France

ANSM clarifies that it does not recommend “neutral packaging” of medicinal products in the midst of pharma industry criticism

Eveline Van Keymeulen

Yesterday, the French National Agency for Medicines and Health Products Safety (ANSM) provided some clarifications with respect to its Recommendations for applicants and holders of marketing authorisations on the labelling and packaging of human medicinal products dispensed in solid oral form and its Recommendations on the choice of medicinal product names (dated February 2018) (see our Read More

French implementing rules on safety features and anti-tampering device adopted

Eveline Van Keymeulen

On 23 April 2018, Decree No. 2018-291 relating to safety within the medicinal supply chain entered into force. The decree follows a February 2018 information note from the Ministry of Health reminding retail pharmacists and healthcare institutions of their obligations under Commission Delegated Regulation (EU) 2016/161, which further implements the requirement of Directive 2011/62/EU that Read More

France publishes list of low-interventional and non-interventional human clinical trials

Eveline Van Keymeulen

On 18 April 2018, two orders further detailing the rules on non-interventional and low-interventional trials in France entered into force. The first order replaces a May 2017 Order that established a list of interventions allowed in low-interventional trials (see our previous blog post, France further clarifies scope of clinical trial rules). Low-interventional trials are trials Read More

French Administrative Supreme Court paves way for advertising non-prescription medicines on pharmacy websites

Eveline Van Keymeulen

In its decision dated 4 April 2018, the French Administrative Supreme Court annulled the November 2016 Order regarding technical rules applicable to websites selling medicines (see our previous post: Online sales of medicines take a step forward in France) insofar as the order prohibits advertising of over-the-counter (OTC) medicines on pharmacy websites. The court ruled Read More

French IPO allows extension of the duration of SPCs on the basis of the MA notification date

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