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.