Experiencing TPD compliance issues?
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.
TPD Notification issues
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.
Packaging and Labelling Issues
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.
Help from authorities can take time
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.
How can we help?
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.
Types of TPD compliance issues we can help resolve
- products not uploaded to agency’s notified product lists
- agency notification invoices not received
- conflicting information regarding product notification status
- technical issues with standalone notification software*
Packaging and Labelling:
- Health warning statement (or specification) incorrect
- information that does not need appear on the leaflet/label
* IT technical support is limited.