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Brazil: RDC No. 497/2021 – New regulation on certification of good practices

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In brief

On 26 May, the Brazilian National Health Surveillance Agency (“Anvisa“) published Resolution RDC No. 497/2021 (“RDC 497/2021“) setting forth the new administrative procedure for obtaining the Good Manufacturing Practices Certificate, as well as the Good Distribution and/or Storage Practices Certificate. This resolution will be in force from 1 June 2021¹ and will revoke RDC No. 39/2013.

RDC 497/2021 modifies the general conditions for certification, as provided for in its Chapter II, to facilitate the certification process. For instance, RDC 497/2021 has a new provision that allows the analysis of certification petitions to be conducted in non-chronological order if the certification petition refers to a site that will be subjected to a similar inspection request scheduled by another applicant or a Company connected to another petition that has a deadline for completion defined in a specific resolution.

The validity of the Good Distribution and/or Storage Practices Certificate has also been extended to four years counted from the date of publication in the Federal Official Gazette, while the validity of the Good Manufacturing Practices Certificate remains at two years.

Under the new resolution, the following certifications of good practice are liable for the petitioning procedure: (i) Certification of Good Practices in the country, and (ii) Certification of Good Practices in other countries. The procedure also covers certification in the food manufacturing sector (specifically for products not regulated by RDC 39/2013):

  • Food:
    • Certification of Good Manufacturing Practices for International Industry
    • Certification of Good Manufacturing Practices for Local Industries

Finally, it is worth noting that we did not find any provision related to self-inspection in RDC 497/2021, a concept that was introduced by RDC 39/2013 by ensuring that “evidence of self-inspection should be available during the sanitary inspection.”

1. Except for Art. 41, which will enter into force six months after the resolution. This article provides information about how companies’ Good Practices certification status will be disclosed on ANVISA’s database.

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“Trench Rossi Watanabe and Baker McKenzie have executed a strategic cooperation agreement for consulting on foreign law.”

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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.

Author

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.

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