The Life Sciences Law Review — France
Medicines and medical devices are regulated mainly under the Public Health Code (CSP), which deals with a wide array of matters such as clinical trials, marketing authorisations and CE-marking, manufacturing and distribution, advertising, and relationships with health-care professionals. The Social Security Code (CSS) also contains several provisions focusing on pricing and reimbursement.
This legal framework is complemented by a variety of governmental decrees and decisions of the health authorities, as well as agreements between authorities and representatives of the industry (e.g., for reimbursement).
The main authorities involved in enforcing the medicines and medical device regulations are as described below.
The National Security Agency of Medicines and Health Products (ANSM) has a wide role that includes inter alia the following topics:
- clinical trial authorisations;
- marketing authorisations and pharmacovigilance and materiovigilance;
- analysing the risk-benefit balance of health products during their life cycle;
- authorisation and monitoring of pharmaceutical establishments; and
- advertising of medicines and medical devices…
If you are registered and logged in to the site, click on the link below to read the rest of the Hogan Lovells briefing. If not, please register or sign in with your details below.
News from Hogan Lovells
News from The Lawyer
Briefings from Hogan Lovells
With increasing internet penetration throughout the country, the e-commerce industry, like other industries in China, is growing at a swift pace.
A tribunal decision that required a committed Christian to work on a Sunday on an occasional basis in accordance with her contract of employment did not discriminate against her.
Analysis from The Lawyer
The Lawyer’s latest Top 50 litigation firms list shows that business for dispute specialists is roaring along while new in-depth detail reveals the winning strategies
The Russian legal market faces a new era as the government opens the door to greater business transparency, but not everything is open to scrutiny