Requirements for manufacturing

Europäisches Arzneimittelbuch

Legislative standards

The legislative standards according to which we manufacture are set forth in the Europäischen Arzneibuch (Pharm Eur.) (the European Pharmacopoeia) as well as in the German Homöopathisches Arzneibuch (HAB) (the German Homeopathic Pharmacopeia). 

 

Besides Germany, only France and India have a national homeopathic pharmacopeia. The harmonization between the regulations of the German and French homeopathic pharmacopeia and the resulting integration into the European Pharmacopoeia is a continual process.

 

Legally, homeopathic remedies can be marketed only when manufactured according to the regulations of all three of the above mentioned pharmacopeias.

Paragraph 38 Pharmaceutical Law: Registration of homeopathic remedies

The following general rules apply: Homeopathic remedies can only be marketed when appropriately registered with the higher federal authority (Bundesoberbehörde).

 

Exceptions to this rule: Homeopathic remedies of vegetable or mineral/chemical origin of which less than 1,000 units are sold annually.

 

Remedies of animal origin: Homeopathic remedies of animal origins always have to be registered.

 

Nosodes: Always have to be registered.


How is a remedy registered in Germany?
In Germany, a remedy is registered by submitting an application for registration to the Federal Institute for drugs and medical devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM)

 

Examination of raw materials: Analysis for the presence or absence of  pesticides, heavy metals, aflatoxins.  Examination for identity, quantitative analysis, absence of microorganisms and other pathogenic organisms, validation of viruses in case of starting materials of animal origins. 

 

The legislative standards apply to all starting materials and do not pertain to the finished LM-potency. Subsequently, the finished remedy has to be analyzed. 

 

Laboratory analysis of auxiliary products: Identity and purity


Control of the finished remedy: Stability, shelf life after opening, microbiological examination according to the European Pharmacopoeia.