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As Novel Coronavirus (COVID-19) continues to spread across the globe, in an effort to prepare for all eventualities, on 10 February 2020, the UK Government passed into law The Health Protection (Coronavirus) ...
The new, fifth edition of Internet Law & Regulation is the long-awaited new edition of the leading title in its field. The title presents an analysis of key areas of internet law & regulation from a UK perspective. ...
It has been clear for some time now that the European Medicines Agency (EMA), based in Canary Wharf, London since its establishment in 1995, will be relocated to another EU Member State as a result of the UK’s ...
The Chambers & Partners Pharmaceutical Advertising Global Practice Guide 2018 is now available online. The UK chapter has been written by Bird & Bird’s Sally Shorthose and Sarah Faircliffe,
The EU’s regulatory framework for orphan drugs is set out in Regulation (EC) No.141/2000 (the “Orphan Drug Regulation”, or ODR) and implementing Regulation (EC) No. 847/2000, and has been in force for a while now ...
In October 2016, the final report on the Accelerated Access Review (AAR) of innovative medicines and medical technologies was published, putting forward a series of recommendations on how to speed up access to ...
In our newsletter of November 2015, we discussed ongoing litigation in Germany and France concerning the liability of Notified Bodies under the Medical Device Directive following the Poly Implant Prothèse ("PIP”) ...
On 15 September 2015, the General Court delivered its judgment in Case T-472/12, Novartis Europharm v European Commission (supported by Teva). Novartis was challenging a marketing authorisation (MA) granted to Teva ...
Referred to by various terms (staggered approval, managed entry, progressive authorisation), “adaptive licensing” is a departure from the traditional approach to authorising new medicinal products.
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