Brazil- Anvisa


The guideline describes the minimum technical requirements to be presented by the companies for the temporary Authorization for Emergency Use of drugs for Covid-19.


Anvisa published last week the version 1 of Guide No. 49/2021, which deals with the request for temporary Authorization for Emergency Use (AUE) of drugs for Covid-19. The document contains the minimum technical requirements to be submitted by companies to apply for experimental AUE of drugs intended for the treatment of the disease, in accordance with the Resolution (RDC) 475/2021.

For the decision, Anvisa should consider the benefit-risk ratio of the drug, considering the data presented, the intended target population, the drug’s characteristics and the available scientific evidence, and the drug’s benefits should clearly and convincingly outweigh its risks.

Application Requirements

1 – Only companies that hold a registration in Brazil and that have a Company Operating Authorization (AFE) issued by Anvisa to manufacture or import medicines can apply for the AUE for drugs;

2 – The drug must have either a completed phase 3 clinical trial or interim analysis results from one or more phase 3 clinical trials that are ongoing;

3 – The company must commit to conclude the clinical development of the drug, present and discuss the results with Anvisa, and apply for sanitary registration in Brazil;

4 – Before the formal submission of the application for temporary authorization, the applicant shall schedule a pre-submission meeting with Anvisa to present:

  • the development of the drug product and its prospects for proof of quality, efficacy, and safety;
  • the world scenario of the drug product regarding the evaluation of good manufacturing practices, quality, efficacy, and safety by other regulatory authorities;
  • information on the production sites for each manufacturing stage of the active pharmaceutical ingredient and finished product; and
  • other pertinent information as to the characteristics of the product and of the company.


1 – Index;

2 – Description of the drug and its intended use;

3 – Justification for the request of the drug product’s AUE, considering the epidemiological, therapeutic, and public health context of the country;

4 – Description of the product’s regulatory status at ANVISA (whether the drug is registered or not); whether the drug or the intended use has a clinical research protocol at ANVISA;

5 – History of previous interactions with Anvisa;

6 – Description of the international approval status of the drug product;

7 – Risk assessment based on the data presented, demonstrating that the benefit-risk ratio of the emergency use of the drug is favorable;

8 – Quality information, for the active pharmaceutical ingredient (API) and the finished product;

9 – Information on the safety and effectiveness of the proposed drug product;

10 – List of the sites where the drug product is or will be manufactured, and the Good Manufacturing Practice (GMP) related documents of the manufacturing site(s):

  • Site Master File (SMP);
  • Inspection report issued by a PIC/S participating authority (Pharmaceutical Inspection Co-operation Scheme – PIC/s) or Good Manufacturing Practice certificate issued by Anvisa;
  • Process validation of the drug(s);
  • Valid Good Manufacturing Practices certificate issued by the sanitary authority in the country where the manufacturing establishment is located.

11 – Information on the forecast of the quantity of finished product available for importation or availability in the Brazilian market;

12 – Package insert and labeling;

13 – Risk management plan, describing routine Pharmacovigilance actions;

14 – Discussion of the known and potential risks and benefits of the drug product, including the measures to mitigate the risks and enhance the benefits; the limitations, uncertainties, and gaps in the data; description of the contraindications, if any.


Anvisa will evaluate the request for authorization for the emergency and temporary use of the Covid-19 drug, within 30 (thirty) days.


Applications for vaccine AUEs for COVID-19 should follow the guidance in the Guide No. 42/2020.

For more information, access the guide No. 49/2021 here (available only in Portuguese)

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