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This website informs about certain regulations in connection with the European, Homeopathic and German Pharmacopeia and the activities of the Pharmacopoeia unit.

The pharmacopoeias can be obtained from Deutscher Apotheker Verlag.

Europäisches Arzneibuch
DAB 2023, HAB 2023, Europäisches Arzneibuch Source: BfArM

Pharmacopoeia according to § 55 AMG

The pharmacopoeia consists of the European, German and Homeopathic Pharmacopoeia.

According to § 55 AMG the pharmacopoeia is a collection of recognized pharmaceutical requirements regarding the quality, testing, storage, dispensing and designation of medicinal products and the substances used in their manufacture. They are announced by the Federal Institute for Drugs and Medical Devices in agreement with the Paul Ehrlich Institute and the Federal Agency for Consumer Protection and Food Safety. The Pharmacopoeia also contains requirements regarding the nature of containers and outer packaging.

Purpose of the pharmacopoeia

The purpose of the pharmacopoeia was defined in an introduction to the European Pharmacopoeia as follows. This explanation applies in the figurative sense also to the German and the homeopathic pharmacopoeia.

“The purpose of the European Pharmacopoeia is to promote public health by the provision of recognised common standards for the quality of medicines and their components. As these standards ensure that medicines reaching the market are safe for use by patients, it is essential that they are appropriate. Their existence also facilitates the free movement of medicinal products in Europe and beyond.

European Pharmacopoeia monographs and other texts are designed to meet the needs of:

–regulatory authorities;

–those engaged in the quality control of medicinal products and their constituents;

–manufacturers of medicinal products and their individual components.

Globalisation gives rise to new challenges in terms of the quality of pharmaceutical substances and medicines. To respond to these challenges, the European Pharmacopoeia has extended its international outreach and works closely with all its stakeholders to produce quality standards appropriate for medicinal products developed in an increasingly global world.”

Legally binding character of the Pharmacopeia

The Pharmacop0eia has a legally binding character for pharmacies, wholesalers, pharmaceutical companies and veterinary home pharmacies.
It is used as an official reference to serve public health, and is part of the regulatory requirements for obtaining a Marketing Authorisation (MA) for a medicinal (human or veterinary) product.
The German Pharmacopoeia, the German-language version of the European Pharmacopoeia and the Homeopathic Pharmacopoeia are announced in the Federal Gazette ((Bundesanzeiger)) by the Federal Institute for Drugs and Medical Devices in agreement with the Paul Ehrlich Institute and the Federal Agency for Consumer Protection and Food Safety. This announcement states in particular the date from which the respective pharmacopoeia is mandatory.
In the case of the European Pharmacopoeia, the competent higher federal authority also announces the date (implementation date) set by the Public Health Committee of the Council of Europe, from which the European Pharmacopoeia is applicable in the member states of the Convention for the elaboration of a European Pharmacopoeia (Convention).
In some states, such as Germany, the European Pharmacopoeia must be translated into the national language before it becomes formally binding, which naturally prolongs the procedure. Germany, Austria and Switzerland are jointly responsible for a German translation so that a common translated European Pharmacopoeia is available in all three countries.

European Pharmacopoeia

The European Pharmacopoeia (Pharmacopoeia Europaea, Ph. Eur.) provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them. It is a published collection of monographs that describes both the individual and general quality standards for ingredients, dosage forms, and methods of analysis for medicines. These standards apply to medicines for both human and veterinary use.
It is used as an official reference to serve public health, and is part of the regulatory requirements for obtaining a Marketing Authorisation (MA) for a medicinal (human or veterinary) product. The quality standards of the European Pharmacopoeia apply throughout the entire life-cycle of a product, and become legally binding and mandatory on the same date in all thirty-eight (38) signatory states, which include all European Union member states.
The official languages of the Council of Europe are English and French. Therefore, the European Pharmacopoeia is published in these languages by the secretariat of the European Pharmacopoeia Commission.
Comments on the European Pharmacopoeia must be submitted in these languages. In Germany, Austria and Switzerland, the European Pharmacopoeia can only become binding once it has been translated into German. Therefore, these countries provide the translation of the European Pharmacopoeia into German. This leads to a common German-language version of the European Pharmacopoeia used in all three states.

German Pharmocopoeia

The German Pharmacopoeia is a part of the pharmacopoeia according to § 55 AMG. It only contains requirements that are not contained in the European Pharmacopoeia.
The requirements in the German Pharmacopoeia are intended to be national, but according to Directive 2001/83 consolidated version, Annex I EC they are also valid in other EU countries if the European Pharmacopoeia does not contain corresponding rules.
The purpose of the German Pharmacopoeia is congruent with the purpose of the European Pharmacopoeia. Just like the latter, it governs the quality parameters and quality control of drugs and herbal drugs. It contains monographs of drugs that only have a meaning in Germany and therefore are not or not yet covered in the European Pharmacopoeia. It is only binding in Germany and is updated annually (loose-leaf booklet).

Deutsches Homöopathisches Arzneibuch (HAB) - German Homeopathic Pharmacopoeia

The German Homeopathic Pharmacopoeia (HAB) is a part of the pharmacopoeia according to § 55 AMG. The HAB provides the legal framework for the manufacturing and quality assurance of homeopathic remedies, published by the German Health Ministry.
It only contains requirements that are not contained in the European Pharmacopoeia (Ph. Eur.), because requirements of the European Pharmacopoeia supersede national requirements. The requirements contained in the Homeopathic Pharmacopoeia are intended to be national, but according to Directive 75/318 EEC they are also valid in other EU countries if the European Pharmacopoeia does not contain corresponding rules.

Pharmacopoeia Commissions

The AMG § 55 specifies that the German, European and Homeopathic Pharmacopoeia Commission are the highest decision-making boards for the Pharmacopoeia.

The Commissions have equal rights and decide autonomously in their respective areas of responsibility.

Since European rules supersede national rules and the secretariat of the Office of the Pharmacopoeia Commissions coordinates the work of the German and Homeopathic Pharmacopoeia Commission, there is no overlap.

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