[vc_row][vc_column][vc_column_text]
Do you wish grow your vape business in the UK and other EU member states? We can help. In May 2016 new rules came into force which means vape products must be notified to the authorities before they can be sold. We can assist your company to prepare and submit the required product notifications with our TPD Notification Service.
The TPD requirements include:
Read more about the notification and costs
We can help prepare and submit all that is required for the notification, including:
There maybe minor additional tasks once the notification is submitted such as responding to agency requests for information. We will provide support to ensure the notification is successful and help you answer any agency questions you receive.
Once submission has been made we provide you with the following:
Please contact us for pricing enquiries. For agency fees please click here.
Talk to a TPD expert today to learn more about the regulations and get a quote.
[/vc_column_text][vc_empty_space][/vc_column][/vc_row][vc_row][vc_column][vc_column_text]
Have you submitted your notifications but not received invoices from the agencies? Are you waiting prolonged periods to get your products to appear on the UK’s MHRA website?
We can help to resolve compliance issues like these. We offer impartial, expert advice to help retailers, importers and manufacturers overcome compliance issues relating to notifications, labelling and other regulatory matters.
The new e-cigarette regulations mean only notified products can be sold on the market. Manufacturers must submit product information to agencies in a notification. Submitted information is reviewed for compliance and, if compliant, the product gets uploaded to a ‘notified products’ list. Only once the product is on the list can it be sold.
Preparing and submitting the notification is a complicated and technical process. It requires a thorough understanding of the technical and procedural requirements. If it is not prepared or submitted correctly – and it only takes a very minor error to cause a problem – then the notification can fail.
Of course, if the notification fails then product will not be listed on the agencies website and the submitter cannot market the product. So if there are any delays caused by problems with the notification then it is crucial to resolve the problem swiftly and get the notification process back on track.
New requirements apply to the packaging and labelling of e-cigarette products. Among the requirements, a health warning statement should appear on the pack and certain information should appear in the leaflet.
Given the legal text can be vague in some areas, it is not surprising that manufacturers and retailers/importers are sometimes unsure of how to design the pack in a way that is TPD compliant. The issue is further complicated by the fact that country-specific requirements apply – so packaging and labelling differs market to market.
The authorities offer some useful support to help resolve compliance issues. But often it can take a long time for them to get back to you (2-4 weeks) and sometimes it turns out – after many email exchanges – they can’t help after all.
Notifications: With our knowledge and experience in the preparation and submission of notifications, we can provide an insight into the requirements and procedures. We can throw light on what could have gone wrong and offer a number of options to help resolve the issue.
Packaging and Labelling: We can help bring clarity to the requirements and provide sound advice to help resolve packaging and labelling issues. Should there be the need for a change to the packaging, we can advise on a strategy to implement any changes in a way that causes minimal impact on sales. We specialise in providing manufacturers with country-specific pack and label requirements to help them comply with the differing regulations across Europe.
Response time: Given the prolonged period the authorities can sometimes take to respond in addressing notification or other compliance matters – particularly to highly complex ones – our aim is to significantly reduce the time taken to resolve issues so retailers/manufacturers can get back to business as usual.
Notification:
Packaging and Labelling:
* IT technical support is limited.[/vc_column_text][vc_empty_space][/vc_column][/vc_row]
We are a London-based regulatory affairs consultancy providing services to the e-cigarette, cosmetic, biocide, pharmaceutical and medical device industry. We help e-cigarette companies comply with the Tobacco Products Directive and pharmaceutical companies obtain and maintain medical product licences. We also offer UKAS accredited biocide and analytical testing services.