ANVISA publishes the new regulatory framework for low-risk drugs subject to notification

On November 10, the National Health Inspection Agency (ANVISA) passed Rule RDC No. 576/2021 and Instruction No. 106/2021. These rules establish the new regulatory framework for low-risk drugs subject to notification (that is, drugs that are not subject to registration) and provides a new and extended low-risk drugs list. We highlight the main updates:

• New validity period for notifications: Previously, the validity period for notifications was 5 years. Now, the notifications will have a 10-year validity period, from the notification activation date.

• Qualification requirements for companies in the notification system: The manufacturing company must have a Good Manufacturing Practices and Drug Control Certificate (GMP) and the importing company must have a Good Distribution and Storage Practices Certificate (GDSP).

• Documents required for the notification process: Manufacturers or importers must submit the following documents: (i) descriptive production report; (ii) production orders and quality control reports for raw materials, packaging and finished product for each manufactured batch; (iii) quality control report; (iv) stability studies; and (v) model package leaflet, if any, and labeling.

New drugs included in the list: the new list now contains a total of 118 products. 39 new drugs were included (for example: acetaminophen/paracetamol and ketoconazole, among others). In addition, there were some changes in indications, dosages and concentrations of some drugs.

• Drugs excluded from the list: 10 products were excluded from the list because they were cosmetics or health products – not drugs. For example: cocoa butter, almond oil, talc and petroleum jelly.

• Post-notification changes: The company holding the notification must carry out (i) a risk analysis; and (ii) obtain a new notification whenever there are changes in any information provided. The old notification must be cancelled.

• Adaptation period: The drugs that were included or excluded from the list will have a 2-year period, counted from December 1, 2021, to adapt to the new rules.

• Deadline for label change: Companies holding notified low-risk drugs whose labeling is subject to change will have 365 days to make the necessary changes.

• Revoked previous regulations: RDC 576/2021 revoked the main legislations on the subject, including: (i) Rule RDC No. 107, of September 5, 2016; and (ii) Rule RDC No. 199, of October 26, 2006.

Please do not hesitate to contact our Life Science Team if you need any further clarification on this matter.