Farmacopea Alemana 2023

Content
The German Pharmacopoeia (DAB) is part of the pharmacopoeia according to § 55 of the German Medicines Act (AMG). It only contains rules at national level, which are therefore not included in the European Pharmacopoeia (Ph. Eur.).

The DAB 2022 will enter into force on 1 October 2022. The printed edition is a loose-leaf work with supplementary deliveries published once a year.

Content: General part:
Preface, Introduction, General Instructions for the Use of the Pharmacopoeia, Descriptions of General Test Methods and Reagents
Special Part: Monographs with definitions, test methods and storage and labelling requirements

The Pharmacopoeia consists of three parts: The German Pharmacopoeia (DAB), the European Pharmacopoeia (Ph. Eur.) and the Homeopathic Pharmacopoeia (HAB). It aims to check the quality of medicines to ensure safe use. It establishes unified, common rules applicable to the national pharmacopoeias HAB and DAB in Germany, for the Ph. Eur. in the European area.

According to the German Medicines Act, the pharmacopoeia is a “collection of recognised pharmaceutical rules on the quality, testing, storage, dispensing and designation of medicinal products and the substances used in their manufacture” published by the Federal Institute for Drugs and Medical Devices (BfArM) in agreement with the Paul-Ehrlich-Institut (PEI) and the Federal Office of Consumer Protection and Food Safety (BVL). (§ 55 AMG). It also contains rules for the nature of containers and wrappings.
The recognized pharmaceutical rules described in monographs and other texts of the pharmacopoeia correspond to the current state of scientific knowledge.