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What are CEPs ?
CEP : what’s that? In Europe, three distinct possibilities exist for presenting information relating to the active substance, from a qualified manufacturer, used in a medicinal
What is the European Pharmacopeia ?
European Pharmacopoeia : what’s that? This article deals with the essential information you need to know about the European Pharmacopoeia (whose official acronym is “Ph. Eur.”),
What future for therapeutic cannabis in France?
A bit of history In September 2018, a multidisciplinary scientific committee made up of ANSM, healthcare professionals and patients was set up to review scientific
Poisonous Substances: What Use within the Pharmaceutical Industry?
Poisonous substances are defined in French legislation (and only in this legislation!) and include certain substances classified as dangerous according to categories defined by the
Therapeutic patient education versus learning programs: what is role for the pharmaceutical industry?
> Definition and content Therapeutic patient education (TPE) can be defined in several ways. The World Health Organization (WHO) gave the following definition in 1996:
What is the Requirement for Transparency of Conflicts of Interest with Healthcare Professionals in France?
Following the “Médiator” case and inspired by the Sunshine Act in the United States, the law of December 29, 2011, concerning the strengthening of health
What are the mechanisms for early and compassionate access in France?
Atessia supports its clients daily in the practical modalities of implementing the French early and compassionate access system, whose subtleties require some explanations. On July
What are the differences between the Mutual Recognition Procedure and the Decentralized Procedure ?
From a legislative point of view, the mutual recognition procedure is defined by the Directive 2001/83/EC of the European Parliament and of the Council of
What about the classification of Marketing Authorization variations?
What about the classification of Marketing Authorization variations? When a holder wishes to register a medicine in a country, he submits a marketing authorization application