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Compliance as a Consumer Product

Are you ready to face the challenges imposed by the revised Directive? 

If you are an e liquid/e juice; retailer, wholesaler, manufacturer or importer you urgently to consider compliance with this Directive (2014/40/EU)
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32014L0040

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CambReg can give you a check list of what you need to do to comply and help you set a budget.

We are an experienced regulatory consultancy that has served the pharmaceutical industry for 17 years, helping them to reach their commercial goals on time and on budget.

How will the TPD affect your business?

Restrictions – potentially having a negative effect on the business: 

  • E liquid can’t contain more than 20mg/ml of nicotine
  • Cartridge/tank can’t be larger than 2ml.
  • E liquid refill can’t exceed 10 ml volume 
  • Promotion is prohibited
  • Member States may prohibit cross-border distance sales to consumers.
  • Requirements – some potentially very costly:
  • ‘Notifications’ need to be made to the Health Authority in each country you want to market your products in - see below for more detail. 
  • Packaging and Labelling – specific requirements 
  • Monitoring of the product’s Safety 


These restrictions and requirements are going to bring about major changes to how you operate your business.

Generating the data to put in to your Notifications will be the most costly part of compliance. Notifications need to ready to submit by 20 November 2016

What needs to be done?


1. Review your product list – only take forward your best sellers in the first instance

2. Let CambReg advise on the data that need to be generated for your Notifications
The most important are:

  • Emissions testing data 
  • Toxicological data on ingredients and emissions when inhaled 
  • Information on doses and uptake
  • Description of components 
  • Description of production process 


3. Let CambReg estimate the cost of drafting your labels & leaflets and setting up your safety monitoring service

4. Appoint a Responsible Person (CambReg does provide this service)

5. Discuss a compliance programme with CambReg (timings and costs)

The two Notification items that are the biggest worry for the industry are:


Emissions Testing
 

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Testing is not only expensive but the numbers of labs that carry out this type of testing are few. We can advise where to get your testing done

Toxicology Risk Assessment
According to PAS 54115:2015 – BSI (the only ‘standard’ currently available in the UK that applies to E Cigarettes) a risk assessment of each ingredient present in the product needs to be carried out in addition to an overall risk assessment of the whole product. Each of these reports can cost up to £5,000 to produce. If you choose to take 10 products forward with an average of 10 ingredients in each the cost of this exercise alone would be £0.5 million . At CambReg we are taking a novel approach to compliance in this area at least until adequate guidance on this topic is made available.

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Give us a call to discuss our low cost option – 01480 465755