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Brazil: The National Health Surveillance Agency publishes a new resolution regarding the recall of drugs

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In brief

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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His area of expertise is Public Law, Government Affairs and Regulatory, with focus on consultancy matters. Mr. Frizzo is recognized by Chambers & Partners as a leading Individual in Public Law. He elaborates legal opinions and responds to consultations on the areas of expertise, including public tenders and contracts with the government, concession and public-private partnership contracts. Has experience in complex negotiations with the government and in the alignment of strategies to meet the local content requirements in public tenders. Assist clients in the regulatory area, especially pharmaceutical, medical devices and health areas. Also acts in procurements in the defense area, including the negotiation of offset arrangements. He is a speaker in events related to compliance in contracts with the government and regulatory. Trench Rossi Watanabe and Baker McKenzie have executed a strategic cooperation agreement for consulting on foreign law.

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Carla Moraes is a Senior 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.

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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.

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