The Law Sciences Law Review - .PDF file.
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…
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