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# In the tabs at the top select [http://ec.europa.eu/health/euceg/download_en ‘Downloads’] | # In the tabs at the top select [http://ec.europa.eu/health/euceg/download_en ‘Downloads’] | ||
# | # | ||
# Click the link that says ‘[https://circabc.europa.eu/w/browse/7dedde5d-b276-40f6-8d21-ccf98df87d46 e-cigarettes and refills]’. You will need an ECAS account to access this page. If you cannot see the information below, you will need to create an ECAS account, log in, and start again from step 2 | # Click the link that says ‘[https://circabc.europa.eu/w/browse/7dedde5d-b276-40f6-8d21-ccf98df87d46 e-cigarettes and refills]’. You will need an ECAS account to access this page. If you cannot see the information below, you will need to [https://webgate.ec.europa.eu/cas/wayf?loginRequestId=ECAS_LR-21723079-0mO1Gig6at8PBf8vSY2n1oUJnf9HYLhbvkVyoNvTlnkB69ivYg1Hkn5TyrId4tYYPoG88doLTVcvrZvaoynNpm-Jj71zxYb8yrdaMmFt4gSYi-5dNULQGlUEnYvmsXlu1gzzL38AUrzukRKdfOsoNiHSgy&caller=%2Fcas%2Flogin create an ECAS account], log in, and start again from step 2 | ||
# | # | ||
# You have now accessed the CIRCABC (Communication and Information Resource Centre for Administrations, Businesses and Citizens). Click ‘latest version of technical documents’ | # You have now accessed the CIRCABC (Communication and Information Resource Centre for Administrations, Businesses and Citizens). Click ‘latest version of technical documents’ | ||
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# On this page you will find: | # On this page you will find: | ||
The ETRUSTEX tutorial.pdf, which contains all the necessary information regarding how to: | *The ETRUSTEX tutorial.pdf, which contains all the necessary information regarding how to: | ||
submit your XML through the web interface; | submit your XML through the web interface; | ||
read the encrypted messages sent by EU-CEG; and | *read the encrypted messages sent by EU-CEG; and | ||
manage user accounts in the XML upload system (E-trustex) | *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) | *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) | *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-1.1.3.zip) | *The XML creator system (tpd-xml-creator-tool-1.1.3.zip) | ||
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-1.1.3.zip and run the file named the tpd-xml-creator-tool-1.1.3.jar | *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-1.1.3.zip and run the file named the tpd-xml-creator-tool-1.1.3.jar | ||
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. | *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 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 portal’s technical team directly via the email addresses below: | *Please note 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 portal’s technical team directly via the email addresses below: | ||
=EU-CEG Contacts= | |||
Should you encounter technical difficulties, please contact SANTE-EUCEG-ITSUPPORT@ec.europa.eu (including in your message a ‘print screen’ of the window where the problem appears) | Should you encounter technical difficulties, please contact SANTE-EUCEG-ITSUPPORT@ec.europa.eu (including in your message a ‘print screen’ of the window where the problem appears) | ||
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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. | 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. | ||
Guidance on the content of notifications | =Guidance on the content of notifications= | ||
The format and content of notifications are set out in the [http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32015D2183 Commission Implementing Decision] (EU) 2015/2183 on e-cigarettes. | |||
Technical requirements for refill mechanisms, and information that must be included in the instructions for use of the product are set out in the Commission Implementing Decision (EU) 2016/586 of 14 April 2016 on technical standards for the refill mechanism of electronic cigarettes. | Details of the information notifications are required to contain are set out by the Commission in the [https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/615094/TPD_submission_data_dictionary_electronic_cigarettes_1.1.1__002_.pdf Data Dictionary] (PDF, 888KB, 37 pages). | ||
Technical requirements for refill mechanisms, and information that must be included in the instructions for use of the product are set out in the [http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2016.101.01.0015.01.ENG&toc=OJ:L:2016:101:TOC Commission Implementing Decision (EU) 2016/586] of 14 April 2016 on technical standards for the refill mechanism of electronic cigarettes. | |||
We have published below guidance to aid producers of e-cigarettes and refill containers to prepare notifications for their products. This guidance has been developed by the UK and other member states and discussed at the European Commission Working Group on notification of e-cigarettes and refill containers. | We have published below guidance to aid producers of e-cigarettes and refill containers to prepare notifications for their products. This guidance has been developed by the UK and other member states and discussed at the European Commission Working Group on notification of e-cigarettes and refill containers. | ||
