Following the recent agreement to delay Brexit until 31 January 2020, the UK Department of Health and Social Care ("DHSC") has written to suppliers of UK medicines and medical devices to confirm the continued contingency...more
11/8/2019
/ Border Security ,
Contingency Plans ,
Cross-Border Transactions ,
Customs ,
EU ,
Imports ,
Medical Devices ,
Member State ,
No-Deal Brexit ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Procurement Policies ,
Regulatory Requirements ,
Strategic Planning ,
Supply Chain ,
UK Brexit ,
Withdrawal Agreement
The Queen's Speech, which set out the government's proposed plan for new legislation, included a new "Medicines and Medical Devices Bill". The government's background briefing describes the purpose of the Bill as ensuring...more
With the possibility of the UK leaving the EU on 29 March 2019 (a "no deal" Brexit) still on the table, life sciences companies are continuing their "no deal" preparations....more
3/21/2019
/ EU ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Member State ,
No-Deal Brexit ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Standards ,
UK ,
UK Brexit
Do you hold a CE certificate of conformity issued by a UK notified body? Are your manufacturing activities, authorised representative, suppliers, customers or contracting parties located in the UK?
...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance on how the UK would regulate medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019...more
1/7/2019
/ Clinical Trials ,
EU ,
Generic Drugs ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Member State ,
No-Deal Brexit ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Standards ,
UK ,
UK Brexit
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has initiated a consultation on the legislation and regulatory processes for medicines, medical devices and related clinical trials that would need to be...more
10/5/2018
/ Consultation ,
EU ,
European Medicines Agency (EMA) ,
Imports ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Member State ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agencies ,
Regulatory Oversight ,
UK ,
UK Brexit
On 23 August 2018, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of the National Competent Authorities in the European Economic Area (EEA), published the work programme of their...more
9/6/2018
/ Biotechnology ,
EU ,
European Economic Area (EEA) ,
European Medicines Agency (EMA) ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Standards ,
Supply Chain ,
UK ,
UK Brexit ,
Veterinary Products
The UK government has published several guidance documents on how to prepare for Brexit in the event of a "no deal" scenario (i.e. if the UK and EU do not agree a future trade deal and the proposed post-Brexit...more
The White Paper appears largely positive for the life sciences industry, incorporating many of the key asks from the industry across its priority areas of regulation, trade, people and innovation....more
The UK Government has published a response to the recommendations set out in the Health and Social Care Committee’s Report dated 21 March 2018 on “Brexit: medicines, medical devices and substance of human origin”, which...more
The UK Government has published a response to the recommendations set out in the Health and Social Care Committee’s Report dated 21 March 2018 on “Brexit...more
The UK House of Commons Health and Social Care Committee has published the findings of its six-month long investigation into the impact of Brexit on medicines, medical devices and substances of human origin. ...more
3/28/2018
/ Biosimilars ,
Biotechnology ,
EU ,
European Medicines Agency (EMA) ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Member State ,
Pharmaceutical Industry ,
Referendums ,
Regulatory Oversight ,
UK ,
UK Brexit
The UK government has published a White Paper setting out its new Industrial Strategy and, as part of that strategy, has agreed a Sector Deal with the UK life sciences sector. ...more
On the same day as the European Council voted to move the European Medicines Agency (EMA) from London to Amsterdam, the UK Parliament issued a briefing paper on Brexit and medicines regulation. ...more
11/22/2017
/ EU ,
European Medicines Agency (EMA) ,
Imports ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Member State ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Referendums ,
Regulatory Agencies ,
Regulatory Oversight ,
UK ,
UK Brexit
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on taking human factors into account when designing medical devices and ensuring that they meet the essential safety and performance...more
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published an interactive guide to assist companies with understanding the requirements of the new EU Medical Device Regulation (“MDR”) and In Vitro...more
Life sciences companies in both the EU and the UK are beginning to speculate on what Brexit will mean for business. In this video, Elisabethann Wright, partner, and Jane Summerfield, counsel, in our European Life Sciences...more