Pharmaceuticals
Can the Italian healthcare system process sensitive personal data without explicit patient consent?
18 April 2018 - Posted by: Emilio De Giorgi
On 27 March 2018, a draft of the legislative decree (Draft Decree) that is expected to replace the Italian Privacy Code following the entry into force of the EU General Data Protection Regulation (GDPR) was published. The Draft Decree anticipates important novelties regarding the way in which medical facilities will have to handle the processing › Read More
11 April 2018 - Posted by: 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
09 April 2018 - Posted by: 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
04 April 2018 - Posted by: 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
French IPO allows extension of the duration of SPCs on the basis of the MA notification date
01 April 2018 - Posted by: Laëtitia Bénard
The French Intellectual Property Office (IPO) recently issued a notice (French language) advising that the expiration date of French supplementary protection certificates (SPC) can be extended upon request of the registered SPC holder. The notice applies the 2015 Seattle Genetics ruling of the European Court of Justice (ECJ) which held that the relevant date for the › Read More