Product type guidance (PDF, 168KB, 3 pages) | [https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/544092/2_Product_type_disc_paper_final.pdf Product type guidance] (PDF, 168KB, 3 pages) | ||
Submission type guidance (PDF, 412KB, 3 pages) | [https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/544091/1_Submission_type_disc_paper_final.pdfSubmission%20type%20guidance Submission type guidance] (PDF, 412KB, 3 pages) | ||
Emissions testing guidance (PDF, 93.9KB, 3 pages) | [https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/544094/3_Emissions_disc_paper_final.pdf Emissions testing guidance] (PDF, 93.9KB, 3 pages) | ||
Nicotine dose guidance (PDF, 74.2KB, 2 pages) | [https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/544095/4_Nicotine_Dose_disc_paper_final.pdf Nicotine dose guidance] (PDF, 74.2KB, 2 pages) | ||
UK ingredient guidance (PDF, 265KB, 3 pages) | [https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/682739/Ingredient_guidance_final_draft_011116.pdf UK ingredient guidance] (PDF, 265KB, 3 pages) | ||
Labelling guidance (PDF, 85.2KB, 2 pages) | [https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/520559/Labeling_Guidance.pdf Labelling guidance] (PDF, 85.2KB, 2 pages) | ||
UK product presentation guidance (PDF, 41.2KB, 4 pages) | [https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/561810/Presentation-Guidance__1_.pdf UK product presentation guidance] (PDF, 41.2KB, 4 pages) | ||
Annual reporting guidance (PDF, 35.9KB, 3 pages) | [https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/609686/Annual_reporting_guidance_Apr_17.pdf Annual reporting guidance] (PDF, 35.9KB, 3 pages) | ||
General advice on vigilance (PDF, 44.5KB, 2 pages) | [https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/771488/GENERAL_ADVICE_ON_VIGILANCE.pdf General advice on vigilance] (PDF, 44.5KB, 2 pages) | ||
General advice on due diligence (PDF, 42.5KB, 2 pages) | [https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/771489/GENERAL_ADVICE_ON_DUE_DILIGENCE.pdf General advice on due diligence] (PDF, 42.5KB, 2 pages) | ||
If you make your product available in the UK under several brand names, you will be able to include all the brand names for the identical products in a single notification, for no additional fee. Each brand should be listed on the notification as a separate presentation. | If you make your product available in the UK under several brand names, you will be able to include all the brand names for the identical products in a single notification, for no additional fee. Each brand should be listed on the notification as a separate presentation. | ||
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The TPD does not include any requirements as to where testing of e-cigarettes and refill container has to take place. The notifier will need to be satisfied as to the standards of any testing carried out as they have to submit a declaration that they bear full responsibility for the quality and safety of the product when placed on the market and used under normal or reasonably foreseeable conditions. | The TPD does not include any requirements as to where testing of e-cigarettes and refill container has to take place. The notifier will need to be satisfied as to the standards of any testing carried out as they have to submit a declaration that they bear full responsibility for the quality and safety of the product when placed on the market and used under normal or reasonably foreseeable conditions. | ||
Fees | =Fees= | ||
The fees for submitting a notification are a set out in The Electronic Cigarettes etc. (Fees) Regulations 2016. MHRA consulted on the level of these fees in January 2016 and the Government Response to the consultation can be found here. | The fees for submitting a notification are a set out in The Electronic Cigarettes etc. (Fees) Regulations 2016. MHRA consulted on the level of these fees in January 2016 and the Government Response to the consultation can be found here. | ||
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MHRA has given a commitment to review the level of fees in the light of the number of notifications received in the first year. | MHRA has given a commitment to review the level of fees in the light of the number of notifications received in the first year. | ||
Invoices | =Invoices= | ||
MHRA will send an invoice to each company for the notification fees due in relation to all products for which information has been submitted via the EU-CEG. Payment of this invoice is due immediately upon receipt. | MHRA will send an invoice to each company for the notification fees due in relation to all products for which information has been submitted via the EU-CEG. Payment of this invoice is due immediately upon receipt. | ||
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Swift Code NWBKGB2L | Swift Code NWBKGB2L | ||
IBAN GB68NWBK60708010004386 | IBAN GB68NWBK60708010004386 | ||
=Further information= | |||
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