Text was approved by Jair Bolsonaro during hospitalization and is valid for veterinary immunization factories
even hospitalized in capital paulista, the president Jair Bolsonaro sanctioned this Friday, 16, the project that authorizes establishments manufacturing veterinary vaccines to produce immunization against the Covid-19. These manufacturers are also authorized to produce and the active pharmaceutical ingredient, the raw material used to produce vaccines. The proposal was approved by Congress on June 23 and was only awaiting presidential approval to take effect. According to the text, veterinary establishments will have to comply with the same sanitary and biosafety standards required of vaccine producers for human use. The proposal also provides for a separation between the production sites of immunizing agents for animal use and for human use. In practice, facilities within the same factory for the production, filling, labeling, packaging and storage of veterinary products must be physically separated from industrial structures intended for human use.
If it is not possible to separate the storage locations, establishments may place both types of immunization agents in the same enclosure, provided that there is authorization from the federal health authority and a methodology to differentiate veterinary and human vaccines. When sanctioning the proposal, the president vetoed some parts of the text that had been approved by Congress. Among them, what provided that an act of the Executive Power could grant tax incentives to companies that adapt industrial structures to produce vaccines against Covid-19. According to Palácio do Planalto, this section of the bill violates the Constitution, which determines that tax benefits can only be created by law in the strict sense. In addition, the fiscal incentive would result in forgoing revenues, which would make the task of meeting the fiscal target even more complicated for the federal government.
*With information from the reporter Antônio Maldonado