Homeopathic Medicinal Products

1. How is a homeopathic medicinal product defined?

Homeopathic medicinal products are prepared from homeopathic stocks according to specific homeopathic manufacturing procedures. These procedures are defined in the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in a member state of the European Economic Area.

2. Where is the difference between an authorised and a registered homeopathic medicinal product?

In case of a national marketing authorisation evidence on the specific homeopathic efficacy has to be provided either by clinical trials or generally accepted bibliographic data (e.g. Monographs of the Commission D of the former BGA in Germany). The therapeutic indication for a homeopathic medicinal product is granted in accordance with the above mentioned submitted documentation.

In case of a registered homeopathic medicinal product no specific therapeutic indication appears in the name, on the labelling or in the package leaflet. The homeopathic use of the stock must be justified on the basis of adequate bibliographic data (see HMPWG document “Points to consider on the justification of homeopathic use of the stock”). The safety of the medicinal product has to be guaranteed by a sufficient degree of dilution of the active substance(s). Registered homeopathic medicinal products are only administered orally or externally.

3. What application form has to be used for a (national) application for marketing authorisation of a homeopathic medicinal product?

Information about the transmission of documents see guide L_Z45_Leitfaden_zur_Elektronischen_Einreichverordnung_EEVO.

4. What application form has to be used for a (national) application for registration of a homeopathic medicinal product?

Information about the transmission of documents see guide L_Z45_Leitfaden_zur_Elektronischen_Einreichverordnung_EEVO.

5. Is there any regulatory guidance available for homeopathic medicinal products?

At the European level the Homeopathic Medicinal Products Working Group (HMPWG) of the Heads of Agencies (HMA, www.hma.eu/human.html) strives towards harmonisation. Helpful guidance is available on the website of the HMA-HMPWG: http//www.hma.eu/79.html

6. What guidance is available with regard to safety of homeopathic medicinal products?

On the website of the HMA-HMPWG the following documents are available:

  • “Points to consider on non-clinical safety of homeopathic medicinal products of botanical, mineral and chemical origin”
  • “Points to consider on safety of homeopathic Medicinal Products from Biological origin”

7. What are the requirements on the quality of homeopathic medicinal products?

The content of the dossier has to follow the Annex I of Dir 2001/83/EC as amended and the note for guidance of the HMPWG “Guidance on module 3”.

8. Are data from stability testing necessary for homeopathic medicinal products?

Active substance:
According to the "Points to consider on Stability Testing of HMPs" of the HMPWG two options are acceptable:

a) stability testing of the homeopathic stock according to the guideline on stability testing CPMP/QWP/122/02; or

b) testing of the homeopathic stock for compliance with the specification immediately before further processing. According to the Annex I of Dir. 2001/83/EC as amended stability data obtained from homeopathic stocks are generally transferable to dilutions/triturations obtained thereof. The shelf life of the dilutions/triturations must not exceed the shelf life of the homeopathic stock.

Finished product:
Stability tests should generally include all tests defined in the European Pharmacopoeia for the respective dosage form. Additionally physical parameters (e.g. content of ethanol, relative density) should be tested.
Substance-related stability tests (e.g. as chromatographic fingerprint) may be omitted only if it can be demonstrated that due to the high degree of dilution the concentration of the active substance is below the limit of detection of the analytical method.

9. Are MRP/DCP possible for homeopathic medicinal products?

European procedures may be used in case of registered homeopathic medicinal products.

For authorised homeopathic medicinal products the same criteria apply as for other authorised medicinal products. When planning MRP/DCP attention should be paid to possible special national provisions for the marketing authorisation of homeopathic medicinal products. If the application refers to such special national provision European procedures cannot be used.

10. Pyrrolizidine alkaloids (PA): What limits do apply for PA if a medicinal product contains a plant which biosynthesises PA?

Following the national decree according to §5 of the Austrian Medicines Law from 1.8.1994 medicinal products which contain parts or constituents of plants of the genus Cynoglossum, Petasites, Senecio, Symphytum or the species Eupatorium cannabinum or Tussilago farfara must not be placed on the market unless it can be demonstrated by means of a state-of-the-art analytical method that the finished product does not contain PA.
From this ban homoeopathic medicinal products are exempted if they contain potency ≥ D6 for oral use or potency ≥ D4 for cutaneous use. The potency refers to the final concentration in the finished product.
In the light of the fact that pyrrolizidine alkaloids have been detected in herbal substances and preparations from plants, which do not typically biosynthesize these compounds a revision of the national decree according to §5 of the Austrian Medicines Law is considered.

11. Pyrrolizidine alkaloids (PA): Is it mandatory to test also homoeopathic preparations derived from plants mentioned above?

In principle yes.
Please see the Nr. 16 FAQs on Herbal Medicinal Products for the list of plants and herbal preparations for which a testing is mandatory and the testing scheme.
However, herbal preparations in homoeopathic medicinal products are exempted if they contain a potency ≥ D6 for oral use or a potency ≥ D4 for cutaneous use.

A testing of preparations in lower potencies may be waived in case of low posologies. A calculated assessment of the risk may be sufficient. For such calculations a worst-case scenario has to be applied (highest published contamination in herbal drugs: 3430 µg/kg, assumption of a complete extraction).

Created: 29.08.2013 | Page last modified: 22.03.2016

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