User reference guide – E-cigarettes Submissions

This is a step by step guide for users that wish to make submissions to notify E-
cigarette products in Great Britain via MHRA Submissions.

The system has been developed to allow a submitted notification to be used as a

base template for future notifications allowing notifiers to submit a range of products
swiftly and efficiently.

Section 1: How to make a Manual E-cigarette Submission

Section 2: How to make a Bulk E-cigarette Submission
Section 3: How to view previous submissions
Section 4: How to submit updates
Section 5: Tips & Troubleshooting on efficiently submitting notifications
Section 6: Frequently asked questions

To make an E-cigarettes-related submission, navigate to the ‘E-cigarettes’ tile of the

MHRA Submissions portal.

If a problem occurs whilst completing an E-cigarettes submission, please refer to the

frequently asked questions. If this fails to answer your question, please email
submissions@mhra.gov.uk
Section 1: How to make a Manual E-cigarette Submission
To begin making a manual E-cigarette submission, select ‘Submit’ from the E-
cigarettes tile homepage.

Step 1: Submission Type

Determine ‘Submission Type’ from the drop-down menu. Note: only one Type 1
submission is allowed for a submitter ID and product ID. This includes notifications
that are submitted or saved as draft.
Select Company from drop-down menu.
Enter ‘Submitter ID/Generate new Submitter ID/Submitter ID’ will be auto-populated
if previous submissions have been made.
Enter ‘Product ID (EC-ID)’ Format: Submitter ID-last two digits of the year (19)-five-
digit product number (XXXXXX-XX-XXXXX).
Enter any general submission comments.

Step 2: Submitter Info

Select the ‘Submitter Type’ from the drop-down menu.

If ‘Submitter SME’ or ‘Submitter has VAT’; tick the relevant tick box (and enter
submitter VAT).
Enter submitter details and tick whether ‘Submitter Has Parent Company’, ‘Has
Affiliate Company’, or ‘Submitter Appoints Enterer’ and provide subsequent details.
Then select ‘Save Submitter Details’.

After saving submitter details please proceed to the Product Details tab

Note: ‘Affiliate company’ is your UK-based responsible person/entity as required

under the regulations.
Step 3: Product Details

Select ‘Product Type’ from the drop-down menu and if an asterix appears alongside
‘Weight E-liquid’ and ‘Volume E-liquid’, fill in the fields.

‘Market Research’ or ‘Study Summaries’ can be uploaded if necessary. Then enter

the ‘CLP Classification’ if an asterisk appears.

Then include ‘Manufacturer Details’. Input ‘Manufacturer ID’ if required, then input
company, postal address, phone number, and email address.
Select ‘Add site’ and provide site details; site name, postal address, phone number
and email address and select ‘Save Site’. To remove a ‘Product site’, select the red
‘X’ on the right side of the screen.

Then select ‘Save product details’.

Step 4: Product Presentation

Under the ‘Product Presentation’ tab, select ‘Add’ to enter details.
Enter ‘Brand Name’.
Select ‘UK’ from the ‘National Market’ drop-down menu and provide any additional
comments. If any ‘Brand Subtype Name Exists’, please the tick the box and provide
the ‘Brand Subtype’ name.
Enter the e-cigarette launch date and withdrawal date (if indicated via ‘e-cigarette
withdrawal indication’).

Enter the ‘Product Submitter Number’, the ‘UPC Number’, the ‘EAN Number’, the
‘GTIN Number’, the ‘SKU Number’ and the ‘Package Units’ (where mandatory field is
indicated with an asterix).

Then provide any further details that are relevant to your submission.
Note: Type 6 applications will need to include annual sales data as required under
the regulations (please see ‘Annual Reporting Guidance’ via
https://www.gov.uk/guidance/e-cigarettes-regulations-for-consumer-products for
further information).

Then Select ‘Add Presentation’ before advancing. You can add further presentations
by repeating Step 4 again.

*Note: Remember to click Save Presentation Details after entering details for each
presentation added*

Please proceed to the Ingredients tab

Step 5: Ingredients

Under the ‘Ingredients’ tab, select ‘Add’, then enter the ‘Name’ and provide further
details relevant to your submission.
Tick the ‘CAS Exist’ box if appropriate and enter the ‘CAS’ details.
Select ‘Add Ingredient’ to confirm.

Details of all available toxicological studies on the ingredient in unheated and heated
form and emissions must be submitted. These supporting documents can be
uploaded via the below selectable fields.
If you wish to use the same information from a previously uploaded document, you
can refer to it using the ‘Refer Docs’ tab.

After selecting ‘Add Ingredient’, it will appear in the list as per below. Select ‘Save
Ingredient Details’ before advancing. You can add further ingredients by repeating
Step 5. An ‘Ingredient’ can be removed by selecting the red ‘X’.

