In detail
Legal basis
The basis is the Convention of 22 July 1964 on the Elaboration of a European Pharmacopoeia, a partial agreement of the Council of Europe. Germany acceded to it by federal law in 1973. Under Section 55 of the German Medicinal Products Act (AMG), the pharmacopoeia is a collection of recognised pharmaceutical rules published by the Federal Institute for Drugs and Medical Devices (BfArM) in agreement with the Paul-Ehrlich-Institut and the Federal Office of Consumer Protection and Food Safety (BVL). It comprises the European, German (DAB) and Homoeopathic (HAB) pharmacopoeias. DAB and HAB only contain rules not covered by the European Pharmacopoeia.
Structure
- General part: general notices, test methods, reagents and general texts.
- Specific part: individual monographs on active substances, excipients or preparations, family monographs and general monographs, for example on dosage forms.
How binding is it?
Under Section 55(8) AMG, only substances and containers that comply with recognised pharmaceutical rules may be used in the manufacture of medicines. According to BfArM, the general notices and the monographs are binding in principle. Test methods and other general texts only become binding when a monograph cites them. The implementation date is set by the Council of Europe's Public Health Committee. It is published in English and French, the official languages of the Council of Europe. Germany, Austria and Switzerland produce the German translation jointly. In Germany, Austria and Switzerland, the European Pharmacopoeia only becomes binding on those subject to it once the joint German translation is available, which BfArM announces in the Federal Gazette.
Role in marketing authorisation
Under Directive 2001/83/EC, the rules of the European Pharmacopoeia apply in the authorisation procedure. Where it contains no rule, the pharmacopoeia of an EU Member State may be used, and only after that the pharmacopoeias of third countries. For the testing of starting materials, this means that anyone testing a substance against a different monograph should be able to justify this in the marketing authorisation dossier.
In practice at A&O Pharma
Our GMP-certified laboratory in Itzehoe tests starting materials to Ph. Eur. or to an alternative monograph. This also includes release testing and EU retesting of medicinal products.
Analytical ServicesFrequently asked questions
Is the European Pharmacopoeia legally binding in Germany?
Yes. It is part of the pharmacopoeia under Section 55 AMG and becomes binding through the operating regulations under Section 54 AMG. The German version applies from the date BfArM announces in the Federal Gazette.
What is the difference between the Ph. Eur. and the DAB?
The German Pharmacopoeia (DAB) only contains national rules not included in the European Pharmacopoeia. Rules of the European Pharmacopoeia replace national rules.
Are the general test methods of the Ph. Eur. always binding?
No. According to BfArM, test methods and other general texts only become binding when a monograph cites them. On their own, they have the status of guidance.
