Country-Specific Information

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What are country-specific requirements?

 

The Tobacco Product Directive harmonises the rules for tobacco and related products across the EU. There is little scope for the Member States to deviate from its provisions but there are some areas of flexibility. It is in these areas Member States are developing their own country-specific requirements.

 

Why are country-specific requirements significant?

 

Country-specific requirements represent an added layer of complexity to e-cigarette regulation in Europe.  Despite the harmonising efforts of the TPD, we will see the regulatory environment across Europe become more diverse.  In other words, a regulation that applies in one market, may not apply in another.

 

The areas where the Member State can decide their own regulations include:

  • Cross-border sales: Should the sale of products to another Member State be permitted (and vice versa)?
  • Transition period: How long should producers be given to sell through non-compliant stock?
  • Packaging and labelling: Which of the two health warnings should be used on the label?
  • Notification fee: How much should a Member State charge for a notification?

 

Transition period

 

Knowledge of the transition – or sell through – period of non-compliant stock in a market will be crucial in mitigating the risk of stock wastage.  For example. non-compliant stock may be allowed on a given market until May 2017 but in an adjacent market it may be Nov 2016.

Clearly, knowledge of sell through dates is key for companies with a presence in multiple EU markets.

 

How can we help

 

As part of our service to our clients, we provide country-specific regulatory information.  If you wish to learn more about local regulations in a particular market, please contact us.

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We are a European regulatory consultancy. We advise e-cigarette companies on the emerging regulations and help pharmaceutical companies obtain and maintain medical product licences.