Changes require attention from companies to maintain regulatory compliance and avoid penalties
In July 2024, the National Health Surveillance Agency (ANVISA) published an update on the criteria for registration and renewal of tobacco-derived smoking products, such as cigarettes, cigars, and cigarillos. The measure reinforces the need for attention on the part of companies in the sector, since failure to comply with the requirements may lead to the automatic cancellation of the sanitary registration.
QR Group, a company specializing in regulatory consulting for the health sector, details the main points of the update and guides how manufacturers can ensure compliance with ANVISA’s requirements.
What has changed in the regulation?
According to the new ANVISA publication, all smoking products must have active health registration and renewed within the legal deadlines. Failure to send a renewal petition implies the automatic expiration of the marketing authorization. In addition, trademark registrations and product presentations must be aligned with the provisions of RDC No. 14/2012.
The agency also stressed that products that do not comply with the requirements will not be able to remain on the market, being subject to penalties such as recall and administrative sanctions.
Impacts on the tobacco sector
The regulatory update has direct implications for companies operating with tobacco products in Brazil:
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Need for strict management of registration and renewal deadlines;
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Risk of interruption of sales and financial losses due to non-compliance;
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Stricter inspections by ANVISA;
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Continuous technical reassessment of regulatory dossiers and packaging.
The absence of a well-structured regulatory strategy can compromise the performance of companies in this highly regulated segment.
How QR Group can help your company
With solid experience in the regulatory sector and deep knowledge of ANVISA legislation, QR Group offers:
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Analysis of current compliance of records;
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Strategic planning for petitioning and renewal within the deadlines;
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Technical support in adapting to RDC No. 14/2012;
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Complete monitoring of processes with ANVISA.
QR Group’s performance is guided by technical excellence, agility and commitment to process safety, ensuring that its customers keep their products available in the market without regulatory risks.
Talk to QR Group
Does your company work with smoking products and need to ensure regulatory compliance with ANVISA?
Count on QR Group’s technical support to keep your records up to date and your operation safe.
Source: QR Group
