Brexit and Pharmacovigilance reporting. What happens if there is no deal?
It’s becoming clear that
the United Kingdom leaving the EU on the 29th March without a deal is
a very real possibility. The UK Government’s position remains unchanged in that
a deal with the European Union remains its top priority. However, the clock is ticking,
and the government has stated that as a responsible legislator it must make
plans for every eventuality and this includes no deal.
The MHRA, as a government body, is
therefore making preparation that, in the event of no deal, regulatory
submissions (including pharmacovigilance) and notifications can continue to be
made to the UK authority. The monitoring of the safety of medicines on the
market is currently coordinated at EU level. However, if there is no deal then
the MHRA will have primary responsibility for the conduct and oversight of all
pharmacovigilance activities in relation to UK Marketing Authorization,
certificates of registrations and traditional registrations. Sharing of common
systems, formal exchange and recognition of data submitted for regulatory
activities between the UK and EU countries will cease.
What does
this mean for me as a Marketing Authorization holder?
The current EU submission process and
solution remains in place until 29th March. After the 29th
March, in the event of no deal Brexit, if you fall into one four groups, then
your organization needs to ensure that they have access to MHRA Submissions.
Those groups are -
§ all
pharmaceutical companies involved in making medicines regulatory submissions
and vigilance activities
§ all
medicines clinical trial sponsors wishing to submit clinical trial applications
to the Agency
§ e-cigarette
producers
§ brokers
of medicinal products
After March 29th
if Britain leaves the EU without reaching an agreement, then new guidelines and
process for regulatory submissions direct to the MHRA of all pharmacovigilance
data (UK and non-UK ICSRs and SUSARs) will come into place and a new MHRA gateway for UK
submissions will be available. This will also apply to all current
Eudravigilance Gateway users seeking access to the MHRA submissions portal.
Organizations affected must
be registered and approved on the new system before they are able to submit
data. Registration for the new gateway is open now and the advice from the MHRA
is to register as soon as possible as it can take up 7 days to configure. It is
important to note that submissions entered via the new system will not be accepted before the
29th March. The MHRA has published two reference guides providing
step-by-step assistance on the processes required prior to gaining access to
MHRA submissions and managing user or administrator permissions.
Read MHRA Guidance in detail here www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
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