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Argentina
WTW
Employers in Argentina should look closely at cost increases resulting from sweeping reforms that allow healthcare providers to adjust plans' premiums on their own terms.
Brazil
Koury Lopes Advogados
New Normative Instruction (IN), which comes into force in June, brings a list of equivalent foreign regulatory authorities approved by ANVISA and the requirements for optimized registration of medical devices...
Koury Lopes Advogados
Relatório destaca esforços do Brasil com treinamentos nos termos da convenção, mas revela preocupação com impunidade em casos de corrupção transnacional...
Koury Lopes Advogados
Em 12 de setembro de 2023, entrou em vigor a Lei nº 14.671, introduzindo a possibilidade de órgãos fiscalizadores do Sistema Nacional de Vigilância Sanitária (SNVS).
Koury Lopes Advogados
A Câmara dos Deputados aprovou nesta terça-feira (13/12) o Projeto de Lei nº 1998/2020, que define e regulamenta a prática da telessaúde no país, na forma do parecer do deputado Pedro Vilela...
Koury Lopes Advogados
Em 21.09.2022, foi publicada no Diário Oficial da União ("DOU") a Resolução de Diretoria Colegiada – RDC nº 751/2022, a qual atualizou os critérios de classificação de risco...
Colombia
WTW
A controversial healthcare reform proposal in Colombia that would shift control of healthcare system funding from private companies to the government is moving forward in the approval process.
Ecuador
CorralRosales
Mediante Resolución STFP-009-725-2023 de 15 de marzo de 2023 (la "Resolución"), el Consejo de Fijación y Revisión de Precios de Medicamentos de Uso y Consumo Humano (el "Consejo")...
CorralRosales
The Regulation STFP-009-725-2023 of March 15, 2023 (the "Regulation"), issued by the Board for Fixing and Reviewing the Prices of Medicines for Human Use and Consumption (the "Board")...
CorralRosales
The purpose of antimicrobial drugs is to combat diseases that can be of bacterial, viral and parasitic origin. But when they are misused or overused, these microorganisms...
CorralRosales
Mediante Decreto Ejecutivo No. 451 de 9 de junio de 2022 se reformó el Reglamento General de la Ley Orgánica del Sistema Nacional de Contratación Pública, en lo atinente a las disposiciones aplicables...
CorralRosales
Through Executive Decree No. 451, issued on June 9, 2022, the Regulations to the Public Procurement Law were amended. The amendment covers the provisions applicable to the acquisition of medicines...
Mexico
Mintz
New Mexico recently became the latest state to receive Centers for Medicare & Medicaid Services (CMS) approval to expand the state's behavioral health service offerings through mobile crisis intervention teams.
OLIVARES
On December 7th the Mexican regulatory agency COFEPRIS approved the marketing authorizations for the Pfizer and Moderna COVID-19 Vaccines.
OLIVARES
On May 30 of this year, the "Decree reforming, adding, and repealing various provisions of the General Health Law, to regulate the Health System for Welfare" came into effect...
OLIVARES
The shortage of medicines and the facilities provided by e-commerce have increased the sale of medicines that come from abroad, mainly through websites...
OLIVARES
On September 8, 2022 was published in the Official Gazette of the Federation, the Reform Bill by which several provisions to the Regulation on Advertising of the General Health Law are added and amended.
OLIVARES
Regarding Compulsory Licenses(CLs), the TRIPS Agreement is the "Bible; " it isn't everything, but it is the main legal frame.
OLIVARES
The primary legislation for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices is the General Health Law
Global Advertising Lawyers Alliance (GALA)
The Ministry of Health has issued the Resolution No. 414, published in Official Gazette No. 42,682 dated August 1, 2023, enacting a prohibition on the manufacture, storage, distribution, commercialization...
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