GPSR 2005 compliance checklist:
Have you emissions tested with nicotine (in use safety testing)?
Have you checked your formulations for toxicology / safety?
Have you checked your products for banned substances (anything
banned for TPD is banned for short-fill)?
Have you produced SDS (MSDS) sheets for your products?
Remember SDS sheets are not just driven by nicotine, flavours
have a large impact.
United Arab Emirates
The other big news that is moving the industry is the opening up of
the United Arab Emirates for the vaping industry, and the news is a
little good and little bad.
Basically, the UAE wants TPD-level standards and notification but
with some key differences that do add to the complexity of and
expense of the process.
Firstly, you have to show your products are stable for the duration
of their shelf life. That requires a stability study in an accredited
laboratory, not a big job but slow and this has some costs associated with it.
Then you need to do your emissions tests in an accredited laboratory.
For the TPD, you just need validated tests, not accredited tests, so
it’s a slightly higher bar.
Finally, you need to manufacture the product to ISO standards, which
for a lot of companies is something they are already doing. For others,
it would be a big step up.
Once you have all this data ready you need to submit it for approval.
You can’t sell until you’ve been approved. The filing costs are £1,500
(approximate estimate) and you can file 20 SKUs at a time. So, the
market is there and I am sure a lot of companies will be heading over
there. We have had several enquiries to date.
For more information on any of the topics covered in this feature,
contact ADACT Medical on +44 1302 98 60 88 or email
[email protected].
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