23/12/2022
At the last meeting of 2022, held on December 22, Anvisa’s Board of Directors approved a Public Consultation to amend Resolution-RDC 47/2009 - which sets forth rules for the elaboration, harmonization, updating, publication, and availability of labels of medicines for patients and health care professionals.
21/12/2022
A Companhia Ambiental do Estado de São Paulo (Cetesb) editou a Decisão de Diretoria nº 130/2022/P, que estabelece o termo de referência para a elaboração de PGRS no âmbito do licenciamento ambiental paulista.
14/12/2022
Souto Correa advised Cooperativa Agrícola Mista General Osório (Cotribá) on the public offering of Certificates of Real Estate Receivables (CRI) issued by True Securitizadora for BRL 94 million, backed by commercial notes issued by the Cooperative. Ingrid Hessling and Gabriella Souza, from the Capital Markets team, have coordinated the operation, which was structured by Banco Modal.
02/12/2022
On 09/14/2022, ANVISA’s Board of Directors approved a Public Consultation to review the rule that sets forth mandatory pre-submission meetings for clinical trials under the current wording of RCD 205/2017.
02/12/2022
On 12/01/2022, ANVISA published RDC 763/2022, revising RDC 205/2017 – which provides the procedures for approval of clinical trials, certification of GMP and marketing approval of new drugs for treatment, diagnosis or prevention of rare diseases.
01/12/2022
A Anvisa vem trabalhando para centralizar suas rotinas em um único sistema - Solicita. Este mês, o plano de ação envolve a migração de processos da Gerência Geral de Tecnologia de Produtos para Saúde – GGTPS.
28/11/2022
A Practice Note providing an overview of key issues for foreign counsel of a manufacturer or supplier of goods to consider when entering into an agency arrangement for the sale or purchase of goods and services in Brazil, including applicable laws and regulations, important considerations for appointing an agent, key provisions in agency agreements, and termination considerations.
25/11/2022
A Practice Note providing an overview of the key legal and commercial considerations for foreign counsel to consider when advising clients on establishing a franchising arrangement in Brazil, including applicable laws and regulations, key provisions in the franchise agreement, and termination considerations.
24/11/2022
On 22 November 2022, the Central Bank of Brazil (‘CBB’) published Normative Instruction (‘NI’) No. 325, which defines the accounting of sustainability assets such as Carbon Credit and Decarbonisation Credit certificates into the chart of accounts of the Accounting Standard of Institutions Regulated by CBB.
17/11/2022
On November 17, 2022, Law No. 14,470/2022, which implemented changes to certain provisions of Law No. 12,529/2011 (the Brazilian Competition Act), was published.