Does this impact the current LVL patch testing policy?
Please be aware that there are no changes to our patch testing guidelines (please see LVL Patch Test Guidelines for a reminder on our policy). The guidance for patch testing clients and the method of patch testing remains the same, the only change is that you will no longer be able to purchase the patch test kits.
Who are the MHRA?
The Medicines & Healthcare Products & Regulatory Agency (MHRA) is an executive agency sponsored by the UK government’s Department of Health and Social Care. They regulate medicine, medical devices, and blood components for transfusion in the UK.
Why has the MHRA asked us to stop selling our patch test kits?
Here is the reason given from the MHRA in their communication with us:
“If a company places on the market a product containing a substance or combination of substances which has the intended purpose of testing for an allergy to those substances, the product is likely to be considered to be a medicinal product which falls under the definition set out in regulation 2(1)(b)(ii) of the Human Medicines Regulations 2012.
The purpose of the LVL Patch Test product (also, we now note, the LVL CeraLashLift System Patch Tests) is to test for any allergy to the substances that it contains. Since the action of testing a human being for an allergy to a particular substance constitutes, by definition, the making of a medical diagnosis, the product will necessarily fall under medicines regulations.
The MHRA is responsible for the administration and enforcement of medicines legislation in the UK. In the UK, medicinal products which are placed on the market are required to be authorised in accordance with The Human Medicines Regulations 2012 (S.I.2012/1916). Among other things these provide that, unless exempt, no medicinal product shall be placed on the market unless an appropriate authorisation has been granted by the licensing authority.”
Can I still purchase LVL patch tests?
You have until 30th September to order the current patch test products, and sales will cease from 1st October. This is the deadline given to us by the MHRA. You will still be able to continue to use any patch tests that you have after this date.
How will I perform patch tests when I run out of patch test kits?
Patch tests will now need to be carried out using a sample of your treatment products.
There are no changes to carrying out your tint patch tests.
For the Step 2 LVL CeraLashLift and Step 3 LVL CeraLashFix that are in a sachet, or the classic LVL blister packs, our advice is to puncture the blister/sachet with the Pro Lash Tool to create a small opening that allows you to squeeze out just enough product. On average, you should able to perform up to 8 patch tests per LVL CeraLashLift sachet, and up to 6 patch tests per classic LVL blister pack.
It’s best practice to perform patch tests in person, however we understand this is not always possible. If you do post out patch tests to your clients, you can send out a full blister pack or relevant sachets, or decant a small amount into separate, sealable pots, as you would currently with tint. Standalone patch test instruction cards will still be available to order, so you can still send out clear instructions and keep a record of the completed patch test.
It is important you check your insurance policy to ensure you are covered to post out patch tests.
How long will open blisters/sachets last?
Once you have opened a blister/sachet for use as a patch test, we recommend you cover the opening with tape and store in a fridge for up to two weeks.
We sincerely apologise for any inconvenience this may cause and hope you can understand that this decision is beyond our control.
If you have any questions on the changes, please feel free to email [email protected] or call 01977 655620.
If you have any questions on this patch test directive, you can contact the MHRA directly by calling their customer service line on 0203 080 6000.