Brazil: RDC No. 497/2021 – New Regulation on Certification of Good Practices

In brief

The Brazilian National Health of Surveillance Agency (“Anvisa“) published today (May 26) the Resolution RDC No. 497/2021 (“RDC 497/2021“) for providing for 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 June 1, 2021¹, and will revoke RDC No. 39/2013.

More details

Overall, RDC 497/2021 modifies the regulation related to the general conditions of certification, as provided for in its Chapter II, in order to facilitate the certification process. As an example, there is a new provision related to the analysis of certification petitions, which occurs in chronological order, unless the certification petition refers to a site which  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 been extended and now is four years counted from the date of its publication in the Federal Official Gazette, while the validity of the Good Manufacturing Practices Certificate remains of two years.

The new resolution defines that the following certification 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, having also brought the procedure for certification in the food manufacturing sector (products that were not regulated by RDC 39/2013):

• Food:
• Certification of Good Manufacturing Practices for International Industry; and
• Certification of Good Manufacturing Practices for Industry in the country.

Finally, it is worth noting that we did not identify prevision related to self-inspection in RDC 497/2021, a concept that was brought 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 be in force 06 (six) months after the resolution. This article provides that information about how the situation of companies will be disclosed at ANVISA’s database regarding the Good Practices certification.