UK

Brexit: EMA’s regulatory guidance on centrally approved medicinal products – the present state of play

Jacqueline Bore

The champagne bottles have been drained in Amsterdam and tears dried in Milan and Bratislava but the serious work of mapping out the practical implications of Brexit continues at the European Medicines Agency (EMA). The EMA and the European Commission issued a Notice in May 2017 confirming that “unless the withdrawal agreement establishes another date” Read More

Pension funds to catalyse growth in Life Sciences companies?

Matthew Appleton

We’ve seen a lot of activity in the past week around how the UK government plans to galvanise growth in innovative companies (summary here). As I wrote a couple of months ago, only by focusing on all stages in the growth cycle of a Life Sciences company can four £20bn+ UK companies be created in Read More

Life Sciences M&A in a holding pattern

Matthew Appleton

Continued uncertainty surrounding President Trump’s proposed tax reforms has slowed activity in the Life Sciences sector, with deal values holding well below the record levels seen in previous years. If Trump’s promised corporate tax cut materialises, big U.S. players may be encouraged to repatriate (and spend) the huge amounts of cash currently held offshore.  But Read More

European and UK medical device industry bodies urge post-Brexit regulatory alignment

William Palmer

In a joint letter to the negotiators representing the UK and EU, medical device and in vitro diagnostic industry trade groups have urged both parties to ensure full regulatory implementation in their sector following “Brexit”, in March 2019.  The trade groups represented are MedTech Europe (MedTech), the Association of British Healthcare Industries (ABHI) and the Read More

The definition of “product” in the SPC Regulation: (Part 1 of 2) What’s in a name?

Nicola Dagg

Anyone familiar with supplementary protection certificate (SPC) law will know the importance of the definition of “product” for SPC purposes. “Product” is defined within art.1(b) of Regulation (EC) No 469/2009 (the SPC Regulation) and plays a central role in the interpretation of that Regulation, in particular as regards the conditions for obtaining an SPC set Read More