With the implementation of TPD2 regulations just around the corner, we thought it would be helpful to remind you of the deadlines applicable under TPD2. To help, we also want to give you a timeline of required actions that need to be taken to ensure that we are fully prepared to process the analysis and notifications of your products before the deadlines. This will ensure the continuity of your products in the market.
Summary of Timeline Imposed by TPD2
20th May 2016 – TPD2 comes into effect
No new products can be placed into market unless they are notified to the MHRA six months prior to they are placed on market. MHRA will accept production notifications through a European Common Entry Gate (EU-CEG) notification portal.
Transitional agreements have also been put in action to allow the placement of new products between 20th May and 19th November 2016 provided that they are notified to the MHRA on 20th May 2016.
20th November 2016 – Existing Products Notification Submission Deadline
For all existing products that are already in the market before 20th May 2016, a notification can be submitted until 20th November 2016. Any products that are not TPD2 compliant in terms of labelling and product composition can be produced until 20th November 2016 and retailed until 20th May 2017.
After 20th November 2016, no existing products can be produced if they do not comply with the TPD2 regulations and if no notification has been submitted to the MHRA by this date.
20th May 2016 and Onwards –Problems, Complaints and Corrective Action Required
Customers and end-users who report any problems or complaints with e-cigarettes or refill containers will have to report them either to the producers directly or by contacting the Citizens Advice Bureaux. Further to this, consumers can also report any adverse incidents to the MHRA via a dedicated reporting channel on the Yellow Card Portal.
From 20th May 2016, the TPD2 regulations will obligate businesses to inform MHRA if they have reason to believe a notifiable product is unsafe, not of good quality or not compliant with TPD2 regulations. When submitting such reports to MHRA, the Manufacturer/Importer must also provide details of the risk to human health and safety along with any corrective action taken.
TPD Regulations also obligate Manufacturers/Importers to investigate and report any adverse effects incidents along with the outcome of any corrective action that they may have taken in line with currently requirements of the TPD2 Article 20.
Actions Taken by Xyfil Prior to TPD2 Implementation
As the implementation of TPD2 draws closer, we are working hard on analysis and compiling data in accordance with the TPD2 regulations. Although the EU notification portal (EU-CEG) is not yet active, a common format for the notification of electronic cigarettes and refill containers has been released which is the basis upon which the EU-CEG will be designed. Therefore, notifications submitted using this common format will be accepted.
We are also excited to announce that we are currently in the process of upgrading our facilities. Within two weeks we will have moved into our new facility which is fully equipped with an ISO 7 clean room and upgraded analytical laboratory, production and packaging facilities to ensure that all products manufactured by Xyfil LTD will be TPD2 compliant. We are also collecting health and safety data in line with the TPD2 regulations on the ingredients used in our products.
Timeline of Actions to be Taken by Xyfil Customers
Existing Customers Who Are TPD2-Enrolled
For customers who have already submitted a priority list of SKUs to be notified under TPD 2 and paid your deposit (aka ‘TPD2-enrolled customers’), no action is required. You can sit back and relax knowing that we are already working to make your products TPD2 compliant. We ensure that we will submit the notification of your products before the start of November 2016 to assure a continuous supply of your products in the market. To make our processes completely transparent, you will soon be able to track the progress of TPD2 compliance for your products by logging in to your account for the Compliance Portal on the Xyfil website.
Existing Customers Who Are Not Yet TPD2-Enrolled
For existing customers who haven’t submitted a priority list of SKUs and/or paid a deposit, we recommend doing this as soon as possible. We estimate that you should submit and pay your deposit by 30th April 2016 to ensure your products are notified before 19th November 2016.
If you submit a priority list and/or pay your deposits after 30th April 2016, we will not be able to guarantee that your products will be notified to the MHRA by 19th November 2016. This is due to requirements for in-depth e-liquid analysis. By submitting your SKUs and paying your deposit prior to 30th April 2016, we guarantee that your products will be notified to the MHRA before the deadline.
New and Existing Customers with New Recipe Formulations
In order to take advantage of the transitional arrangements made by the TPD2 regulations, we request that all customers finalise any new recipes to be formulated before the 22nd April 2016. This will ensure that your new products are introduced to the market before 19th May 2016 to allow you to make use of the transitional arrangements.
Customers with Non-TPD2 Compliant Products
Lastly, we request that all our valuable customers forecast and place orders of non-compliant products before 3rd October 2016. This will ensure that they are produced before 19th November 2016 and that there will be a continuous supply to retail the products until 20th May 2017 when the deadline for non-TPD2 compliant products comes into effect.