News & Analysis as of

Manufacturers Pharmaceutical Industry France

Hogan Lovells

Nouvelle contrainte à la charge de l’industrie pharmaceutique dans la lutte contre les pénuries de médicaments

Hogan Lovells on

Un nouveau dispositif, porté par le projet de loi de financement de la sécurité sociale pour 2024, pourrait aboutir à imposer aux entreprises exploitant un médicament mature d’intérêt thérapeutique majeur qui souhaiterait en...more

Hogan Lovells

New offensive against the pharmaceutical industry in the fight against medicinal product shortages

Hogan Lovells on

A new draft measure, included in the Social Security Financing Bill for 2024, aims to require companies operating a mature medicinal product of major therapeutic interest (MITM) that wishes to suspend or cease marketing it,...more

McDermott Will & Emery

Intellectual Property & Health: Need to Know - France & Europe - February 2022

McDermott Will & Emery on

UNIFIED PATENT COURT - The Unified Patent Court (UPC) should become a reality in 2022 or in the first few months of 2023. The Protocol on Provisional Application (PPA) of the Agreement on a Unified Patent Court (AUPC)...more

Hogan Lovells

The French "safeguard clause for medical devices” – a critical assessment

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Since 2017, the French financial regulation applicable to medical devices is gradually moving closer to the regulation governing pharmaceutical products. ...more

Jones Day

French Court Clarifies Surveillance Obligations

Jones Day on

The Situation: In a recent decision, the French Supreme Court clarified the surveillance obligations of notified bodies—independent entities accredited by an EU Member State's national health authority to determine whether a...more

Jones Day

France Simplifies Local Medical Device Regulations and Sets Precedent for Other Member States

Jones Day on

On April 26, 2018, the French administrative Supreme Court (Conseil d'Etat) issued a ruling that annulled Decree 2016-1716 of December 13, 2016 ("2016 Decree") related to the summary of characteristics for medical devices....more

Jones Day

French ANSM Clarifies Guidance Related to Raw Materials for Pharmaceutical Use

Jones Day on

On January 31, 2017, the French National Drug and Health Product Agency ("ANSM") issued an updated FAQ related to the authorization and declaration procedures of manufacturing, import, and distribution of raw materials for...more

Hogan Lovells

International Product Liability Review - Issue 65

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The International Product Liability Review provides quality updates and comment from around the world on legal developments in the field of product liability and product safety. ...more

Hogan Lovells

France imposes an extra notification obligation on Class III and implantable medical devices manufacturers

Hogan Lovells on

On 13 December 2016, the French Decree 2016-1716[1] implementing the French Law 2016-41 modernising the French healthcare system[2] (“French Law 2016-41”) was adopted. This Decree provides important information concerning the...more

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