Manufacturers launch new products into the UK market (GB and Ni)
a) The trpr regulation stipulates that manufacturers of new e-cigarettes and filled container products must submit a notice to MHRA 6 months before they intend to put their products on the GB and / or Ni market. However, MHRA stipulates that once the notice is published on the MHRA website, manufacturers can launch products in the notified area without waiting for the rest of 6 months.
b) Producers who only supply products to Ni only need to notify through the EU TPD notification portal euceg. This notification is also reviewed and issued by MHRA. Products that have been substantially modified will be regarded as new products and must be re announced.
c) As long as the manufacturer lists the importer's brand name and the details of rebranded products in the notice when submitting the notice of GB and Ni, the importer does not need to submit a duplicate notice.
d) If the manufacturer provides products with multiple brand names in GB and Ni, it can include all brand names of the same product in a separate notice in each region without paying additional notice fee.
e) Trpr does not specify and require where e-cigarettes and refilled containers must be tested. However, notifiers need to meet the standards of any test conducted, because they must submit a statement that they are fully responsible for the quality and safety of the product when the product is put on the market and used under normal or reasonably foreseeable conditions.
Definition and requirements of e-cigarette to be notified
a) E-cigarette replacement parts that may contain nicotine need to be notified only if they have not been notified as part of the equipment or e-cigarette kit.
b) As the same replacement part of the advertised electronic cigarette product, if it is clearly stated on the product label which advertised product the part is used for, it does not need to be re advertised separately.
c) Any different replacement parts, especially those that change the consumer safety characteristics of the product (e.g. by changing its refill capacity), need to be notified separately. Recombinable devices also require notification.
d) Manufacturers, importers and distributors of e-cigarettes are also required to comply with the restrictions on hazardous substances in electrical and electronic equipment (RoHS) 2012, which limits the content of some hazardous substances in specific electrical equipment (including e-cigarettes).
a) Notification fee: £ 150 (according to the notification of the United Kingdom of Great Britain and Northern Ireland and ECID).
b) Annual and substantive revision costs will be reviewed in 2021.
c) MHRA will review the charge level based on the number of notifications received each year.
d) Submitters who use the same ECID for the same product in GB and Ni only need to pay a notification fee.
e) If the same product is advertised with different ecids in these two regions, there will be two notification fees, which need to be paid separately.
Submit payment via MHRA
a) From 23 August 2021, the submitter must pay the notification fee using the integrated system provided as part of the MHRA submission. After confirming the submission, the submitter downloads the invoice and pays the notification fee through MHRA "submission". The payment of documents submitted through MHRA and euceg will cover the notification fee of GB and Ni. The submission payment of GB notification must be completed using the MHRA submission portal payment option.
b) If you do not want to evaluate the announcement or submit the fee for the time being, you can save the draft and complete the submission and payment at a later time. However, MHRA's evaluation team was unable to review the unpaid notices in the system.
c) If you only intend to sell products in Ni, you can continue to use the current euceg service and pay online invoices with debit card or credit card. However, payment systems using euceg cannot process GB submissions.
d) The payment currency can only be GBP.