Please proceed to the Emission tab

Step 6: Emission

Under the ‘Emission’ tab, select ‘Add’, then provide details for the mandatory fields
as seen below and upload ‘Method File’ by selecting ‘Upload’. If you wish to use the
same information from a previously uploaded document, you can refer to it using the
‘Refer Docs’ tab. Please see ‘Emissions Testing Guidance’ via
https://www.gov.uk/guidance/e-cigarettes-regulations-for-consumer-products for
further information.
Select ‘Add Emission’. You can add further emissions by repeating Step 6. Select
‘Save Emission Details’ before advancing.

Please proceed to the Design tab

Step 7: Design
Under the ‘Design’ tab, enter the mandatory ‘Description’ in the free text field, upload
the mandatory ‘Production File’ by selecting ‘Upload’ and tick the relevant box to
indicate required declarations of conformity for your submission. Provide details for
other fields where relevant to your submission (some of which will require mandatory
document uploads depending on the product type).

If you wish to use the same information from a previously uploaded document, you
can refer to it using the ‘Refer Docs’ tab

Select ‘Save Design Details’ before advancing.

Please proceed to the Validate tab

Step 8: Validate
Submitters intending to supply a product to the Northern Ireland market must upload
their notification via the European Common Entry Gateway (EUCEG). Please see
our webpage for guidance on EUCEG notifications.
In the ‘Validate’ tab indicate if you intend to supply this product in Great Britain by
selecting ‘GB’. If you have also notified this product for supply in Northern Ireland via
EUCEG or intend to do so please select NI & GB.
Below this, sections that are completed will appear with a green tick ( ). Sections
that are incomplete will appear with a red cross ( ). The ‘Submit’ button will not be
made available until all sections have been completed.
Note: if you have not saved a tab, it will appear as incomplete.

Select ‘Submit’ to confirm submission.

Submission ID

After you have selected ‘Submit’, you will receive your submission number in the
‘Submission ID’ tab. Click close to return to the E-cigarettes homepage.

Notifying further products: The system has been developed to allow a submitted
notification to be used as a base template for future notifications allowing notifiers to
submit a range of products swiftly and efficiently.

From the homepage, select edit submissions

Find the notification you have just submitted or want to duplicate and open by
clicking the Case ID. The notification should load prepopulated with submission
details.

Select Submission Type 1 and enter your new product ECID by editing what has
been prepopulated. Click Save Submitter Details, this will return you to the
homepage (please wait 5 minutes for the data to refresh). Go back to Edit
Submissions and find the new Product ECID which you have just created.

*Note: This notification will be prepopulated with information from the original
notification, as such you will need to manually make amendments in this notification
which will differentiate it from the original e.g. nicotine strength, capacity*
Section 2: How to make a Bulk E-cigarette Submission

*Note: The MHRA Portal will only recognise the ‘Export’ file of the XML which is a
condensed file type. This will not work with the ‘Data` file which is the file used to
make changes to the product notification in the EU-CEG XML Creator*

To begin making an E-cigarettes submission, select ‘Bulk Submission’ from the E-

cigarettes tile homepage.

Step 1: Submitter Details

Select Company and Country from drop-down menu.

Enter phone number and email address
Step 2: Submitter Info

If ‘Submitter SME’ or ‘Submitter has VAT’; tick the relevant tick box (and enter
submitter VAT).

Step 3: Uploading XML files

Click upload tab and select XML documents from your files.

Step 4: Submitting XML

Once XML submissions are present under “uploads” you can select submit.
After submitting you will see a Bulk Submission Confirmation message and Email
confirming the submission is available as a draft. Select “close” to return to menu.

Step 5: Review of draft submissions

Select “edit submission” to view your recent draft submission.

*Note: edit only shows recent submissions. “View” displays all historic submissions*
Select case ID to view draft. Select validate to review the success of your upload.
Under the ‘Validate’ tab, sections that are completed will appear with a green tick (
). Sections that are incomplete will appear with a red cross ( ). The ‘Submit’ button
will not be made available until all sections have been completed. You will be required
to manually add documents and CLP Stot Description to required fields.

*Note: if you have not saved a tab, it will appear as incomplete.

Select ‘Submit’ to confirm submission*

Step 6: Activation of Draft Submission

After submitting the draft submission make note of the submission number then click
close to return to the user menu.

Click View Submissions where you will be able to see your notification with an
“Active” status.
*Activation does not confirm assessment and publication of ECIDs on our
website. Notifications will follow due process as per usual*

Notifying further products: The system has been developed to allow a submitted
notification to be used as a base template for future notifications allowing notifiers to
submit a range of products swiftly and efficiently.

From the homepage, select edit submissions

Find the notification you have just submitted or want to duplicate and open by
clicking the Case ID. The notification should load prepopulated with submission
details.

