Yesterday, the National Health Surveillance Agency (ANVISA) published Resolution RDC No. 625/2022, which provides the minimum requirements related to the marketing authorization holders’ obligation to communicate the implementation of a drug recall to the competent authorities and consumers. This is in case there is sufficient evidence or proof of quality deviation resulting in risks or consequences to health, as well as due to the cancellation of registration related to safety and efficacy.
The new resolution, which will come into force on 1 April 2022, will revoke the current Resolution RDC No. 55/2005. Articles now provide for information that must be included: (i) in each of the forms to be sent to ANVISA; (ii) in the messages to be sent to consumers; (iii) in the distribution map of the drug to be recalled, which must be sent to the registration holder by the distributors; as well as (iv) in the monitoring reports. The old forms attached to RDC No. 55/2005 will be excluded.
In addition, Resolution RDC No. 625/2022 now provides the possibility that the provisions related to a voluntary recall are applicable to the recalls determined by ANVISA.
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Henrique Kruger Frizzo joined the firm in 2004 and became a partner in 2014. He is the leader of the Life Sciences group and also integrates the Public and Regulatory Law group. He acts in the preparation of legal opinions and consultations on topics of his expertise, including tenders and contracts with the government, public service concession contracts and public-private partnerships. He has experience in complex negotiations with the government and assists clients in structuring effective government relationships. He also acts in the identification of irregularities and illicit acts in contracts and relationships with the government and in the area of sales to defense and public security agencies, including in the structuring of technological compensation agreements.
In the Healthcare sector, he advises pharmaceutical, medical device and other companies in the sector on a wide range of matters, including transactions involving commercial agreements and complex negotiations with the government and health technology transfer agreements. He also advises clients on market access strategies, including procedures for the incorporation of new health technologies into SUS and ANS, and represents companies in CMED administrative proceedings. Henrique prepares consultations involving clinical research and regulatory issues, reviews promotional materials, and acts in administrative litigation involving local health authorities and ANVISA. Additionally, he provides support in compliance issues, digital health and analysis of the constitutionality/legality of legislation. Due to his expertise, he participates in the drafting of bills of law and regulations for the industry.
In Public Law, Government Affairs, Regulatory and Compliance, he has extensive experience in corporate investigations, with a focus on government procurement and corruption, and their respective consequences in the civil and administrative areas. We assist clients in defining strategic decisions regarding the results of the investigation and participate in the defense before or during the negotiation with the civil and administrative police authorities responsible for the cases.
Carla Bacchin Fernandes de Moraes Cox associou-se ao escritório em 2012. Sua área de especialização é em Direito Público e Direito Regulatório, com foco em consultivo e contencioso administrativo. Auxilia clientes na área regulatória, especialmente na área de saúde/sanitária, com atuação perante a Agência Nacional de Vigilância Sanitária – ANVISA , Comissão Nacional de Ética em Pesquisa – Conep, Câmara de Regulação do Mercado de Medicamentos – CMED, Ministério da Agricultura, Secretarias Estaduais de Saúde e vigilâncias sanitárias municipais. Atua na elaboração de pareceres e consultas sobre os temas de sua especialização, incluindo licitações e contratos com o governo. Além disso, Carla é membro da Comissão de Bioética e Biodireito da OAB.
Juliana Reis is an Associate in Trench, Rossi e Watanabe Advogados, Sao Paulo office. Trench Rossi Watanabe and Baker McKenzie have executed a strategic cooperation agreement for consulting on foreign law.
