TPD Regulations: What are they?

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What are the TPD Regulations?

 

New rules on the sale and manufacture of vape products came into effect in May 2016. The TPD regulations include:

 

General TPD Rules

 

Rules on Product Characteristics:

  • Max. 2ml tank size
  • Max. 20mg/ml (2%) nicotine concentration
  • Child-resistance features
  • Tamper evidence packaging

 

Notification Requirements

 

Manufacturers and producers are required to submit a notification to the authorities for any products they intend to market. The required information includes:

Administrative: details such as the contact details of the producer, description of product and declarations on production conformity.

Scientific data: including the classification of each ingredient according to CLP Regulation EC 1272/2008, all known toxicological studies and emissions testing data (TPD Test).

Sales information: the volume of sales, preference of consumer groups and mode of sales is to be reported.

 


To what extent has the UK transposed the TPD regulations? Click here


Responsible Person

 

A company representative who is based in the EU should be identified in the notification. They will be the contact for the authorities or customers.

Advertising Restrictions

 

The following are prohibited:

  • TV advertising and sponsorship
  • TV product placement
  • Radio advertising and sponsorship
  • On-demand television advertising, sponsorship and product placement
  • Newspapers, magazines and periodicals – except trade publications and third country publications,
  • Internet display advertising, email and text message advertising – except trade publications and third country publications

 


Read more about TPD Requirements here


 

How can Medic Pro help?

 

We offer a wide range of services to help companies prepare for the TPD regulations, including:

 

In the absence of guidance…

 

With e-cigarette regulation still in development, there are few official guidelines and no official standards. Where guidance is lacking, pharmaceutical regulatory guidelines can be used as a model. This is because e-cigarette regulation is based upon pharmaceutical regulations. Our knowledge and experience in pharmaceutical regulatory affairs combined with knowledge on the latest developments in e-cigarette regulation allows us to help manufacturers prepare early.

“Medic Pro really helped to alleviate the pressure caused by the TPD. We import products from China and getting the necessary assurances [as a result of the TPD] was sometimes difficult. Medic Pro supported us to make sure we were meeting our commitments. They also gave us confidence that whatever compliance issue might arise – with their support – it could be dealt with.

We’re very satisfied with the service and more than happy to recommend them.”

Fred (UK importer/retailer)