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.
In Focus
Client Alerts
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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.
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Client Alert
17/11/2022
Double damages in cartel cases
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.
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Client Alert
03/11/2022
New proposals for federal decrees on the take-back of metal and paper/carboard packaging
One day before the end of the public consultation on a proposal for a federal decree regulating plastic packaging take-back, the Ministry of Environment launches two public consultations on decrees to regulate the take-back of paper and cardboard packaging (Ordinance No. 268/2022, Portuguese only) as well as metal packaging (Ordinance No. 269/2022, Portuguese only).
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Client Alert
03/11/2022
New regulation on the chemicals controlled by Brazil’s Federal Police
The Brazilian Ministry of Justice and Public Security (MJPS) has issued Ordinance No. 204/2022 (Portuguese only) establishing the procedures to control and inspect chemical products as well as defining the chemicals that are to be controlled by the Federal Police.
