Advice for producers of e-cigarette and vape products

AI Summary

This guidance document from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the mandatory notification requirements for producers of e-cigarettes and refill containers. Under Part 6 of the Tobacco and Related Products Regulations (TRPR) 2016, any entity that manufactures, imports, or re-brands these products must submit detailed information before placing them on the UK market. Although this is a general guidance document rather than a specific inspection report, it identifies potential compliance issues regarding improper registration and incorrect fee payments across different UK regions. The regulatory framework is supported by Commission Implementing Decision (EU) 2015/2183, which dictates the format and content of these notifications. To remain compliant, producers must first verify if a supplier has already submitted a notification to avoid duplicates. Required actions include registering for an account on the MHRA Submission Portal, managing user access via provided tutorials, and submitting product data through the European Common Entry Gate (EU-CEG). Producers must ensure their Submitter ID remains consistent with their European ID to qualify for reduced fees in Great Britain and Northern Ireland. While the MHRA does not offer an XML creation tool, it accepts manual uploads and existing XML documents. Technical issues should be reported directly to the MHRA submissions team with supporting evidence.