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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.

Author

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.

Author

Carla Moraes is an associate in Baker McKenzie Sao Paulo office, in partnership with Trench Rossi Watanabe.

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