Products

Dutch guidance on inducements by medical devices companies published

Iradj Nazaryar

On 31 August 2017, the Dutch Ministry of Health published Policy Rules providing guidance on the ban on inducements, which was introduced by the amendment of the Dutch Medical Devices Act of 17 May 2017.  The amendment establishes a prohibition on inducements, whether in cash or in kind, offered by medical device suppliers to professionals Read More

BeNeLuxA collaboration moves forward with launch of e-platform and two additional pilot projects

Tine Carmeliet

On 6 September 2017, the website of the BeNeLuxA collaboration, beneluxa.org, was officially launched (see Belgian and Dutch government press releases).  The BeNeLuxA collaboration is an initiative between Belgium, the Netherlands, Luxembourg and Austria on pharmaceutical policy that aims to ensure sustainable and affordable access to innovative medicines (in particular, orphan drugs) by levelling the Read More

European Commission assesses bids for the relocation of the European Medicines Agency

Jacqueline Bore

On Saturday, the European Commission (EC) published its assessment of the bids by 19 Member States to host the European Medicines Agency (EMA) when it relocates from London in March 2019. As instructed by the Member States, the EC has been careful to avoid betraying any preference by producing a ranking or short list. The 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