza A (H1N1) supplied by the World-wide Organization of the Health. 4- The Anvisa will have formal to be communicated by the detainer of register and/or manufacturer, immediately after the act of receiving of cepa for production of the vaccine. All the process will be folloied by a Committee Regulatory Technician formal consisting. Qualified laboratories In Brazil, seven laboratories withhold the register to produce vaccines against the Influenza. Of these, only one is public: the Butantan Institute, in São Paulo.
Information: Ascom/Assessorship of the Press of the Anvisa