Article 19 of the European Union Tobacco Products Directive requires manufacturers to provide substantial information regarding novel tobacco products before placing them on the market.

PMI has therefore submitted a Scientific Dossier to the regulatory authorities of a number of EU Member States about Platform 1, available for download here in redacted form.

The required information includes a description of the product and its intended use, as well as available data regarding toxicity, addictiveness, attractiveness and consumer preferences. The Scientific Dossier and its appendices summarize the above based on the PMI’s scientific assessment program and include the results of the assessment program for Platform 1 as of May 2016.

 

Download the Dossier:

EHTP Redacted Technical and Scientific Dossier, version 3.0, released 25 May 2018

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 Device

Appendix 4 - EHTP Manufacturers

Appendix 5 - PMI List of Analytes and Constituents

Appendix 6 - Indoor Air Quality

Appendix 7 - Non-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 18 - THS-PBA-01-US

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

Appendix 27 - Summary and Analysis of WOT Data

Appendix 28_Panel of Owners in EU

Appendix 29 SUR v 1.1 09.05.2018