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Vaping Industry Forum 2018



Tomorrow’s world: Next generation vaping innovations to watch out for


Clive Millington

Chief Executive, AYR


Headline Sponsor

Slide #3, part c

And we at AYR are at the forefront of that revolution.

Smokers told us…

Smokers told us…

Smokers told us…

Slide 12Waiting for Keeley

We’re lookingforward to working with you



Danny Sohota

Managing Director, Real Trading Ltd


Headline Sponsor


Real Trading – Who are we?


Vape Station Reinventing Vape Sales in Retail




John Dunne

Managing Director, E-Liquid Brands


Headline Sponsor



How do we encourage the millions of smokers who want to quit to choose

vaping?


How do we get the different sectors of the industry to work together?



Let the Q&A session begin...



Dr Ian Jones

Vice President of Reduced-Risk

Products, JTI

Germana Barba Vice President Regulatory Strategy & Engagement at Philip Morris International

Ben Wilson

Managing Director, BSMW Ltd

Duncan Cunningham Corporate & Legal Affairs UK & Ireland, Imperial Brands

John DunneManaging Director, E-Liquid Brands Henrik Brostrom

Head of External Engagement – Next

Generation Products - British American

Tobacco

Vaping Industry

Forum 2018

Panel Debate: The role of the tobacco and

pharmaceutical industries in the future of vaping

Chair: Gareth Johnson MP Parliamentary Private Secretary to the Secretary of State for Exiting the European Union


Headline Sponsor

Taking global leadership on standards


Craig Copland

E-Cigarette Unit Manager, MHRA


Headline Sponsor

MHRA UpdateUKVIA Forum 2018Craig Copland

53

MHRA responsibilities under the TPD

implemented by the TRPR 2016

• Operate UK notification system via EU-CEG

• Process and publish list of notified products

• Operate adverse reactions scheme

• Carry out vigilance tasks upon receiving reports of non compliant products in use

54

UK Notified products (31/3/18)

Active – 47642

• Incomplete submissions

• Current processing

• Informed of intention to withdraw

• Incorrect notification of intention to market in the UK

Inactive - 8092

• Withdrawn by producer

55

UK Published products (31/3/18)

• Total Products - 34937

• Devices - 3033

• Liquid/Refill containers - 31904

56

Vigilance

• Notifications

• Yellow Card

• Updated portal function

• Intelligence

• Partnership working

57

Notifications

• Missing toxicology reports

• Missing Emissions reports

• Six declarations often incorrectly completed

• Submitted sub brand information has caused issues at retail

• Please be sure to have notification check for completeness it will cause delay to your

publications

58

Yellow Card

40 E-cigarette adverse reaction reports

59

Yellow Card – findings

31 (77.5%) were reported by members of the public

9 (22.5%) were reported from healthcare professionals

109 symptoms recorded across the 40 reports

60

Yellow Card – findings

0 5 10 15 20 25 30

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

GASTROINTESTINAL DISORDERS

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

NERVOUS SYSTEM DISORDERS

SKIN AND SUBCUTANEOUS TISSUE DISORDERS

CARDIAC DISORDERS

INJURY, POISONING AND PROCEDURAL COMPLICATIONS

PRODUCT ISSUES

IMMUNE SYSTEM DISORDERS

EYE DISORDERS

INVESTIGATIONS

PREGNANCY, PUERPERIUM AND PERINATAL CONDITIONS

PSYCHIATRIC DISORDERS

VASCULAR DISORDERS

Number of reactions

Graph 1 - Number of reactions associated with e-cigarettes, reported via the Yellow Card Scheme, broken down by MedDRA System Organ Class

61

Updates to EU-CEG

On-going updates to portal functionality are making it easier to review notifications

for compliance of:

• Ingredients

• Tank capacity

• Refill container size and concentration

62

Intelligence

• Intelligence reports are being provided by industry

• A wider Industry commitment to higher standards and vigilance

• A desire to see a level playing field

• Support for enforcement of the regulations

63

Funded partnership working

• DHSC funded retail compliance project

• 90 MHRA compliance interventions as a result of Trading Standards referrals.

