Advice for Producers of E-Cigarette/Vape Products

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) provides this guidance for entities manufacturing, importing, or re-branding e-cigarettes and refill containers in the United Kingdom. Operating under the regulatory framework of Part 6 of the Tobacco and Related Products Regulations (TRPR) 2016, producers must ensure all products are properly notified before entering the market. While this document does not list specific inspection dates or past violations, it outlines mandatory steps to avoid regulatory non-compliance. Required actions for producers include registering for the MHRA Submission Portal and the European Common Entry Gate (EU-CEG) to submit product information. Companies must accurately manage their Submitter IDs and can utilize existing XML documents or manual uploaders for their submissions. The guidance emphasizes that product data must adhere to the Commission Implementing Decision (EU) 2015/2183 and the associated Data Dictionary. To minimize costs, a single fee is applicable for both Great Britain and Northern Ireland if the product maintains a consistent European Commission Identification (ECID). Additionally, multiple brand names for identical products can be listed under a single notification at no extra cost. Failure to follow these notification protocols and technical requirements would prevent legal sale within the UK.