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Gap Analysis
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Review your current product dossiers and submissions filed to date in the EU and US (Premarket Tobacco Product Applications - PMTA or substantial equivalence – SE, ingredient reports, facility registration) to ensure compliance and assess resources required to maintain compliance over the next period of time. Review product development, sales and marketing activities proposed in a given jurisdiction to ensure risk minimization. Thorough overall business assessments to identify potential regulatory risks and ensure that all aspects of the business are compliant with vaping laws across European markets.
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Compliance Education and Prevention
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Provide remote and in person compliance trainings regarding product and marketing compliance to senior management and selected departments in the company, such as: nicotine regulation, stakeholders positions on nicotine, marketing freedoms, building a responsible company etc.
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EU Premarket Notification (by product)
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Under the Tobacco Products Directive (2014/40/EU), manufacturers and importers of electronic cigarettes and refill containers, as well as conventional cigarette products (with heated tobacco products being classified as cigarettes in certain jurisdictions) have to submit key information of their product to the authorities in the Member States in which they plan to market the products. The registration process is made through the EU Common Entry Gate (EU-CEG) platform. The process is mandatory and must be done 6 months before their intent of launching the product into the national market. Please note that our turnaround time starts with the receipt of all necessary information from client to compile the notification.
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Compliance Reports & Advice
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Thorough assessments to identify potential regulatory risks and ensure that all aspects of the business are compliant with vaping laws across European markets.
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Packaging Review & Design
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Our experts review and ensure that packaging meets all regulatory requirements, including health warnings, labeling, and design standards, to ensure market readiness and compliance. We also have a team that designs compliant labels and packaging for companies that come under the Tobacco Products Directive (2014/40/EU).