France

Simplification of registration procedure for French person responsible for pharmacovigilance

Eveline Van Keymeulen

In February 2020, the French National Agency for Medicines and Health Products Safety (ANSM) announced that it had set up a new portal on its website, accessible from 1 March 2020, allowing the electronic registration of persons responsible for pharmacovigilance (RPVs) in France. The registration was previously carried out through email or post. Under Article Read More

On-going debate on new French Bill regarding online sale of medicines

Eveline Van Keymeulen

On 5 February 2020, the French government introduced a wide-ranging Bill to the Senate, entitled “the acceleration and simplification of public action”, which deals with a variety of matters, including new provisions on e-commerce for medicinal products (Article 34). Currently, the online sale of medicines is highly regulated in France: only medicinal products that can Read More

French ANSM establishes accelerated procedures for Covid-19 treatments and issues FAQ for on-going clinical trials

Eveline Van Keymeulen

The French National Agency for Medicines and Health Products Safety (ANSM) recently announced the set-up of accelerated procedures for the assessment of Covid-19 treatments that are currently being developed.  However, no further details regarding this accelerated procedure are publicly available. In the context of the pandemic, clinical trials for other treatments taking place in French Read More

French Administrative Supreme Court annuls CEPS decision for market exclusivity reasons

Eveline Van Keymeulen

On 5 February 2020, the French Administrative Supreme Court (Conseil d’Etat) annulled a decision from the Economic Committee for Health Products (CEPS) from 15 March 2018, considering that it negated the useful effect of the regulation applicable to orphan medicines. Under Article 8 of the Orphan Medicinal Products Regulation ((EC) No 141/2000), a manufacturer who Read More

France takes concrete actions to ensure continued supply and good use of health products in the context of Covid-19

Jeanne Fabre

In the context of Covid-19, the French government took some immediate actions to ensure the supply and price limits of healthcare products (such as masks and hydro-alcoholic products) to healthcare professionals and health facilities in need and to ensure the good use of some medicinal products (see our previous blog post: “EU takes measures to Read More