Client Alert
29/12/2022
ANPD releases new form for Security Incident Reports
On December 23, 2022, the Brazilian National Data Protection Authority ("ANPD") released a new sample form for security incident reports to be used after January 23, 2023.
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Client Alert
29/12/2022
Anvisa opens a Public Consultation to propose authorization for the skinny label practice
As previously informed in the client alert sent on December 23, Anvisa opened a Public Consultation (PC 1,137/2022) 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.
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Client Alert
28/12/2022
State of Pernambuco mandates take-back schemes for packaging
Foi publicado em 24/12/2022 o Decreto Estadual nº 54.222/2022, que define as diretrizes para a implementação, a estruturação e a operacionalização do sistema de logística reversa de embalagens em geral no Estado de Pernambuco.
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Client Alert
23/12/2022
New Federal Decree on the take-back of glass packaging
Foi publicado no Diário Oficial da União de 22/12/2022 o Decreto Federal nº 11.300/2022 que disciplina a logística reversa de embalagens de vidro.
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News
23/12/2022
Souto Correa advised Aegea in the privatization auction of Corsan
Souto Correa assessorou a Aegea no leilão de desestatização da Corsan, concessionária responsável pelos serviços de abastecimento de água e esgotamento sanitário em 317 Municípios do Rio Grande do Sul e atendimento de mais de 6 milhões de habitantes.
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Client Alert
23/12/2022
Anvisa’s Board of Directors approved the opening of a Public Consultation to propose authorization for the skinny label practice
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.
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Client Alert
21/12/2022
Term of reference for waste management plans in São Paulo state
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.
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News
14/12/2022
Souto Correa advised Cotribá on offering of Certificates of Real Estate Receivables (CRI)
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.
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Client Alert
02/12/2022
ANVISA opens public consultation aiming at speeding up the approval of clinical trials for rare diseases
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.
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Client Alert
02/12/2022
ANVISA has published a Resolution that could bring more agility in the assessment of clinical trials for rare diseases
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.
