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
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.
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
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.
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:
- TPD testing: we help source a cost-effective e-cigarette testing laboratory, while ensuring minimum testing requirements are met
- Notifications: we can prepare and submit notifications for e-cigarettes and e-liquids on your behalf.
- Toxicological assessment: we advise on the toxicological requirements and can provide a toxicology expert
- TPD compliance: we will review your product to check it is TPD compliant
- Manufacturing standards: we provide an insight into the manufacturing standards before they are published
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.