02/01/2023
On December 28, 2022, Law No. 14,510/2022 (Telehealth Act), which authorizes the practice of Telehealth throughout the Brazilian territory, came into force. After lengthy discussion and approval by Congress, the President sanctioned the final wording of the Bill of Law 1,998/2020 without vetoes.
30/12/2022
The Provisional Measure nº 1.150 (Portuguese only) published on 12/26/2022, amending article 59 of the Forest Code and establishing a deadline of 180 days for the rural landowners or possessors to submit to the Environmental Regularization Program ("PRA"), as of the subpoena from the competent body.
29/12/2022
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.
29/12/2022
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.
28/12/2022
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.
23/12/2022
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.
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.
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.