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