Pharmacy is the umbrella term for the science concerned with the development, production, quality assurance, mechanisms of action, and use of medicinal products. It also includes patient counseling, proper storage, and the controlled dispensing of medications according to defined quality standards.
The pharmacopoeia is a body of legislation and contains recognised pharmaceutical rules on the quality, testing, storage, dispensing and designation of medicinal products and the substances used in their manufacture. This information is collected and updated in pharmacopoeias according to standardised criteria in various countries and states - for example in the European Pharmacopoeia (Ph.Eur) and the German Homoeopathic Pharmacopoeia (GHP or Homöopathisches Arzneibuch - HAB). The Pharmacopoeia is the primary source for all quality standards and test methods for drugs and excipients (BfArM - Arzneibuch, n.d.)
Pharmacopoeias are the reference works for pharmacies, pharmaceutical manufacturers and quality control authorities to ensure that medicinal drugs fulfil certain quality requirements. They contain general regulations, descriptions of defined test methods, explanations of reagents, buffer solutions and excipients, manufacturing techniques, as well as monographs (see there) for individual active ingredients and drugs with detailed information on composition, purity, efficacy and test methods.
The monograph[1] is generally defined as a comprehensive, complete treatise on a single subject, a single work or a specific problem.
The drug monograph is divided into several sections according to the requirements of the pharmacopoeia
General guidelines for the preparation of drug monographs follow a fixed scheme (Robert & Zündorf, 2019) :
1. Name of the drug
2. Qualitative and quantitative composition
3. Dosage form
4. Clinical information
4.1 Areas of application
4.2 Dosage and method of application
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interactions with other drugs and other interactions
4.6 Fertility, pregnancy and breastfeeding
4.7 Effects on the ability to drive and use machines
4.8 Side effects
4.9 Overdosing
5. Description of the pharmacological properties
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. Pharmaceutical information
7. Date of creation and last
Every pharmaceutically used substance must fulfil the requirements of the pharmacopoeia monograph. For homeopathic remedies, these are laid down in homeopathic pharmacopoeias, e.g. in the German Homeopathic Pharmacopoeia - GHP. (see there)
The Homeopathic Pharmacopoeia (German homeopathic Pharmacopeia - GHP or Homöopathisches Arzneibuch - HAB), is like the German Pharmacopoeia (Deutsches Arzneibuch - DAB) and the Austrian Pharmacopoeia (ÖAB), part of the pharmacopoeia. The HAB has also been legally valid in Austria since 1984. The HAB, ÖAB and DAB supplement the European pharmacopoeia (Pharmacopoeia Europaea, Ph. Eur.) - with those national rules that relate to specific areas of application or additional test procedures that are not contained in the Ph. Eur.
The GHP defines the rules on drug quality, manufacturing and testing procedures and, in accordance with the German Act for drugs (Arzneimittelgesetz - AMG § 55 ; Act on the Trade in pharmaceutic drugs), forms the guidelines to be applied by pharmaceutic drug manufacturers within its area of application. It contains the drug monographs (see there).
Commission D (Komission D) is an independently operating expert commission at the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM) in Germany. In accordance with the requirements of the German Act for drugs AMG § 25 para. 6, Commission D works as an interdisciplinary team for the specialist area consisting of several experts, including doctors with additional qualifications in homeopathy, alternative practitioners, experts in pharmacology and pharmacy as well as patient representatives. The members of Commission D are newly appointed every three years.
Its task is to advise the BfArM on the authorization (registration) of homeopathic drugs for human medicine, in particular on issues relating to the use of homeopathic drugs in children and adolescents. (BfArM - Komission D, n.d.)
After the AMG came into force in 1978, the Commission D was set up at the Federal Health Office (Bundesgesundheitsamt BGA), which was responsible at the time, to analyze and evaluate the pharmaceutical market at the time and to compile monographs as part of the subsequent approval of active substances used in homeopathy.
Similarly, Commission C was appointed for phytotherapeutics and Commission E for anthroposophic drugs.
In 1994, the fifth amendment to the AMG put an end to the reprocessing process. Since then, the monographs compiled by Commission D have served as the basis for the new authorization of homeopathic drugs.
In 2004, improvements were made to drug safety in the AMG.
Due to the decline in the therapeutically necessary variety of homeopathic medicines observed since the turn of the millennium, the User Alliance for the Preservation of Homeopathic Medicines (Anwenderbündnis für den Erhalt der Homöopathie - AEHA) was founded in 2006 in Germany by the three professional organizations DZVhÄ, BKHD and VKHD as an interest group for the preservation of homeopathic medicines.
The lack of availability of therapeutically irreplaceable homeopathic medicines is a consequence of European and national legislation, which, often due to ignorance or indifference, fails to adequately account for the specific characteristics of homeopathy as a therapeutic approach and the role of homeopathic medicines. In particular, safety regulations for conventional pharmaceuticals are frequently indiscriminately applied to homeopathic remedies, leading to significantly higher costs for manufacturers. As a result, rarely requested, yet practically important individual remedies are phased out of the market due to insufficient profitability.
This process must be counteracted through sustained education and proactive contact with legislation. In addition, the AEHA supports compulsory pharmacy supply of homeopathic remedies as a necessary prerequisite for adequate quality assurance.
(Further information on the objectives and activities of the AEHA: http://www.aeha-buendnis.de/aeha-das-anwenderbuendnis-zum-erhalt-homoeopathischer-arzneimittel)
[1] Word origin: Greek mónos (μόνος) = alone, only and Greek -graphía (-γραφία) to gráphein (γράφειν) = to carve, draw, write
Authors: glt | Rev.: sfm, bga | Editor: pz | last modified Jule 7, 2025