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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
Petições que já tenham sido alvo de avaliação por autoridades passam a tramitar com mais agilidade perante a Anvisa, facilitando a regularização desses produtos...
Leão Advogados Associados
Scientific investigations conducted to expand knowledge and understanding of fundamental concepts in a given field of study are the core of basic research...
Koury Lopes Advogados
O TCU é competente para fiscalizar atos da União e das entidades da Administração Indireta sob os aspectos da legalidade e da economicidade.
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...
Koury Lopes Advogados
Em 24/02/2022, o Supremo Tribunal Federal ("STF"), por unanimidade, reconheceu a existência de Repercussão Geral no Agravo em Recurso Extraordinário nº 843989, agora registrado sob o Tema nº 1199.
Serviços médicos em farmácias: Augusto Simões e Pedro Henrique Pessoa têm artigo publicado no Conjur
Koury Lopes Advogados
Os advogados da área de Life Science, Augusto Simões e Pedro Henrique Pessoa, tiveram artigo publicado no Conjur. A temática abordada por eles diz respeito à prestação de serviços médicos nas farmácias...
Goodwin Procter LLP
On March 24, 2022, Celltrion Healthcare announced that it had won a bid to the Brazilian Federal Government to supply a biosimilar version of Remsima® (infliximab), along with bids to 12 Brazilian states.
Mexico
OLIVARES
The Ministry of Health and COFEPRIS released a document proposing a "Regulatory Certainty Strategy for the Pharmaceutical Sector: Biosimilars".
TMF Group BV
Gracias a su proximidad a EE.UU., sus sólidas capacidades de fabricación, su fuerza laboral calificada, su rentabilidad, la resistencia de su cadena de suministro y sus acuerdos comerciales, ...
TMF Group BV
Devido a sua proximidade com os EUA, grande capacidade produtiva, força de trabalho qualificada, eficiência econômica, adaptabilidade da cadeia de abastecimento e acordos comerciais abrangentes, ...
TMF Group BV
墨西哥毗邻美国，该国的制造业强大、劳动力熟练、成本效益高、供应链坚韧且贸易协定全面，因此正在引领新的近岸外包（即在国内市场附$
OLIVARES
More than 20 years ago the Decree Reforming the Regulation of Supplies for Health and the Regulation
of the Industrial Property Law was published in Mexico.
TMF Group BV
With its proximity to the USA, robust manufacturing capabilities, skilled workforce, cost-efficiency, supply chain resilience and comprehensive trade agreements...
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
OLIVARES
Patent term compensation is a legal procedure whose nature and purpose is to adjust the reduction in the effective enforcement of the exclusive rights of the patented invention...
OLIVARES
The primary legislation for the advertising of medicinal products is the General Health Law (Ley General de Salud) (HL) and its Regulations (Reglamento de la LGS en Materia de Publicidad) (HLR).
Foley & Lardner
The Mexican Federal Commission for the Protection Against Sanitary Risks (Cofepris) and the Federal Consumer Prosecutor's Office (Profeco) removed more than 10,000 units of domestic...
OLIVARES
The decree published in the Official Gazette of the Federation on Sept. 19, 2003, added section IV of article 167 and article 167 bis of the Health Supplies Regulation were added...
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