Public consultations on relevant themes launched – The Brazilian Health Regulatory Agency (ANVISA) opened six public consultations regarding themes such as the labelling and package leaflet of medicinal products , products linked to dietotherapy for metabolic diseases, and the use of authorized solvents in food and ingredients production

  • Three Public Consultations address standards for labelling and package leaflet of medicinal products. Public Consultation n. 815/2020 deals with the revision of the Collegiate Directorate Resolution (RDC) n. 71/2009, on drug labeling rules. Public Consultation n. 816/2020 proposes a Normative Instruction (IN) with specific requirements for drug labels. Public Consultation n. 817/2020 revises RDC n. 137/2003, which establishes alert sentences for substances and/or therapeutic classes in medicine package labels and leaflets. Contributions can be sent until September 7, 2020.
  • Public Consultation n. 820/2020 and Public Consultation n. 821/2020 refer to dietotherapic formulas (individually adapted balanced diet) for innate (congenital) errors of metabolism. They propose specific rules to ensure the quality and safety of products intended for consumption by people with these diseases and who necessarily have restrictive diets, especially newborns and children. The contribution deadline is September 21, 2020. 
  • Public Consultation n. 822/2020 addresses a proposed resolution on extraction and processing solvents authorized for use in the production of food and ingredients. The regulatory intervention aims to update the list of authorized extraction and processing solvents used in the production of food and ingredients, expanding the inventory of approved substances and defining the maximum residue limits tolerated in the final product, so as not to cause damage to the consumer’s health. According to ANVISA, it will be available for contributions until September 21, 2020.