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