• Report from CTSI/DHSC due later this year

64

Funded partnership working

• MHRA funded product testing with CTSI

• Testing of products from the online marketplace for TRPR compliance

• Report from CTSI due later this year

65

Partnership working

• Continue to work with industry via trade bodies to improve compliance and best

practice

• Provide feedback and ongoing advice with regular news letters

• Continue to provide support for local authority enforcement

• Promote closer working relationships between industry and Trading Standards

66

Partnership working

• EU Joint Action Tobacco Control group and EU Expert Panel

• Department of Health

• Public Health England

67



Dr Sudhanshu Patwardhan

Senior International Engagement Manager, BAT


Headline Sponsor


Outline

• What are standards?

• Why do we need them?

• Vapour products: From BSI to international standards


What are standards?

“Documents that provide requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products,

processes and services are fit for their purpose” ISO

The standard simply provides a shorthand way of claiming that certain specifications are met, while encouraging manufacturers to adhere to a common method for such a specification.

Vaping Industry Forum 2018Standards vs. Regulations

Standards Regulations

However, standards can be incorporated into or help implementation of regulations

Industry led Mandated


Rationale for E-cig standards development

Key Drivers

1. Need to assure regulators and consumers alike on the quality and safety of e-cigs, amidst growing concerns due to alarmist media reporting

2. Ensuring that a uniform harmonised approach to product quality and safety is followed globally

3. Create standards that underpin regulations (in EU) and provide a template for regulations (outside the EU)

Vs.


E-LIQUID SAFETY

SAFEST INGREDIENTS

RIGOROUS TESTING

HIGHEST STANDARDS

DEVICE SAFETY

QUALITY MATERIALS

THOROUGH VAPOR ANALYSIS

DEVICE CERTIFICATION

PRODUCT PERFORMANCE

VAPOR EMISSION TESTING

Stewardship stretches from ingredient selection to vapour

*Stewardship of e-cigarette flavours, S. Costigan and C. Meredith, Regul Toxicol Pharmacol . 72: 361–369, 2015

Industry product assessment builds consumer confidence in product quality and safety

Vaping Industry Forum 2018The BSI Publicly Available Specification is the closest to a ‘standard’ for e-cigs…

AREAS EXAMPLES IN BSI PAS

Process and quality control traceability in supply chain

Purity of e-liquid ingredients in manufacture pharma grade nicotine

Contaminants arising from device materials and potential emissions from device operation

shelf life studies

Electrical safety Complying with existing directives

Metals and carbonyls in emissions toxicological risk assessment


More is needed at the Global level

• What will the new standards look like?

• When can we expect them?

• What will they provide?

Vaping Industry Forum 2018Current e-cig projects @ CEN and ISO

Regional International

Example CEN (European) ISO

Time to come up with specification/standard

3-5 years 3-5 years

Current commitment on e-cigs

CEN TC 437 initiated in 2015 ISO TC126 (the tobacco committee) has initiated a specific e-cigarette “sub committee”- SC3

Current work on e-cigs Four working groups:WG1: Terms and definitionsWG2: DevicesWG3: e-liquidsWG4: emissions

Work items already started:WG1: Measuring nicotine, PG and VG in e-liquidsWG2: Vaping regime (expected by end of 2018)


Overview: global vapour product standards

77

Liaising with CEN and CORESTA to introduce first technical standards on e-

cigarettes in 2018

More than 13 European National Standards Bodies

working with vapers, regulators, industry and

public health

British and French standards created by multi-

stakeholder groups

A key decision at COP7 in New Delhi (Nov 2016) : “WHO to report on the development of methods by regional and international standards-

development organizations for the testing and measuring of contents and emissions of these products”.


Thank you for listening

Dr Sudhanshu PatwardhanSenior International Engagement

Manager, BAT

Dr Lynne Dawkins

Associate Professor of Psychology, London South Bank University

Sarah Jakes

Chair, New Nicotine Alliance

Gerry Stimson

Emeritus Professor, Imperial College

Panel Debate: Bolstering public health

evidence – just what the Dr prescribed

Chair: Rt Hon Norman Lamb MP

Chair of the Science and Technology

Select Committee


Dan Marchant

Chief Executive, Vape Club


Drinks reception



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