SMARTRISK – risk assessment excipient tool
The transition phase, during which EU legislation on social law coordination and the recognition of professional qualifications generally still applies, will last until the end of 2020. As the UK effectively remains within the EU’s Single Market and the customs union during this time, there will also be no changes to the movement of medicinal products and medical devices until the end of 2020.
Medicinal products and medical devices, which were legally placed on the market before the end of the transition phase, will retain the right to be traded in the markets of the EU and the UK after the transition phase until they reach their end consumers, without requiring product changes or renewed labelling.
Only 4 months left guaranteeing patients uninterrupted supply of their current treatments and fast access to new medicines and medical devices
The UK government updated its guidance on 3 August 2020 around what providers and commissioners of healthcare services can do to prepare for the end of Brexit transition on 1 January 2021, including links to the new UK Border Operating Model released on 13 July that could impact the supply of medical products.
UK and EU negotiators met again w/c 17 August for a further round of discussions on the future relationship.
On 1 September MHRA published numerous guidance documents which reflects the UK being fully independent making regulatory decisions for both medicinal products and medical devices after the transition period.
This guidance is focused on import and exporting, clinical trials, medical devices, licensing, pediatrics, and pharmacovigilance.
As long as there is no longer-term post transition Brexit agreement in place, companies must plan for the worst-case situation by preparing for a ”no deal” scenario whereby the EU and the UK fully diverge with respect to medicines regulation and the healthcare sector no longer benefits from concerted approaches under a European medicines regulatory network.
Under the terms of the Northern Ireland Protocol, from 1 January 2021, the rules for placing regulated products on the Northern Ireland market will differ from those applicable to Great Britain.
Considering regulatory timelines is now a must ensuring supply of healthcare products!
Importing and Exporting – update or amendments of manufacturing, import and wholesaler licenses are of utmost importance to ensure supply of regulated products. The responsibilities for batch-release, but also import and export of medicinal products and medical devices, should therefore now be determined and notified to the authorities. The corresponding QMS and regulatory systems need to be adapted accordingly in order to maintain supply of products in accordance with current and future regulations.
Clinical trials – substantial amendment and notifications requires 30 to 90 days for approval by the regulators – failing authorities’ approval may lead to suspension of the clinical trial. From 1 January 2021 substantial amendments and notifications become mandatory for registration of EU/EEA legal representative where sponsors are outside the EU/UK or to change (add/replace) any IMP manufacturing, importation or certification site relevant for supply of IMP.
Medical Devices – Depending on the risk class of a medical device or an in vitro medical device, manufacturers must work together with a Notified Body when pursuing the conformity assessment of their device. During the transition phase, British Notified Bodies are able, in principle, to continue to issue certificates for medical devices and in vitro diagnostic medical devices. Manufacturers concerned should be aware that there is currently no guarantee that UK Notified Bodies will continue to be authorised to operate following expiry of the transition phase and should verify contingency arrangements with their notified body for issue of conformity assessments following the end of the transition phase.
From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system and the most recent guidance gives further details on the timing for registration with the MHRA and the new UKCA conformity mark Within the UK the European CE Marking will remain valid until 30 Jun 2023, however the new UKCA mark will be mandatory for all devices after that date.
Pharmaceutical Licensing (pre and post-approval procedures) – ongoing EU approval procedures must finalize before end of the transition phase. National license process must be initiated by the UK-based and EU-based future Marketing Authorisation Holder separately. Marketing Authoristion Holders are obliged to consider applicable timelines for post-approval activities; in particular, 30- and 90-days procedures for standard and complex variations and renewals.
A wholesale dealer in Great Britain (excluding NI) from 01 Jan 2021 may import Qualified Person (QP) certified medicines from the European Economic Area (EEA) if certain checks are made by the Responsible Person (import) (RPi). In the absence of any likely mutual recognition deal however for UK manufactured products each batch must have a full quantitative analysis carried out in the EEA and must be certified by a Qualified Person within the EEA.
Paediatrics – no urgent action required since the scientific content and assessment performed by MHRA post-transition period will be kept in line with EU guidance documents on paediatrics.
Hence, authority interaction, document preparation and timely submission becomes critical.
If you have any questions relating to your new compliance requirement as a result of Brexit, our Technical Helpdesk service offers you fast, flexible technical support options. Contact us today: brexitsupport@pharmalex.com
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