President Jair Bolsonaro sanctioned this Thursday (15), with a veto, the Law No. 14187, of July 15, 2021, which authorizes establishments manufacturing veterinary vaccines to produce immunization agents against covid-19 and the active pharmaceutical ingredient (IFA) in Brazil, provided they comply with all sanitary standards and biosafety requirements specific to establishments intended for the production of vaccines for use human.
The law published in Official Diary of the Union this Friday (16) also provides that all phases related to the production, packaging, labeling, packaging and storage of vaccines for human use must be carried out in facilities physically separate from those used for the manufacture of products intended for use vet.
The text also says that, when there are no separate environments for storage to be done, vaccines against covid-19 may be stored in the same storage area as vaccines for veterinary use, upon prior evaluation and consent of the federal health authority and since that there is a methodology for identifying and segregating each type of vaccine.
Article 5 was vetoed by the President of the Republic. The text establishes that the Executive’s act could provide fiscal incentives for legal entities that adapt their industrial structures originally intended for the manufacture of veterinary products for the production of vaccines against covid-19.
“Although the good intention of the legislator in authorizing a tax benefit is recognized, the legislative proposal would face a legal obstacle for violating a provision in the Constitution of the Republic that determines that tax benefits can only be created by law in the strict sense”, says the document.
Also according to the justification for the veto, “the proposal for legislation would entail waiver of revenue without presentation of the estimated budgetary and financial impact and compensatory measures, in violation of the Fiscal Responsibility Law and the 2021 Budget Guidelines Law”.
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