The Resolution RDC No. 576/2021 and the Normative Instruction No. 106/2021 expanded the list of drugs that may have simplified registration. The notification process aims to simplify the regularization of low-risk drugs.
Brazil’s National Health Surveillance Agency (Anvisa) has approved the new regulatory framework for low-risk drugs subject to notification. These are drugs that do not depend on the Agency’s prior evaluation and registration process. For this group of drugs, it is sufficient that companies make a notification to Anvisa before starting their production and insertion in the market.
One of the main changes in the new rule is the expansion of the list of low-risk drugs subject to notification. In practice, it is an action to simplify for companies and reduce the burden of analysis of the Agency.
NEW LIST OF DRUG’S SIMPLIFIED REGISTRATION - Well Established Drugs
The new list brings 39 drugs that will simply be notified to Anvisa, with immediate start of production. Examples include paracetamol (pill) and ketoconazole (cream option), among others. This does not mean that these products will have reduced sanitary control. The list includes only well-established drugs, with a low probability of causing harm to humans and exempt from medical prescription.
The Resolution RDC No. 576/2021 and the Normative Instruction IN No. 106/2021, which will come into force on December 1st, 2021, will contemplate all the guidelines and requirements applicable to notified drugs. The Normative Instruction brings the List of Low Risk Drugs subject to Notification.
HOW IS THE NOTIFICATION PROCESS?
The notification aims to simplify the regularization of low-risk drugs, which do not undergo analysis prior to their commercialization, thus optimizing the regulatory process and access to quality medicines. Only well-established drugs, with low probability of causing harm to humans and exempt from medical prescription, can be subject to notification.
In this process, companies do not need to protocol the registration process for the drug and receive from Anvisa the authorization to manufacture and market the drugs through an electronic notification procedure, which is faster in releasing drugs to the market.
The notified drugs must meet all quality requirements and be produced in accordance with Good Manufacturing Practices. Interested companies must submit a notification for each drug on the list.
Anvisa assesses compliance with the health regulations in force by means of regulatory notification inspections of manufacturing companies.
The deadline for the migration of registered drugs to the notification process, as well as for the reclassification of those products excluded from the list, is two years from the effective date of the norm.
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