Join our webinar on Thursday, 20 January 2022 for an engaging discussion on trade compliance, customs laws and risks of sanctions within the cannabis industry. Our panel of legal experts in international trade compliance will discuss such topics as: what the cannabis industry can do to be more trade compliant, how to navigate the multi-jurisdictional variances in customs laws, how to reduce the risks associated with the import and export of cannabis and how to identify and mitigate sanctions risks.
On 31 August 2021 the European Commission launched a consultation on the operation of Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities targeted at stakeholders involved in such activities.
The Heads of Medicine Agency has published a letter highlighting its plans to collaborate with other European medicines agencies to build knowledge on the approaches taken by member states with a record of effective, consistent trial reporting, with a view to sharing guidance with all member states as to “best practice” clinical trial reporting ahead of the new Clinical Trial Regulation and enhanced transparency rules coming into force. This article sets out the reasoning behind the letter’s publication, as well as an overview of key provisions within the CTR.
On 15 June 2021, after an initial consensus from health ministers in Luxembourg, the European Parliament’s health committee approved an extension of the European Medicines Agency’s (EMA) mandate.
On 22 June, UK International Trade Secretary Liz Truss began negotiations with Yasutoshi Nishimura, the current chair of the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP).
In brief The 2021 APBI Code was approved by ABPI members at a special General Meeting on Tuesday 12 January 2021 and it will come into operation on 1 July 2021. The changes to the 2021 ABPI Code were primarily made to reflect the structure of the 2019 EFPIA Code…
In brief As previously discussed in our article on Brexit-related challenges for the life sciences sector dated 12 February 2021, batch testing was omitted from the Trade and Cooperation Agreement (TCA) signed by the UK and EU on 30 December 2020. Whilst the EU is yet to grant recognition of…
In brief In response to the Conservative Party’s manifesto promise, both industry and government have agreed to make production of new drugs to patients as attractive and innovation-embracing as possible. This, coupled with MHRA emerging from under the European Medicines Agency to function as a wholly independent body, presents an…
The Canada-United Kingdom Trade Continuity Agreement (Canada-UK TCA) replicates the Canada-European Union Comprehensive Economic and Trade Agreement (CETA) on a bilateral basis. The Canada-UK TCA (signed December 2020) came into force from 1 January 2021 and aims to maintain the status quo in the trade relationship.
Following four and a half years of often acrimonious negotiations and numerous build ups to a no-deal situation, the EU-UK TCA represents a positive step. While the deal is relatively thin and offers only discrete regulatory reciprocity, overall the TCA is a welcome development in the face of apparent near- political failure to agree on a way forward between the two sides. The life sciences sector has been preparing for no-deal amidst the global coronavirus (COVID-19) pandemic, throughout 2020, and having a deal, however slim, is positive for the sector in providing more fertile political ground for future harmonisation and cooperation