Introduction

On March 2nd, 2022, the new Resolution RDC No. 606 from ANVISA was published in DOU No. 41. This resolution, effective as of February 23rd, 2022, defines the criteria and procedures for extraordinary and temporary requests for the Certification of Good Manufacturing Practices. This is aimed at facilitating the registration and post-registration changes of active pharmaceutical ingredients, medicines, and health products due to the international public health emergency caused by the new Coronavirus. The procedures established in this Resolution apply specifically to petitions for Good Manufacturing Practices Certification.

Key Features

Temporary and emergency requests are included in the Resolution. Notably, the existence of remote inspection mechanisms is allowed, which can replace the on-site sanitary inspection necessary for the Certification of Good Manufacturing Practices.

Petition Classification

Petitions related to Temporary Certification can be classified as priorities.

Certification Validity

The validity of the Good Manufacturing Practices Certification is granted under the terms of Article 3 or Article 4 of this Resolution and lasts for two years from the date of its publication in the Official Gazette of the Union.