Regulatory & compliance

France: Covid-19 coronavirus: French High Health Authority approves salivary tests to complement nasopharyngeal tests in symptomatic people

Jeanne Fabre

On 18 September 2020, the French High Health Authority (HAS) issued a press release announcing that it had approved the use of virological tests (RT-PCR) on saliva samples. The advantage of these tests is that they make sampling easier, reduce the risk of contamination for healthcare personnel and are less unpleasant for patients (notably children, Read More

Covid-19 coronavirus: patent database observations

Lars Braams

As per 8 September 2020, 143 search results containing the words “Covid 19” in the title, claims or the abstract of a patent show up in the international patent database Espacenet. Over the past weeks, this number grows with about 15 new results each week. While the race for a vaccine covers the headlines around Read More

EU: Derogation for Covid-19 clinical trials of medicinal products containing or consisting of genetically modified organisms

Veerle Pissierssens

In the context of the Covid-19 coronavirus pandemic, the European Union has adopted a Regulation providing for a temporary exemption from European legislation on genetically modified organisms (Regulation (EU) 2020/1043 of the European Parliament and of the Council of 15 July 2020 on the conduct of clinical trials with and supply of medicinal products for Read More

Belgium – FAMHP supports e-PIL pilot project

Tine Carmeliet

On 17 August 2020, the Federal Agency for Medicines and Health Products (FAMHP) announced its support for the pilot project on electronic patient information leaflets, e-PIL, a project replacing the traditional paper package leaflet for certain medicines with electronic leaflets on trusted websites, which was initiated by the Belgian and Luxembourgian pharmaceutical industry in 2018. Read More

French anti-gift regulation is now complete!

Jeanne Fabre

The two long-awaited orders of the French anti-gift regulation were finally published on 14 August 2020 (see our previous blog post: Decree on French anti-gift regulation published): Order of 7 August 2020 setting the amounts from which an agreement provided for in Article L1453-8 of the Public Health Code and specifying the granting of benefits Read More