MHRA (Medicines and Healthcare products Regulatory Agency) stands as the competent authority in the UK for the notification scheme of nicotine-containing vaping products, encompassing e-cigarettes and refill containers, across both Great Britain and Northern Ireland. This agency, in collaboration with other regulatory bodies, is entrusted with executing several mandates under Part 6 of the Tobacco and Related Products Regulations 2016 (TRPR), as amended.

An Explanatory Memorandum sheds light on these changes from a policy perspective, elucidating the regulatory shifts that have taken place.

The regulatory amendments of 2020, facilitated by the Tobacco Products and Nicotine Inhaling Products (Amendment etc) (EU Exit) Regulations 2019, enshrine the Withdrawal Agreement and the Northern Ireland Protocol’s obligations into law, modifying the applicability of the Tobacco and Related Products Regulations 2016 in Great Britain and Northern Ireland.

From January 1, 2021, the new regulations delineate the requirements for the notification of new products, stipulating that:

• Producers aiming to enter the Northern Ireland market must utilize the EU Common Entry Gate (EU-CEG) system for the notification of tobacco and e-cigarette products.
• Notifications for products intended for the Great Britain market should be submitted through the domestic system of Great Britain.
• Notifiers are obliged to pay a single fee for placing their products in either the Great Britain or Northern Ireland markets, with the same fee applying for notifications across both markets.
• The term “producer” encompasses any entity that manufactures or imports these products, or anyone who re-brands a product as their own. Retailers, unless they also qualify as producers, are not required to submit notifications for the products they sell.

Our MHRA notification assistance provides a comprehensive and customized service to navigate this new regulatory landscape successfully.

Our MHRA Notification Process Includes:

• Custom Regulatory Analysis: We begin with a detailed assessment of your products to precisely identify the necessary MHRA notifications, based on the latest guidelines and regulatory requirements.
• Industry Expert Assistance: You will benefit from the support of a dedicated personal assistant, well-versed in the complexities of MHRA regulations. This singular point of contact will coordinate the entire notification process, serving as a bridge between your company and the regulatory agency.
• Document Preparation and Submission: Our team will prepare and submit all required documentation for the notification, ensuring every detail meets the stringent MHRA standards.
• Secure Document Management: All documentation related to your notifications will be securely stored within our IT systems, accessible at any time through a dedicated section.
• Customized Service: We offer to manage the entire notification process on your behalf, from initial registration to final submission, or to tailor the service to meet your specific needs.
• Ongoing Support: We provide a notification declaration and continuous follow-up with the MHRA and other competent authorities, ensuring full mediation and assistance in case of further inquiries.