Submission type guidance: Northern Ireland
Updated 16 August 2024
Applies to Northern Ireland
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Introduction
Article 20(2) of Directive 2014/40/EU [TPD] places an obligation on the manufacturers and importers of electronic cigarettes to submit a notification to the competent authorities of the member state of such products they intend to market.
The European Commission has established a common format for the notification of these products in Commission Implementing Decision 2015/2183 of 24 November 2015 establishing a common format for the notification of electronic cigarettes and refill containers. The submission format is set out in the annex to that decision and the submission type is required in section 2 of that annex.
Requirements
Article 20(2) of the TPD requires the manufacturer or importer of an electronic cigarette or refill container to submit a notification for all products intended to be placed on the market.
A new notification is required for each substantial modification of the product.
Information to report
| Submission type | Information |
|---|---|
| 1 | Notification of a new product (6 months advance notice, new EC-ID number) |
| 2 | Substantial modification of information on a previously notified product (6 months advance notice, new EC-ID number with a link to the previous EC-ID) |
| 3 | Update of existing product – addition of information in section 3.B on product format and/or member state(s) notified (new EC-ID version. To note: the 6 months advance notice obligation applies for all additional member states added) |
| 4 | Update of existing product – withdrawal of information in section 3.B on product format and/or member state(s) notified (new EC-ID version. To note: This may include withdrawal of a product or a product format in all or certain member state(s)) |
| 5 | Update of existing product – other information (new EC-ID version) |
| 6 | Updates to information to be submitted annually under Article 20(7) TPD such as sales data (new EC-ID version) |
| 7 | Correction (new EC-ID version) |
Submission type 1
Select this submission type when notifying all new e-cigarettes and refill container products not already on the market on 20 May 2016. You must make this notification at least 6 months before the intended date of placing on the market.
Submission type 2
Select this submission type when a substantial modification is made to a previously notified product. You must make this notification at least 6 months before the intended date of placing on the market. A substantial modification is a change to the product that may have an effect on the human body. Such changes include one or more of the following:
- any change to the qualitative or quantitative composition of the nicotine-containing liquid
- any change to the volume of a refill container, tank or cartridge
- any change to the composition, design or power output of a device which would be likely to affect emissions
Submission type 3
This concerns the addition of information in Section 3.B only. Select this submission type if an existing product is to be launched in one or more additional member states. You must make this update at least 6 months before the intended date of placing on the market in the member state(s) concerned. You should also select this submission type if a new product format is being added in one or more member states.
Submission type 4
This concerns the withdrawal of information in Section 3.B only. Select this submission type if a product, or an individual product format, is to be withdrawn from the market in one or more member states. You should make this update promptly to ensure proper market oversight, for example, that ongoing fees are not charged for the notification by member states.
Submission type 5
This concerns updates to information in sections other than the addition of information in Section 3.B. Select this submission type when updates to sections other than Section 3.B are required but the change is not a substantial modification (see submission type 2 above).
Submission type 6: updates to information to be submitted annually under Article 20(7) TPD
Member States may oblige manufacturers and importers to submit the annual information required under Article 20(7) of the TPD via the EU-CEG. Select submission type 6 when doing so. This information includes annual reports on sales volume, by brand name and type of product and the mode of sale of the products. Where available, this report should also include:
- information on the main types of current users and the preferences of various consumer groups including young people and non-smokers
- executive summaries of any market surveys carried out on these
Submission type 7: correction
Select this submission type to rectify errors in previously submitted information such as typos or spelling corrections.