Pharmacopoeia Europaea (Ph. Eur.)

In the European Pharmacopoeia, under the heading "Purpose of the Pharmacopoeia" is the following statement: "The pharmacopoeia is responsible for the health of the population with the help of promoting recognised, joint rules, which are to be observed and noted by all persons concerned with the quality of medicines. These rules must be of suitable quality so as to ensure the safe use of medicines for patients and consumers. "The Pharmacopoeia therefore defines the quality parameters of all drugs independently of whether they are of a chemical-synthetic, herbal or animal nature. It also states the methods used to check the quality of the drugs. The quality control refers to the identity of the substance (question: is the substance really identical with the label on the packaging), the purity of the substances (question: do the impurities lie below a tolerable concentration) and on the content (question: does the drug really contain a defined minimum amount of active ingredient). Only after these tests prove positive, may the ingredient or the drug be traded as drugs or processed into a drug. The quality requirements are logged in the pharmacopoeia in the form of substance or drug monographs. The European Pharmacopoeia, currently the 6th edition with the corresponding addenda is valid and has the force of law in all countries of the European Union and Switzerland. It facilitates the free exchange of medicinal products in Europe and guarantees the quality of exported drugs from Europe. The European pharmacopoeia is being developed in the framework of the Council of Europe in Strasbourg and is the responsibility of the European Pharmacopoeia Commission consisting of competent national delegations. Three addenda are issued every year to reflect the latest research on quality and quality control reasonably quickly.

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