Agnieszka Zimmermann, Lubomira Wengler, Rafał Zimmermann

Status prawny Farmakopei

Legal status of Pharmacopeia
The aim of the article is to present the position of Pharmacopoeia from the point of view of its legal status as well as its use in pharmaceutical practice. On the basis of the system of the legal sources sanctioned by the Constitution of the Republic of Poland a thesis may be advanced that Pharmacopoeias, and European Pharmacopoeia or Polish Pharmacopoeia, in particular, do not constitute a universally binding source of law. Pharmacopoeias, however, have a certain legal dimension, in particular, due to the fact that they are issued on the basis of normative acts, which constitute a source of law in the light of the Constitution of the Republic of Poland, as well as due to the numerous references to their contents in legal acts.
Keywords: Pharmacopeia, legislation.