Mr Ripple
Legend
- Joined
- Jun 2, 2017
- Messages
- 14,930
2021 TPD Update.........
Not sure I've got my head round this yet but it looks like every product now released onto the UK market needs to be registered and subject to a registration fee of £150 per product.
I'm assuming having skimmed read the details that this could be devastating to small manufacturers and modders like @vapesmarter
Anyone else digested this yet?
Maybe @Mawsley has been all over it already but I've not seen it mentioned.
https://www.gov.uk/guidance/e-cigarettes-regulations-for-consumer-products
Advice for producers
Putting a new product into the UK market (Great Britain and Northern Ireland)
Producers of new e-cigarette and refill container products must submit a notification to the MHRA six months before they intend to put their product on the market in Great Britain and/or Northern Ireland. Once your notification has been published on our website you can launch the product in the notified region. If your notification has been published, you do not need to wait for the remainder of the 6 month period to elapse before you place your product on the market in the notified region.
Note: Supplying a product to the UK market will require separate notifications for a product via EUCEG (Northern Ireland) and the MHRA submission portal (Great Britain).
A product which has been substantially modified will count as a new product and must also follow this process. Further information regarding what qualifies as a substantial modification can be found in the guidance on submission type below.
If the manufacturer has submitted both a Great Britain and Northern Ireland notification for the specific product you import, then you do not need to submit a duplicate notification. Similarly, if the manufacturer has notified details of a product that you have re-branded, and your brand name is listed in the manufacturer’s notification, then you do not need to submit a duplicate notification.
If you make your product available in Great Britain and Northern Ireland under several brand names, you will be able to include all the brand names for the identical products in a single notification in each region, for no additional fee. Each brand must be listed on the notification as a separate presentation and may not be supplied in Great Britain and Northern Ireland until published on the relevant list for that region.
The TRPR does not include any requirements as to where testing of e-cigarettes and refill containers 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.
Other requirements for e-cigarettes
Replacement e-cigarette parts that could contain nicotine only require notification if they have not already been notified as part of a device or e-cigarette kit. Identical replacement parts that have already been notified as part of another notified e-cigarette product do not need to be separately re-notified if it is clear on the labelling what notified product the part is for. Any non-identical replacement part, particularly one that alters the consumer safety profile of a product (for example by changing its refill capacity), would require a separate notification.
Rebuildable devices come within the definition above and require notification. See the product type guidance for further advice.
Manufacturers, Importers and Distributers of e-cigarettes also need to comply with the Restriction of Hazardous Substances in Electrical and Electronic Equipment Regulation 2012 (known as RoHS). These regulations limit the amount of certain hazardous substances in specific electrical equipment, of which e-cigarettes are included. They place obligations onto Manufacturers, Importers and Distributers of e-cigarette models. Details can be found here. The regulation is enforced by the Office for Product Safety and Standards, part of the Department for Business, Energy and Industrial Strategy.
Guidance on the submission and content of notifications for Great Britain
Before getting started
Registering to make submissions to the MHRA from 1 January 2021 provides guidance on how to use MHRA Submissions, including for e-cigarette information.
Ensure that you have watched the videos and have referred to the user reference guides prior to clicking on the link in the Getting Started section.
Three short video demos are provided below which cover all aspects of the user access management process - these steps will enable your organisation to gain access and manage user permissions for using MHRA Submissions. You can access all three videos on Sharefile.
User Reference Guide – Gaining Access to MHRA Submissions (PDF, 661KB, 11 pages)
User Reference Guide – Managing users on MHRA Submissions (PDF, 770KB, 12 pages)
Once you have an MHRA Submission Portal account, you can continue with the application process. The MHRA have published guidance to help you with this. You can find this guidance the link below:
User reference guide – E-cigarettes Submissions
If the MHRA submission portal is providing an option to generate new submitter ID instead of pre-populating your EU submitter ID please report this to the MHRA via the ‘Help and Support’ tile on MHRA submission portal before completing any submissions.
Once you have validated the submitter ID assigned by the MHRA submission portal and it is in line with your EU submitter ID you will have an option to raise a request to update your company display name. A request can be raised via the ‘Help and Support’ tile.
NOTE- Company name displayed on the MHRA submission portal is also used in the extract published on our MHRA gov website.
If your company ownership has changed and you require a new company ID on the MHRA submission portal then you can raise a ticket via the ‘Help and Support’ tile for a change of ownership.
Please note that the MHRA does not provide an XML creator. Notifications to the MHRA can be provided via existing XML documents or manually using our bulk uploader or online form.
To receive fee reduction for both Northern Ireland and Great Britain products must retain the same ECID in both regions. The regulations enable submitters to pay a single fee for Great Britain and Northern Ireland. Changes to the ECID between regions will result in two unique product identifiers which will be charged accordingly.
If you have any difficulties, please contact the portal’s technical team directly via the email addresses below:
Not sure I've got my head round this yet but it looks like every product now released onto the UK market needs to be registered and subject to a registration fee of £150 per product.
