Article 19 of the European Union Tobacco Products Directive (the "TPD") sets forth notification requirements for the commercialization of novel tobacco products in the Member States. Specifically, Article 19 states that manufacturers and importers must submit a notification to the Member States' competent authorities of any novel tobacco product they intend to place on the national market concerned.
The notification must be submitted electronically and at least six months prior to the intended date for placing the product on the market. Such notification must include a detailed description of the novel tobacco product and instructions for its use. Additionally, specific information regarding ingredients and emissions must be included as detailed in Article 5 of the TPD.
Moreover, notification submissions for novel tobacco products must provide competent authorities with the following information:
- (a) available scientific studies on toxicity, addictiveness and attractiveness of the product, in particular as regards its ingredients and emissions;
- (b) available studies, executive summaries thereof, and market research on the preferences of various consumer groups, which includes young people and current smokers;
- (c) other available and relevant information, including a risk/benefit analysis of the product, its expected effects on initiation and cessation of tobacco consumption, and predicted consumer perception.
Manufacturers and importers shall submit to Member States’ competent authorities any new or updated information referred to in points (a) to (c) above. Member States may require manufacturers or importers to carry out additional tests or submit additional information.
The Scientific Dossier and its appendices summarize the above based on PMI’s scientific assessment program and include the results of the assessment program for Platform 1 as of May 2016.
Download the Appendices:
EHTP Redacted Technical and Scientific Dossier, version 3.2, released 29 October 2019
Download its Appendices:
Appendix 1 - Expert Report of Prof Dr Valerio Cozzani
Appendix 2 - Expert Report of Prof Dr Rolf Bass on Risk Benefit Assessment
Appendix 3 - Tobacco Heating Devices
Appendix 4 - EHTP Manufacturers
Appendix 5 - PMI List of Analytes and Constituents
Appendix 6 - Indoor Air Quality
Appendix 7 - Pre-clinical assessment summary
Appendix 8 - ZRHR-PK-01-EU Clinical Study Summary
Appendix 9 - ZRHR-PK-02-JP Clinical Study Summary
Appendix 10 - ZRHM-PK-05-JP Clinical Study Summary
Appendix 11 - ZRHM-PK-06-US Clinical Study Summary
Appendix 12 - Biomarkers of Exposure Selection and Justification
Appendix 13 - ZRHR-REXC-03-EU Clinical Study Summary
Appendix 14 - ZRHR-REXC-04-JP Clinical Study Summary
Appendix 15 - ZRHM-REXA-07-JP Clinical Study Summary
Appendix 16 - ZRHM-REXA-08-US Clinical Study Summary
Appendix 17 - ZRHR_ERS_09_US Study Protocol
Appendix 19 - THS-PBA-02-US Study Summary
Appendix 20 - THS-PBA-03-US Study Summary
Appendix 21 - THS-PBA-04-US Study Summary
Appendix 22 - THS-PBA-05-RRC-US Study Summary
Appendix 23 - THS-PBA-05-RRC2-US Study Summary
Appendix 24 - THS-PBA-05-REC-US Study Summary
Appendix 25 - THS-PBA-06-US Study Summary
Appendix 26 - THS-PBA-07-US Study Summary