Select Submission Type 1 and enter your new product ECID by editing what has
been prepopulated. Click Save Submitter Details, this will return you to the
homepage (please wait 5 minutes for the data to refresh). Go back to Edit
Submissions and find the new Product ECID which you have just created.

*Note: This notification will be prepopulated with information from the original
notification, as such you will need to manually make amendments in this notification
which will differentiate it from the original e.g. nicotine strength, capacity*
Section 3: How to view previous submissions

Note: this section is strictly for viewing previous details and any changes will not be
saved. Submitters can view ECIDs migrated from EU-CEG, however the full
submission will not available for viewing until providing the next product update. To
make amendments to submissions, please see ‘Section 4: How to submit updates’.

To view previously made E-cigarette submissions, select ‘View Submissions’ from

the E-cigarettes tile homepage.

You can filter your search using the dropdown menus or search fields seen below.

To view a submission for an E-cigarettes product, select the case ID from the list
below the search field.
Section 4: How to submit updates

Select ‘Edit Submissions’ from the E-cigarettes tile homepage.

Begin by selecting the relevant ‘Submission Type’ from the drop-down menu. Note:
As a Type 1 submission has already been submitted for this product, it cannot be
selected from the drop-down menu.

Note: Once you save submitter details the system will return you to the homepage
(please wait 5 minutes for the data to refresh). Return to Edit Submissions and find
the submission you were editing

You can then progress through the application, using steps in ‘Section 1: How to
make an E-cigarettes submission’ as a guide where required, and make
amendments where appropriate to your updated submission.
Progress to the ‘Validate’ tab once all updates have been completed and ensure all
areas are validated with a green tick. Then select ‘Submit.
Section 5: Tips & Troubleshooting on efficiently submitting notifications
- We would recommend you manually submit your first notification and use this
as a template for further notifications which can then be easily edited.

- Use Bulk Submissions for uploading XMLs generated by the EU portal TPD
XML Creator Tool (minus documents).

- You will be unable to view your migrated notifications from the EU Portal.
However, they will be on our system so you will be able to seamlessly upload
your new submission type for that notification.

- Please note if there is a warning that a Type1 does not exist for this
notification then you will need to submit the Type1 before submitting any other
notification types.

- When editing an existing submission and clicking Save Submitter Details you
will return to the Homepage. You will need to wait 5 minutes before you can
reopen the submission from the Edit Submissions (this will ensure data is
refreshed and fully populated).

Section 6: Frequently asked questions

How do we add documents with a Bulk Submission? - Please note that when
making a bulk submission you will be required to manually add documents and CLP
Stot Description to required fields after submitting the bulk upload.

Why do I sometimes lose my submission progress? - We would like to stress the

importance of selecting “save” after completing each tab. This not only ensures that
your current progress won’t be lost but also makes sure that any documents you
upload will appear under “Refer Docs” for ease of reference when uploading
documents in future. Each tab has a save function as evidenced below:
Why am I unable to view submissions made on EUCEG Portal? - Please note
that notifications which have been migrated from the EUCEG Portal to the MHRA
Portal prior to January 1st 2021 will not be viewable on your end. All historic
notifications are available for the MHRA to carry out regulatory functions. The
submissions will be viewable within your profile after XML updates are made.

Why am I unable to upload an XML? - When uploading XML files to the MHRA
submission portal be aware that you may encounter errors if you are using a save
file from the EU XML creator. If you wish to upload EU generated XML files, please
use the ETRUSTEX export XML file. The MHRA Portal will only recognise the
‘Export’ file of the XML which is a condensed file type. This will not work with the
‘Data` file which is the file used to make changes to the product notification in the
EU-CEG XML Creator:

How do I submit Annual Sales Data? - As in previous years the MHRA will be
continuing to accept annual sales for the whole of the UK (Great Britain and Northern
Ireland). Submitters can upload this information to the MHRA Portal in the Product
Presentation tab as per below:
Additionally, you can request a copy of our annual sales template for email
submissions if you prefer. Annual sales notifications should be submitted to the
MHRA by May 20th, the report should cover the whole of the preceding year.
Please note that failure to provide this information to the relevant competent
authority is an offence.

My business is based outside of the UK, can I still submit products for Great
Britain? - For the purposes of submission, the account can be set up/operated by a
business in any part of the world. However, there is a specific field where the
submitter must provide details of the responsible person based in the UK. This would
usually be a legal representative, importer, local office or other suitable
representative for the purposes of legal responsibility in GB. This can be entered at
the Submitter Info page as per below:

I don’t have a submitter ID, what do I do? – At the beginning of the submission
process you will find that the Submitter ID will be auto populated if previous
submissions have been made. In the event one does not exist please select the
Generate Submitter ID tab at which point a unique MHRA submitter ID number will
be generated for you.