# Guidance on the submission and content of notifications for Northern Ireland Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/a78861fa-7135-404a-989b-06497dade43d Type: Detailed Guide Published: March 24, 2022 > This regulatory guidance document issued by the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the mandatory notification requirements for producers of electronic cigarettes and refill containers. Operating within the regulatory framework of the Tobacco Products Directive and Commission Implementing Decisions (EU) 2015/2183 and 2016/586, the document establishes the technical standards for product safety and market entry. Required actions for manufacturers and importers include the submission of comprehensive product notifications via the EU Common Entry Gate (EU-CEG) portal, covering critical data points such as nicotine dosage, emissions, ingredient lists, and product presentation. The guidance emphasizes that producers must ensure their refill mechanisms meet specific technical standards and that all products include appropriate instructions for use and labeling. Beyond the initial submission, companies are required to perform annual reporting and maintain robust due diligence and vigilance systems to monitor product safety. While this document is a general guidance framework rather than a report of a specific company inspection or violation, it serves as the definitive standard for compliance. Producers are directed to ten specific technical chapters to ensure their products meet legal requirements, with technical support for the submission process provided by the European Commission's IT support teams. --- ## Content 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 .