PXL/HO/Cir-047/2020-21                                                                             Date: 17.07.2020

Hyderabad

Dear Sir/Madam,

Subject: Inspection Procedures/ measures being followed by the Brazilian National Health Surveillance Agency (ANVISA) during COVID-19 pandemic

We are glad to share the inspection procedures and the measures adopted by the  Brazilian National Health Surveillance Agency (ANVISA) in the exceptional circumstances of Covid-19 pandemic.

1. ANVISA has adopted alternative certification procedures based on remote inspection or reliance on data from other health authorities, In this regard, The Resolution of the Collegiate Board (“Resolucao da Diretoria Colegiada” – RDC) of ANVISA No.346/2020 of Mar 13th establishes extraordinary and temporary criteria and procedures for the certification of Good Manufacturing Practices (GMP) for the purposes of registration and post-Registration of active pharmaceutical ingredients (API), drugs and health products. With regard to the certification related to medicines and pharmaceutical supplies, the resolution establishes the possibility of certification based on reports issued by member countries of the “Pharmaceutical Inspection Cooperation Scheme” (PIC/S), even in  cases where the company is not based in a country which is part of the scheme. For the certification of healthcare products, information from the “Medical Device Single Audit Program “(MDSAP) is accepted. For certifications related to pharmaceutical inputs, the resolution allows the acceptance of results from the “Program to rationalize international GMP inspections of active pharmaceutical ingredients / active substance manufacturers”.  In addition to these alternatives, the resolution also allowed certification based on remote audits carried out by ANVISA.
2. With regard to the possibility of acceptance  of studies  of safety,  efficacy  and quality  for the purposes  of drug  registration, ANVISA  has informed that the  RDC no 348/2020 of March 17th establishes special procedures for drug registration that

• Have specific therapeutic indication for the prevention or treatment of COVID-19,
• Can be useful in the clinical management of the disease or
• Contribute to lessen the burden on the national health system.

Such special procedures include flexibility of evidence and prioritization of analysis. With this RDC, post-registration changes to medicines that are necessary to maintain the national supply may follow simplified procedures.  For more details on the registrations and post-registrations approved by this resolution, ANVISA recommended consulting a document prepared by the General Management of Medicines and Biological Products (GGMED),  available at the following the following electronic address http://portal.anvisa.gov.br/documents/219201/4340788/Carta+GGMED.pdf/b315c8ec-0416-400b-b7e6-61414616b797

      3. With reference to the requirement for printed documentation to import goods into Brazil, the  Ministry  of  Economy  has  eased  the requirements  for the presentation  of certificates of origin during emergency situations, state of public calamity or a pandemic declared by the WHO, extending the deadline for the presentation of the certificate to 60 days after the import declaration is registered. The flexibility was determined by means of the Normative Instruction No. 1936, dated April 15th 2020.

Members may kindly make use of this important updates of ANVISA to continue their exports to Brazil seamlessly.

Best Regards

Udaya Bhaskar

Director General