This month, we'll cover checking the status of registered products, avoiding delays in product announcements, MHRA registration submissions for 2022 updates and product naming proposals.
Avoid Product Launch Delays - Troubleshooting
Product registration should be submitted six months prior to market release. If the registered product is published by MHRA before the end of this period, it can be sold on the market. Since the launch of the Integrated Publishing System in August, the average publication time for compliance registrations is 3 weeks. The time it takes for a product to reach published status will be determined by the quality of the initial submission and the time it takes to complete the corrective actions required by MHRA.
Delays in obtaining publication status in a timely manner are often caused by a number of reasons:
The submitter failed to perform the necessary corrective actions as required by MHRA regarding missing data (common example - missing toxin data, no UK representative information provided)
The submitter fails to notify MHRA in a timely manner after taking corrective action, and MHRA will not conduct a reassessment until the submitter responds
● The submitter has not paid the fee, and in this case, has not been assessed (this includes partially paid invoices and payments that do not provide the required information - invoice reference number, MHRA account number, etc.).
● Submitter mistakenly set up account when submitting registration at MHRA
● Submitters fail to follow published guidelines, which requires IT intervention before further submissions
You will be notified in writing when any of these issues affect your submission.
All published guidelines must be followed, which can be found in the "Submission Guidelines" in MHRA submissions and on the home page of our website.
Please Note: It is in your best interest to ensure that your notice is complete and compliant with regulatory requirements at the time of submission. Incomplete submissions will receive an email titled "Checking of Notifications" in which we outline any issues that need to be addressed.
These ECIDs will be placed on hold pending a response from the submitter confirming that corrective action has been taken. This effectively means that your submission will be placed at the back of the ECID queue that needs to be re-evaluated, which in turn can mean significant delays no matter how quickly corrective action is taken. Products that are on hold will be re-evaluated in sequence and requests for immediate re-evaluation and publication will not be accepted. The TPD Review Team will notify you when the reassessment is complete, and the ECID will then be published in the next update of the published list (assuming corrective actions are sufficient).
Submissions will not be reviewed for update by MHRA until MHRA has received written notification of completed corrective actions from the submitter. To ensure your correction is reviewed, you must reply directly to the email titled "Checking of Notifications". Please do not reply to this email with other questions that differ from the subject of this email. If you need assistance with other matters (including product submissions not mentioned in our initial communication), you must outline the issue in a separate email.
MHRA Registration Submission - 2022 Update
MHRA has been reviewing industry feedback on the submission portal throughout 2021 and has developed a series of updates to improve the experience for submitters and MHRA assessors.
Information - January 2022
Submitters can now access our previously published information through the "Submission Guidance" option in the MHRA submission portal.
Reference Documentation - January 2022
MHRA will provide a new reference file system that will remove all duplicates from the submitter reference file search list and provide the ability to search your previous files by ECID/GBID, file title and submission ID. A series of enhancements to the system will be available from March 2022.
Centralized Submission of Payments - March 2022
From March 2022, submitters will be able to make collective payments for products saved as drafts, up to a total of £20,000 per payment. From April 2022, MHRA will no longer issue manual invoices.
Email for automated invoices - March 2022
After each successful payment, an automated email will be sent to the email address you provided during submission. In addition to this, you can also search and download invoices if further copies are required.
Automatic principal verification - March 2022
If the GB authorized representative is not provided in the registration, the registration data will not be successfully verified. This information must be provided in each registered "affiliate company".
Automatic Mandatory Data Request - No Toxicology Data Exist - March 2022
From March 2022, all submitters will be required to provide evidence of a safety assessment of ingredients for which there is no publicly available data, as previously communicated in our December 2020 newsletter. Authentication will not succeed until this information is provided. Further review of this data will be performed by assessors to suit MHRA requirements.
"While the requirement to provide ingredient toxicology data remains the same, the required fields have changed. When using the MHRA submission portal, it is now mandatory to upload documents for all aspects of toxicology data (CMR, cardiopulmonary toxicity, etc.).
While data may not be available for every aspect, the system still needs to upload. If no data is available on an aspect of the toxicological requirement, details of the search performed (including details of the search terms used and the database) can be uploaded. The search should be broad, finding data from multiple sources. Information from published studies showing no harmful effects is effective.
If toxicity studies or information cannot be found on any of the required aspects, the suitability of the ingredient for use in a product should be questioned. Manufacturers must ensure that their products can be considered safe and cannot assume product safety without available data. In the absence of information, producers should conduct their own safety assessments. Ambiguous statements about lack of data/study in uploaded toxicology data will not be accepted without evidence of assessment, and documentation will not be accepted.
Please Note: Removing ingredients from submission data in an attempt to circumvent this requirement is illegal and may result in permanent product removal and/or account cancellation.
Product Showcase - Use Non-Compliance Clause
The individual packaging and any outer packaging of e-cigarettes and e-liquid fillers (such as bottled e-liquids or refill cartridges) and the labelling of the product itself must not contain any of the following elements or characteristics: (a) By its characteristics, health effects, risks or releases create the false impression to advertise the product or encourage its consumption," which we interpret as including a prohibited misleading safety claim, such as the product being "safe" or "risk free." It would also preclude the use of the Claims of any health benefits of the product.
Submitters are also cautioned that beneficial claims for the use of the product or its ingredients, including any implication of energy or health (and related terms) effects. It is also prohibited to describe any ingredient as being of "natural" origin or organically produced. It does not prohibit accurate representations of facts relating to specific ingredients, ingredients or emissions that are not listed in tobacco products. We interpret these two terms to prevent the product from being described as "light", "mild" or similar terms.
Section 38 of the Tobacco and Related Products Regulations states:
Product naming requirements
38. (1) No person shall manufacture or supply electronic cigarettes or e-liquid refills except in accordance with subsections (2) to (4).
(2) The unit packaging and any container of an e-cigarette or refill container shall not contain any element or feature falling under subsection (3).
(3) If an element or feature falls under this subsection, it—
(a) Advertise e-cigarettes or liquid refills, or encourage their consumption by their characteristics, health effects, risks or emissions;
(b) recommending a particular e-cigarette or liquid refill-
(i) less harmful than other e-cigarettes or liquid refills,
(ii) have other health or lifestyle benefits and are less harmful than other e-cigarettes or liquid refills,
(iii) have other health or lifestyle benefits,
In conclusion, the Chartered Trading Standards Body and the MHRA consider that the use of terms such as "energy", "mild" and related or similar terms in product names is a clear breach of this regulation.
From January 2022, MHRA will review product registrations with such issues and not publish them until corrective action is taken. If your current offering does not meet this requirement, the MHRA will write to you with a timetable for corrective action. MHRA recommends that you start the process immediately as such products may currently be seized by licensed trading standards bodies. For more information, see our published guidelines
