New law allows Brazil’s veterinary vaccine industry to produce Covid-19 vaccine

RIO DE JANEIRO, BRAZIL – President Jair Bolsonaro sanctioned this Thursday (15), with a partial veto, Law No. 14187, of July 15, 2021, which authorizes veterinary vaccine manufacturing establishments in Brazil to produce immunizers against Covid-19 as well as the active pharmaceutical ingredient (API), provided they meet all the sanitary standards and biosafety requirements of establishments intended for the production of vaccines for human use.

The law published in the Federal Gazette this Friday (16) also provides that all phases related to production, bottling, labeling, packaging, and storage of vaccines for human use must be performed in physically separate facilities from those used for the manufacture of products for veterinary use.

The text also says that when there are no separate environments for storage, the vaccines against Covid-19 can be stored in the same storage area as the vaccines for veterinary use, upon prior evaluation and consent of the federal health authority, and further provided there is a methodology for identification and segregation of each type of vaccine.

Article 5 was vetoed by the President. The text would have permitted the government to offer a tax incentive for those legal entities that adapt their industrial structures – originally intended for the manufacture of products for veterinary use – for the production of vaccines against Covid-19.

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