Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 118

The products in the scope are drugs, blood-derived medicines, narcotic & psychotropic agents, vaccines, homoeopathic compounds, herbal medicines, customized preparations, biologicals (organs or tissues used as medicines, cell- gene-therapies, blood products) medical devices (therapy, in vivo or in vitro diagnosis, medical softwares), cosmetics and tattoo agents, biocides.

Even if many decisions are now taken at the EMA level, each EU local agency can make its own decision as long as it does not dispute the EU measures. These measures can lead to decisions in the French public health interest such as: Drug registration approval, withdrawal or suspension; Clinical Trials green light; Named patient basis use (individuals or cohort); Batch release for vaccines or blood-derived medicines; Batch/Product recall; Medical device ban; Import agreement; Advertising approval or refusal.

In line with the EU regulation updated in 2010/2012, the ANSM improved information for patients, healthcare professionals, media and increased transparency and close collaboration with other healthcare organizations (regional healthcare agencies, health insurance, other food and healthcare agencies, scientific societies) and patients/consumers.