European Pharmacopeia

The European Pharmacopeia , worked out by DEQM (European Direction of the Quality of the Drug & the Health care), is an institution of the the Council of Europe. Its seat is with Strasbourg. Founded in 1964 by the Relative convention with the development of the European Pharmacopeia , it is coming into effect at the same time as this one in 1974.

The purpose of it is the development of a common Pharmacopée, replacing its national equivalents, and allowing a better circulation of the drugs between its members, while guaranteeing their quality better.

The European Pharmacopeia is a reference essential in the evaluation of the relative data with quality in the national and European AM files of the drugs to which always refer the revised directives (directives 2001/82/CE and 2004/28/CE for the drugs of veterinary use and directives 2001/83/CE, 2003/63/CE and 2004/27/CE for the drugs of human use). It is the scientific tool of standardization and public health with an opposable legal authenticity whose non-observance is sanctionnable by the legal authorities.

The standards of the European Pharmacopeia apply to all the drugs whatever their origin (chemical, biological or containing plants), their mode of production (drugs resulting from biotechnologies or genetic engineering) or their type: homeopathic, original or generic drugs, vaccines, etc Its fields of intervention are extremely broad and relate to the active ingredients as well as the excipients, even the containers, etc It comprises more than 2.000 monographs on preparations and substances and nearly 300 general methods of analysis and 2.400 reagents.

It counts 36 members today, as well as the observant European Union and 19 countries and WHO.

External bonds

Site of the European Pharmacopeia (EDQM)
Europe of the drug

Source

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