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Biological medicinal products substitution in France?
Biological medicinal products are used in the treatment of numerous pathologies, such as diabetes, cancer and autoimmune diseases. Any biological medicinal product whose patent has
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How to open a pharmaceutical establishment in France?
In France, the Public Health Code (PHC) defines different status: Status Authorised activities Manufacturer Manufacture of medicinal products, products or objects referred to in Article
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TITLE: The Jardé Law and Research Involving Human Subjects (RIPH): How Are Pharmaceutical Companies Affected?
Medical research is essential for the development of new treatments and the improvement of healthcare. In France, this research is governed by strict regulations designed
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The Excellence of ATESSIA’s CMC: Your Partner in Technical and Regulatory Affairs
In a constantly evolving pharmaceutical industrial environment, regulatory requirements for quality data are becoming increasingly complex. Health authorities are continually updating guidelines, increasing CMC demands
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The Post-Approval Change Management Protocol or “PACMP”
In Europe, changes to a marketing authorisation (MA) for a human medicine are covered by Regulation (EC) No. 1234/2008 of November 24, 2008. This regulation
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What are Good Manufacturing Practices (GMP) ?
Definition Good Manufacturing Practices are a set of principles and guidelines. The first GMPs were published in France in 1978. These guidelines are regularly updated
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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
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What is the European Pharmacopeia ?
This article deals with the essential information you need to know about the European Pharmacopoeia (whose official acronym is “Ph. Eur.”), a unique reference work
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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