Guidance on the submission and content of notifications for Northern Ireland
Guidance on the submission and content of notifications for Northern Ireland
Applies to Northern Ireland
The format and content of notifications are set out in the Commission Implementing Decision (EU) 2015/2183 on e-cigarettes.
Details of the information notifications are required to contain are set out by the Commission in the 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 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 regulators and other member states and discussed at the European Commission Working Group on notification of e-cigarettes and refill containers.
Chapter 1 - Submitting Notifications EUCEG Guidance NI.docx Chapter 1.1 -Submission Type Guidance NI.docx Chapter 2 - Product Type Guidance NI.docx Chapter 3 - Emissions Guidance NI.docx Chapter 4 - Nicotine Dose Guidance NI.docx Chapter 5 - Presentation Guidance NI.docx Chapter 6 - Ingredient Guidance NI.docx Chapter 7 - Annual Reporting Guidance NI.docx Chapter 8 - Labelling Guidance NI.docx Chapter 9 - GENERAL ADVICE ON DUE DILLAGENCE .docx Chapter 10 - GENERAL ADVICE ON VIGILANCE .docx
Sources of further information
European Commission pages on tobacco policy – for the text of the Tobacco Products Directive and Implementing Acts, notes of Commission meetings, etc
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 difficulties in obtaining a submitter ID, please contact SANTE-SUBID-EUCEG@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.
Please note that the MHRA does not run the notification portal or XML creator. If you have any difficulties, please contact the portal’s technical team.