I'm assuming having skimmed read the details that this could be devastating to small manufacturers and modders like @vapesmarter
Anyone else digested this yet?
Maybe @Mawsley has been all over it already but I've not seen it mentioned.
https://www.gov.uk/guidance/e-cigarettes-regulations-for-consumer-products
Advice for producers
Putting a new product into the UK market (Great Britain and Northern Ireland)
Producers of new e-cigarette and refill container products must submit a notification to the MHRA six months before they intend to put their product on the market in Great Britain and/or Northern Ireland. Once your notification has been published on our website you can launch the product in the notified region. If your notification has been published, you do not need to wait for the remainder of the 6 month period to elapse before you place your product on the market in the notified region.
Note: Supplying a product to the UK market will require separate notifications for a product via EUCEG (Northern Ireland) and the MHRA submission portal (Great Britain).
A product which has been substantially modified will count as a new product and must also follow this process. Further information regarding what qualifies as a substantial modification can be found in the guidance on submission type below.
If the manufacturer has submitted both a Great Britain and Northern Ireland notification for the specific product you import, then you do not need to submit a duplicate notification. Similarly, if the manufacturer has notified details of a product that you have re-branded, and your brand name is listed in the manufacturer’s notification, then you do not need to submit a duplicate notification.
If you make your product available in Great Britain and Northern Ireland under several brand names, you will be able to include all the brand names for the identical products in a single notification in each region, for no additional fee. Each brand must be listed on the notification as a separate presentation and may not be supplied in Great Britain and Northern Ireland until published on the relevant list for that region.
The TRPR does not include any requirements as to where testing of e-cigarettes and refill containers 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.
Other requirements for e-cigarettes
Replacement e-cigarette parts that could contain nicotine only require notification if they have not already been notified as part of a device or e-cigarette kit. Identical replacement parts that have already been notified as part of another notified e-cigarette product do not need to be separately re-notified if it is clear on the labelling what notified product the part is for. Any non-identical replacement part, particularly one that alters the consumer safety profile of a product (for example by changing its refill capacity), would require a separate notification.
Rebuildable devices come within the definition above and require notification. See the product type guidance for further advice.
Manufacturers, Importers and Distributers of e-cigarettes also need to comply with the Restriction of Hazardous Substances in Electrical and Electronic Equipment Regulation 2012 (known as RoHS). These regulations limit the amount of certain hazardous substances in specific electrical equipment, of which e-cigarettes are included. They place obligations onto Manufacturers, Importers and Distributers of e-cigarette models. Details can be found here. The regulation is enforced by the Office for Product Safety and Standards, part of the Department for Business, Energy and Industrial Strategy.
Guidance on the submission and content of notifications for Great Britain
Before getting started
Registering to make submissions to the MHRA from 1 January 2021 provides guidance on how to use MHRA Submissions, including for e-cigarette information.
Ensure that you have watched the videos and have referred to the user reference guides prior to clicking on the link in the Getting Started section.
Three short video demos are provided below which cover all aspects of the user access management process - these steps will enable your organisation to gain access and manage user permissions for using MHRA Submissions. You can access all three videos on Sharefile.
- User registration – the end to end process for adding an initial company administrator
- Add a new user – how to add an internal colleague as a user or company administrator
- Add a new external user – how to add a third party consultant/consultancy as a user or company administrator
User Reference Guide – Gaining Access to MHRA Submissions (PDF, 661KB, 11 pages)
User Reference Guide – Managing users on MHRA Submissions (PDF, 770KB, 12 pages)
Once you have an MHRA Submission Portal account, you can continue with the application process. The MHRA have published guidance to help you with this. You can find this guidance the link below:
User reference guide – E-cigarettes Submissions
If the MHRA submission portal is providing an option to generate new submitter ID instead of pre-populating your EU submitter ID please report this to the MHRA via the ‘Help and Support’ tile on MHRA submission portal before completing any submissions.
Once you have validated the submitter ID assigned by the MHRA submission portal and it is in line with your EU submitter ID you will have an option to raise a request to update your company display name. A request can be raised via the ‘Help and Support’ tile.
NOTE- Company name displayed on the MHRA submission portal is also used in the extract published on our MHRA gov website.
If your company ownership has changed and you require a new company ID on the MHRA submission portal then you can raise a ticket via the ‘Help and Support’ tile for a change of ownership.
Please note that the MHRA does not provide an XML creator. Notifications to the MHRA can be provided via existing XML documents or manually using our bulk uploader or online form.
To receive fee reduction for both Northern Ireland and Great Britain products must retain the same ECID in both regions. The regulations enable submitters to pay a single fee for Great Britain and Northern Ireland. Changes to the ECID between regions will result in two unique product identifiers which will be charged accordingly.
If you have any difficulties, please contact the portal’s technical team directly via the email addresses below:
