Regulatory & compliance

General Court explains the concept of environmental law in the Aarhus Convention and annuls Commission decision on products containing genetically modified soybeans

Tine Carmeliet

On 14 March 2018, the European General Court (General Court) ruled that non-governmental organisations (NGOs) have the right to request that the European Commission (Commission) review a decision that authorises the placing of genetically modified food and feed on the market. The background to this judgment relates to a Commission’s 2015 decision in which the Read More

Rise of New CRISPR Inventions: the toolbox of research applications for CRISPR-based systems continues to expand

Daniel Lim

Although much of the reporting around CRISPR tends to focus on its cleavage based ability to knock out or repair targeted sequences of DNA in a genome, some of the most exciting developments in the CRISPR field do not involve gene editing at all. Many of these advances are already being put into effect in Read More

Belgian regulator amends guidelines on labelling and packaging of human medicines

Tine Carmeliet

On 1 March 2018, the Federal Agency for Medicines and Health Products (FAMHP) published amended guidelines on the labelling of medicines within the context of new marketing authorisations, renewals or variations for medicines for human use.  Pharmaceutical companies should comply with these guidelines, which stipulate specific requirements for the packaging and labelling of medicines. The Read More

Revised Dutch policy rules on inducement prohibition regarding medicinal products enter into force

Iradj Nazaryar

On 1 April 2018, revised policy rules concerning the inducements prohibition with regard to medicines (“Beleidsregels Gunstbetoon Gnw 2018“) entered into force. These policy rules provide guidance on what qualifies as an “inducement” and the scope of the prohibition. The new policy rules revise the previous version dating back to 1 May 2014 in light Read More

Getting ready for the EU MDR: Classification of medical devices

Eveline Van Keymeulen

In this second post of our “Getting ready for the MDR” series, we look at how the MDR will affect manufacturers in classifying their devices according to the newly introduced rules and classification criteria. Rules on medical device classification will not radically change under the upcoming regulatory system, which will apply as of 26 May Read More