NEWS
TPD CORNER
NICHOLAS LITTLEBURY - HEAD OF REGULATORY AFFAIRS AT
DIAMOND BIOPHARM LTD AND THE COMPANIES NICOTINE & TPD SPECIALIST
He has a wealth of European and International experience and
is ex MHRA (Medicines and Healthcare Products Regulatory
Agency). He is also a member of The Organisation for
Professionals in Regulatory Affairs (TOPRA).
“It was a pleasure to speak at the first VapeExpo in Poland
earlier this year and share my thoughts with the industry on
the upcoming TPD regulations. The range of people I spoke to
afterward certainly outlined to me the challenges companies are
facing with the directive. That said, there has been a definite
change of tone in the industry. Up until the turn of the year
people would come up and want a debate on the directive. At
recent events, companies have approached and said “We know
it’s coming, let’s get on with it.
Bearing in mind this approach, I’ll do the same:
Notification Do’s and Don’ts
Q1: Nick, is there an approved list of testing labs we can go
to for the emissions testing?
A lot of companies are getting hung up on this. There appears to
be confusion with the list that exists for tobacco products rather
than e-liquids. To this date there is no approved lab test list to
choose from. I think it would be difficult to put together such a
list of companies as there is not even an approved way of doing
the tests. Regulators will look at putting together a standard
approach to emissions testing in future years. Once they come
up with this new way they will ask e-liquid companies to repeat
all the testing they have previously done. Unsurprisingly this has
caused a fair amount of resentment and will be a big future cost.
At present you still have to do the tests. Either in-house based
on the latest guidance or seek external support from a contract
laboratory who can provide you with reassurance of relevant
expertise and experience. Not the most helpful but that’s the way
it currently is.
Q2. Nick, what is this ‘Adverse Events’ system that needs to
be in place by 20th May 2016?
Yes it is a requirement for producers to have a process (a
system) in place on the 20th May so they can report any potential
safety issues related to their products to the relevant health
authorities such as the MHRA. It does not have to be an all
singing all dancing validated system. It can be controlled as part
of a quality management system and through SOPs. If it’s not
something you know much about you should ensure you seek
appropriate expertise.”
Until next time,
Nick
30 ISSUE 04 VAPOUROUND MAGAZINE