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MHRA TPD Update Email 7: The European Common Entry Gate

Medicines and Healthcare Products Regulatory Agency

Hello from the MHRA e-cigarettes team.

The European Common Entry Gate (EU-CEG) is now open for companies who have obtained an EC-ID to submit notifications, and guidance has been provided on how to upload them to the portal. In this email, we help you find the guidance on the EU-CEG, and cover the end of the temporary submission process.

The EU-CEG portal

Until the 20th November 2016, as we outlined in our guidance on TPD transition periods, new products that enter the UK market should now be notified through the EU-CEG at least one day before they go on sale.

The European Commission have published some guidance to help you with the application process. You can find this guidance by following the steps below:

1) Ensure you have a EC-ID number

2) Go to the EU-CEG website (you will need to ensure your browsers are up to date. Google Chrome works best with this website)

3) Scroll down to the blue browse the theme table and click technical documents

4) At the bottom of the page, click the link that says For electronic cigarette and refill container stakeholders

5) You have now accessed the CIRCABC (Communication and Information Resource Centre for Administrations, Businesses and Citizens). Click latest version of technical documents (You will need an ECAS account to access this)

6) Unless you have an AS4 Access point, you will need to click XML Submission through web interface (if you do not know whether you have an AS4 Access point, or are not sure what one is, we recommend you use the web-interface option)

7) On this page you will find:

  • The ETRUSTEX tutorial.pdf, which contains all the necessary information regarding how to:
    • submit your XML through the web interface;
    • read the encrypted messages sent by EU-CEG; and
    • manage user accounts in the XML upload system (E-trustex)
  • A keystore (EUCEG_GUI_USER) to decrypt the messages received by the EUCEG system. (The ETRUSTEX tutorial gives you the information about how to use this keystore)
  • How to install the XML creator tool procedure (procedure to install the TDP XML creator tool.pdf)
  • The XML creator system (tpd-xml-creator-tool-1.1.1.zip)

8) Unless you wish to use a bespoke XML file creator, the Commission have provided one that is free for you to use. To access it, download the tpd-xml-creator-tool-1.1.1.zip and run the file named the tpd-xml-creator-tool-1.1.1.jar

9) Once you have created your XML files using the tool, you can upload them to the portal by following the instructions in ETRUSTEX tutorial.pdf.

Please note that MHRA does not run the notification portal or XML creator, and the steps above are for guidance only. If you have any difficulties, please contact the portals technical team directly via the email addresses below:

Contacts

  • Should you encounter technical difficulties, please contactSANTE-EUCEG-ITSUPPORT@ec.europa.eu (including in your message a 'print screen' of the window where the problem appears).
  • For other general matters related to the functioning of the EU-CEG, but not to your request, please contact SANTE-EU-CEG@ec.europa.eu

End of the temporary submission process

The temporary submission process we told you about in our last email was closed on the 8th June. Submissions will now only be accepted via the EU-CEG procedure, discussed above.

Those of you that started the temporary submission process must now complete the rest of your notification via the EU-CEG no later than 24 June 2016 at 18:00 CET (17:00 GMT). Failure to submit within this timeline will automatically render the provisionally assigned submission date obsolete. A full statement on the withdrawal of the temporary submission process can be found here.

Any other queries

If you have any technical enquires about the e-cigarettes notification scheme under Tobacco Products Directive, or the work of the MHRA, please send them to our official enquiries inbox: info@mhra.gsi.gov.uk.

Thank you for your time in reading and sharing this email with your contacts. We look forward to hearing from you.


Kind regards

Mark Wilcox

Campaigns Specalist

Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road, London SW1W 9SZ, UK
Telephone: 020 30806069

Email:mark.wilcox@mhra.gsi.gov.uk

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