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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
A empresa, que se dedica à fabricação de alimentos congelados, considerou que os materiais de embalagem são essenciais para o processo produtivo e à sua atividade principal.
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.
Tauil & Chequer
Em 3 de janeiro de 2022 foi publicada a Lei 14.289 que dispõe sobre o sigilo acerca da condição de pessoas com infecção pelos vírus da HIV, HBV, HCV, hanseníase e com tuberculose.
Koury Lopes Advogados
Durante a pandemia, fomos obrigados a revisitar os princípios da universalização do acesso à saúde.
Mexico
OLIVARES
In recent years, we have witnessed a legislative trend in various countries that consists of incorporating provisions aimed at implementing front labeling systems for food and non-alcoholic...
OLIVARES
The primary legislation for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices is the General Health Law
OLIVARES
Health companies are using Latin America´s largest last-mile app, Rappi, to book at-home medical services with certified health workers to conduct them.
OLIVARES
Also, on May 31, "World Tobacco Day," the president of Mexico issued a decree regarding vapes and electronic cigarettes use in the country, which came into effect immediately.
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).
OLIVARES
Mexican legislation has not specifically defined "digital health". However, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and other private and public entities...
OLIVARES
COFEPRIS, the Mexican sanitary agency, has finally decided to continue working in a digital platform that would allow the conclusion of several procedures in "minutes" rather than months.
OLIVARES
The Pharma Legal Handbook answers essential questions about the environment for pharmaceuticals in Mexico. It is a must have for any company operating in the country or looking to enter the market.
OLIVARES
After more than 10 years, the official standard of good manufacturing practices concerning medical devices has been updated. On December 20, 2021...
Chevez Ruiz Zamarripa
El 22 de octubre de 2021 se publicó en la edición vespertina del Diario Oficial de la Federación (DOF) por la Secretaría de Economía (SE), el "DECRETO por el que se modifica la Tarifa...
OLIVARES
A Decree was published on June 22, 2021. Said decree amended the so-called Equivalence Decree published back on January 28, 2020 in the Federal Official Gazette by the Ministry of Health
OLIVARES
Last May 31, 2021, the Ministry of Health issued a decree in the Official Gazette, amending several articles of the Health Law Regulations.
Puerto Rico
Goodwin Procter LLP
Last week, OcyonBio announced a manufacturing and operations agreement to develop biosimilar drug product facilities for Biosimilar Solutions, Inc. in Puerto Rico.
Littler Mendelson
On July 22, 2021 the Puerto Rico Department of Health (PRDOH) issued Administrative Order No. 2021-509 (AO) providing that, in order to physically attend school...
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