Mandatory under Directive 2014/40/EU TPD-II [Art. 20 (2)].

The notification process is conducted thanks to a mix of scientific, regulatory and IT competencies in accordance with EU Implementation Decision 2015/2183 of 24 November 2015.

You can count on a dedicated personal assistant, who coordinates the whole process and become a unique and qualified referent for each request from and to Member States.
All the documents concerning your notification process (analysis results, xml files, receipts, etc..) will be stored in a very safe dedicated section of our IT systems, shared with you to have your files always available.

The complete procedure customizable according to your needs, includes:

• Getting the Submitter ID;
• Analysis of emissions and consistency of nicotine release;
• Entering of analysis results (analysis of emissions and consistency of nicotine dose);
• Assessment of compliance with TPD-II requirements; possible development of a specific proposal to reach compliance in case of any lack;
• Inclusion of the CLP classification of the mixture (we can also supply you with the assessment of the accuracy of the given classification, considering the complete formulation of the product and with the correction);
• Assembling of the notification with data about: manufacturer and person responsible for the products, target markets, emissions and consistency of nicotine dose, product characteristics, declarations of conformity, description of the production process, quali-quantitative formula, weights and volumes, …;
• For each ingredient of the formulation, entering of: name and identification code, toxicological status, REACH position, CLP classification, assessment through toxicological reports made by our scientific team coordinated by a toxicologist with RENTIC (National Register of Certified Italian Toxicologists) and ERT ( The European Register of Toxicologists) qualifications;
• Production of the xml file and validation using the European Commission software according to the latest provisions from the dedicated team at the EU (SANTE team);
• Delivery of the files (submitters, attachments and submissions xml) to Member States through the EU Common Entry Gateway (EU-CEG) of the European Commission;
• Direct notification follow-up with the dedicated office at the European Commission and with officials of each Member State of destination. Assistance on any revisions and required queries;
• Sending of the notification receipt produced by EU-CEG;
• Issue and delivery to the customer of a declaration of notification;
• Checking of ‘transition period’ and messages of ‘alert’ to schedule the selling of product;
• Mediation and assistance in the event of a dispute or requests from the authorities;
• Periodic updates of notifications according to the modalities defined by each Member States.

General Conditions of Sale