arcoro Glossar

Pharmacopoeia

The Pharmacopoeia is subject to the German Medicines Act. It consists of three parts: the German part, the European part and the Homeopathic part. While the European Pharmacopoeia mainly contains regulations on medical fields that require a uniform standard and guideline, the German part contains additional national regulations on the quality, control and storage of medicinal products. Furthermore, it regulates the dispensing and terminology of preparations as well as the condition of packaging and containers.

All three parts consist of a general part and monographs. In the general part, various pharmaceutical analytical procedures are presented. The monographs contain definitions, testing processes, and storage guidelines for chemicals and drugs. Drugs that are newly included or continue to be listed after an efficacy check are referred to as positive monographs. However, if drugs are removed from the pharmacopoeia by the relevant commissions due to their insufficient curative effect, they are referred to as negative monographs. The monographs are prepared according to the specifications of the regulatory authorities, quality control officers and drug manufacturers. The background and purpose of the European and German Pharmacopoeia is to improve human health through recognized, unified standards and regulations regarding drug quality.

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