Last week’s round -up;
18-22 January 2021
Canada-UK Trade Continuity Agreement
As of the 1st January 2021, the Canada-EU Comprehensive Economic and Trade Agreement (CETA) no longer applies to the United Kingdom. However, Canada and the UK have agreed on an interim Canada-United Kingdom Trade Continuity Agreement (Canada-UK TCA) until a comprehensive free trade agreement is in place. Until the agreement officially enters into force, Health Canada, the MHRA and the VMD have agreed on an interim arrangement for continued cooperation on the application of the CETA Protocol on pharmaceuticals in order to avoid any disruption in trade. Canada and the UK will continue to recognise GMP certificates issued by each country’s regulatory agencies and to accept batch testing certificates held by a manufacturer without re-control of that batch at import.
Brexit Trade Deal
The Brexit trade deal contains certain provisions concerning the pharmaceutical and biotech industries that allow for smoother trade between the UK and EU. However, since the two parties now function as separate legal and regulatory jurisdictions, pharma and biotech companies will face additional barriers that did not exist prior to Brexit. The deal does ensure some intellectual property protections and commits the two parties to adhere to international standards. It also allows for mutual recognition of inspections and GMP documents between the UK and EU member states, with some conditions. The agreement allows the EU and UK regulators to request official GMP documents from each other, committing to provide requested documents within 30 calendar days. The agreement also reserves the rights of each party to conduct inspections of facilities that have been certified compliant by the other party. However, the other party must be notified prior to the inspection to allow for its participation during the inspection.
More information with regards to how the Brexit trade deal affects the pharmaceutical and medical device industries is available at the following RAPs article: http://bit.ly/RealCMC-2XSIdzk