Tobacco Products Directive (TPD) Technical and Scientific Dossier

Scientific Dossier submitted to EU member state authorities in December 2016 following Article 19 of the European Union Tobacco Products Directive (TPD)


Authored by  PMI

Article 19 of the European Union Tobacco Products Directive (TPD) requires manufacturers to submit a notification to the competent Member State authorities for each Novel Tobacco Product six months before placing the product on the market in that Member State. Following the transposition of the TPD into national law, 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 PMI’s scientific assessment program and include the results of that assessment program for Platform 1 as of May 2016.

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

List of 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