Under TPD, producers of devices are responsible for the quality and safety of their products. We are here to help and guide you through the process of ensuring your products comply with this legislation.
REQUEST A QUOTE & BOOK TESTING
At this first stage, we will send you a quotation. Once you have enlisted our services, we will email the following documents:
- lient application form
- Recipe workbook for any e-liquid component
- Device packing form
- Client information sheet
- Non-Disclosure Agreement (NDA) .
MAKE PAYMENT AND POST DEVICES
Secure your testing by making a 50% deposit if the order is over £3,001, or full payment if under £3,000. Next complete the recipe workbook, if applicable, which asks for the:
- Manufacturer’s name
- Flavour name
- Flavour code (this will be on the order form from your supplier)
- Percentage of concentrate
- Device questionnaire.
If you require any help or information about this, please contact the team on +44 (0)1302 986088. Once completed, email it to firstname.lastname@example.org.
Next, complete the Device packing form, place your devices into a polythene bag and post in a bubble/padded envelope to ADACT Medical Ltd, 3 Nelson Street, Doncaster, South Yorkshire, England, DN4 5AD, UK. Our Formulator will check each recipe to see if the formulations contain any banned ingredients. If they don’t, we will then carry out testing and analysis to establish if your products contain any of substances prohibited under TPD. If they do, we will advise you to re-formulate the recipe before sending new samples for testing.
OBTAIN A SUBMITTER ID
Apply for a Submitter ID from the EU-CEG portal (EU common entry gate), or we can do this on your behalf – this information is essential for any business filing for TPD submission. Alternatively, if your company is based outside the EU, we know exactly what documentation you will need to prove your business is a legal entity.
After testing, our experts will check the emissions data to ensure everything is as it should be. It is only then that we can proceed to the next stage.
FILING: PRESENTATION REPORT; FINAL PAYMENT DUE
We can help you set up a European Commission Authentication Service (ECAS) account. This will give you access to the Communication and Information Resource Centre for Administrations, Businesses and Citizens, which is the portal for uploading XML files.
Once we have compiled all your XML files, we will send you a Presentation report to check all the data is correct. After the report is approved, the remaining 50% of the invoice is due for payment (if it was over £3,001).
E-TRUSTEX AND EC:ID NUMBERS
We will then make your submissions to e-TrustEx, a secure platform for exchanging documents. We will also generate your European Community Identification Number (EC-ID) that is specific to your e-liquid. This is then listed on the MHRA website, which confirms the necessary standards have been met. The MHRA will then send you an invoice for their fees. If your product will be notified outside the UK, we will direct you towards the country-specific portal.
SELL YOUR DEVICES
Once your notification has been published on the MHRA website, you can launch your product in the UK.