• Our partner Marcos L. Freitas Levy presents the main new standards published by ANVISA in November.

    (more…)

  • Our partner Marcos L. Freitas Levy presents the main new standards published by ANVISA in October

    (more…)

  • Main New Norms Published by ANVISA – September 2023

    Our partner Marcos L. Freitas Levy presents the main new standards published by ANVISA in September.

    (more…)

    Read More

  • Main New Norms Published by ANVISA – August 2023

    NORMATIVE INSTRUCTION – 241/2023, that amends Nomative Instruction 162/2022, that specifies the acceptable daily ingestion (IDA), the acute reference dose (DRfA) and the maximum residue limits (LMR) for active ingredients of veterinary medicines, in food of animal origin.

    Updating of the “Reference Medicine” list, for the purposes of Resolution RDC 35/2012 RESOLUTION – RDC 808/2023, that amends RDC 768/2022, containing the new Regulatory Framework for labeling of Medicinal Products.

    RESOLUTION – RDC 807/2023, that regulates the importation of goods and services subject to sanitary surveillance through the Single Import Declaration (Duimp).

    ORDINANCE 863/2023, that sets forth the competences and procedures for the review and consolidation of normative acts, under the level of Decree, within the National Sanitary Surveillance Agency – ANVISA.

    ANVISA and the State of São Paulo, enter into a collaboration agreement in the area of pharmacovigilance, with the use by the State of São Paulo, of the “VigiMed System”, for the notification of medicines related adverse events.

    RDC 809/2023, that amends RDC 585/2021, that approves and enacts the By-laws of ANVISA. Ordinance 875/2023 that creates the Technical Chamber of Medicines Registration (CATEME).

    CATEME’s purpose is to perform technical studies and issue recommendations related to the registration of medicines and biological products, to serve as a source of technical guidance to help in the procedure for evaluation and decision making in the scope of the registration of these products and of clinical research.

    RESOLUTION – RDC 810/2023, that amends RDC 751/2022, that regulates the risk classification, the notification and registration notices, and the labeling requirements and use instructions of medical devices.

    RESOLUTION – RDC 811/2023, that amends RDC 204/2017, that regulates the fitting within the priotity category, of petitions for registration, post´registration, and previous consent in medicines clinical studies, and amends RDC 205/2017, that sets forth special procedures for consent in clinicas studies, certification of good manufacturing practices, and registration of new medicines for treating, diagnosing, and preventing rare diseases.

    NORMATIVE INSTRUCTION – IN 244/2023, taht defines the list of substances classified as prescription antimicrobian, isolated or in association, as regulated under RDC 471/2021.

    First edition of the Questions & Answers (Q&A) about activities related to clinical analysis tests that can be performed in pharmacies.

    Read More

  • Main New Norms Published by Anvisa – July 2023

    ORDDINANCE 802/2023, that creates the tri-party work group to manage the National Sanitary Surveillance System (SNVS), to standardize and harmonize procedures, actions, programs, plans and, parameters of activities related to the Sanitary Surveillance Notification and Investigation System (VIGIPÓS) in post commercialization and post use.

    RESOLUTION – RDC 802/2023 that regulates use of restricted or prohibited use pharmaceutical inputs, in human use medicines.

    RESOLUTION – RDC 803/2023, that updates the list of Brazilian Common Denominations (DCB)

    RESOLUTION – RDC 804/2023, that updates Annex I of Ordinance 344/1998 (List of Narcotic. Psychotropic, Precursor Substances and others under Special Control)

    RESOLUTION – RDC 805/2023, that revokes 15 RDCs published between 2020 and 2022, related to the Public Health National Emergency (ESPIN) and to the Public Health International Emergency(ESPII), arising from the new coronavirus human infection (2019-nCoV)

    Read More

  • Chambers and Partners: Pharmaceutical  Advertising 2023

    The 2023 edition of the Chambers Pharmaceutical Advertising Global Practice Guide was published.

    This practical guide presents, in a concise and clear manner the regulations applicable to the advertisement of pharmaceutical products in different countries. Access the complete guide at: Pharmaceutical Advertising Global Practice Guide

    Read More

  • Corporate Newsletter | Annual Account Approval of Brazilian limited liability companies and corporations

    Annual Account Approval of Brazilian limited liability companies and corporations

    (more…)

    Read More

  • Corporate Newsletter | Statement of Brazilian Capital Abroad

    Statement of Brazilian Capital Abroad (“CBE”) before the Brazilian Central Bank (“BACEN”)

    (more…)

    Read More