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.
In Focus
Client Alerts
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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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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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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.
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Client Alert
01/12/2022
Modification in the electronic submission system for Medical Devices
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.
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Client Alert
24/11/2022
Central Bank standardises the registration of carbon credits by financial institutions
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.
