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. 2021 Dec 9:7:71.
doi: 10.18332/tpc/143331. eCollection 2021.

Reporting system of suspected adverse effects from electronic cigarettes and refill liquids in Europe

Renata Solimini  1 , Caitriona Stack  2 , Kathleen Clifford  2 , Laszlo Bencze  3 , Francisco M Ruiz Dominguez  4 , Constantine Ι Vardavas  5 , Panagiotis Behrakis  5   6   7
Affiliations

Reporting system of suspected adverse effects from electronic cigarettes and refill liquids in Europe

Renata Solimini et al. Tob Prev Cessat. .

Abstract

In line with Article 20 (9) of the Tobacco Products Directive (TPD) 2014/40/EU, a guidance document outlining a reporting system of suspected adverse effects from electronic cigarettes and their refill liquids was produced by Work Package 4 entitled 'Integration into national policies and sustainability' of the Joint Action on Tobacco Control (JATC). The JATC was a European project that lasted three years (2017-2020), with the general objective of providing support for the implementation of the TPD throughout the 27 European Union Member States (EU MS). The reporting system described in the guidance document includes a short reporting template for the reporting of adverse effects on human health from electronic cigarettes and refill liquids, both by Economic Operators (EO) and by National Competent Authorities (NCA). The present guidance document aims at providing the necessary steps and modalities that each MS should follow if involved in the development of a system for the reporting of suspected adverse effects on human health from electronic cigarettes and refill liquids.

Keywords: adverse effects; electronic cigarettes; reporting system.

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Conflict of interest statement

The authors have each completed and submitted an ICMJE Form for Disclosure of Potential Conflicts of Interest and none was reported.

Figures

Figure 1
Figure 1
Safety Cycle
Figure 2
Figure 2
Data processing flow
See this image and copyright information in PMC

References

    1. European Union Directive 2014/40/Eu of the European Parliament and of The Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing. Directive 2001/37/EC. Official Journal of the European Union. 2014 Accessed October 25, 2021. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32014L004... .
    1. Vardavas CI, Behrakis P, Tzortzi A, Kilibarda B. Ensuring sustainability and dissemination of TPD and JATC activities in Europe. Tob Induced Dis. 2018;16(3):12. doi: 10.18332/tid/95251. - DOI
    1. Vardavas CI, Girvalaki C, Odani S, et al. Profile of incidental exposures to e-cigarette liquids in Europe, 2018-2019. Hum Exp Toxicol. 2021;40(6):1045–1050. doi: 10.1177/0960327120975828. - DOI - PubMed
    1. Kyriakos CN, Filippidis FT, Hitchman S, et al. Characteristics and correlates of electronic cigarette product attributes and undesirable events during e-cigarette use in six countries of the EUREST-PLUS ITC Europe Surveys. Tob Induc Dis. 2018;16(Suppl 2):A1. doi: 10.18332/tid/93545. - DOI - PMC - PubMed
    1. Herrera A, Aravindakshan A, Jarmul S, et al. E-cigarette use behaviors and device characteristics of daily exclusive e-cigarette users in Maryland: Implications for product toxicity. Tob Induced Dis. 2020;18(November):93. doi: 10.18332/tid/128319. - DOI - PMC - PubMed

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