Regulators in both established and maturing agencies are facing challenges in their effort to provide...
The UK Brexit secretary Dominic Raab has announced that even though the UK Government is still optimistic to explore the terms under which the UK could remain as part of the European Medicines Agency (EMA) after leaving the EU in March 2019, the possibility of no deal being reached should be considered and a contingency plan should be prepared that could take effect by 29 March 2019 to ensure that UK patients have a sufficient supply of essential medicines.
The proposals in the government’s contingency plan will be less demanding than that published by the EMA for UK manufactures required to market their products in Europe, but UK companies need to seriously consider their position now should they wish to retain their European sales.
The Medicines and Healthcare products Regulatory Agency (MHRA) has outlined that it will require the following information from European companies wishing to market product in the UK, which will need to be submitted via a web portal on the MHRA website:
• Application for a marketing authorisation (MA)
• Periodic safety update reports (PSUR)
• Paediatric investigation plans (PIP)
• Clinical trial application (CTA)
• Qualified person pharmacovigilance (QPPV) and pharmacovigilance master file (PSMF) notifications
• Individual case safety reports (ICSR) and subsequent transmission of anonymised single patient reports (ASPR)
• Summit devices registration
Should the transitional period between March 2019 and December 2020 not be agreed in the event of a no deal scenario the UK Government will seek an agreement that all companies wishing to supply the UK market would be required to comply with the following:
• Pharmaceutical companies will be allowed to continue UK batch release testing and qualified person certification in the UK, with this being recognised by the EU and vice versa
• MA holders and QPPVs will continue to be able to be based in the UK and access EU markets. There will be continued mutual recognition of manufacturing and distribution licences, as well as associated inspections such as good manufacturing practice (GMP)
• Firms based in the UK will be able to continue to apply for MAs via either the centralised or decentralised procedures
• For medical devices, CE marking will continue to be used and recognised for both the UK and EU markets, and UK-based industry will not require an authorised representative established in the EU. UK notified bodies will continue to conduct third-party conformity assessment in the UK and the results of these tests will continue to be used and recognised for both the UK and EU markets
The UK Government has also requested that all companies supplying the UK market establish a minimum of six weeks stock to avoid stock shortages due to possible distribution in distribution after Britain’s exit from the EU.
Horizon 2020 funding with a no Brexit deal
This notice provides information on the Horizon 2020 underwrite guarantee, the extension to the guarantee and how our plans to support UK research and innovation will work in practice. It is aimed at UK organisations, such as universities and businesses that are in receipt of Horizon 2020 funding or are bidding for such funding, as well as EU organisations that work with UK participants on Horizon 2020 projects
To allow PharmaConsult to provide you with custom-made solutions to your UK and European medicines distribution that avoid possible medicines supply issues that might result in shortages of medicines, make an enquiry using the form on this page.
This white paper identifies some of the socio-economic factors that are influencing growth in the...
The Brexit negotiations have taken a dramatic turn this week, with the British Government rejecting...
At the European Council of Ministers meeting in Sofia, Bulgaria, UK Prime Minister Theresa May...