Published resolution of Good Manufacturing and Importing Practices for Drugs and Pharmaceuticals Inputs

ANVISA published (May 28) the Resolution RDC No. 392/2020 for defining extraordinary and temporary criteria and procedures for flexing certain specific requirements applicable to the Good Manufacturing Practices and Import of Pharmaceutical Inputs, due to the Coronavirus pandemic.

According to the RDC, exceptional and temporally, manufacturers and importers of drugs and pharmaceutical inputs may disregard the Good Practices technical requirements that may – through formally documented risk management – have non-compliance effects properly controlled, provided that arising from reasons proven to be related to the pandemic.

The exceptionalities, duly listed in the RDC, are divided into two categories: those of immediate implementation after notification to ANVISA and those of implementation upon ANVISA’s evaluation and favorable manifestation.

These exceptionalities can only be petitioned if the companies involved in the manufacturing process hold a valid Good Manufacturing Practices Certificate, issued by ANVISA.