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homeopathic drug master file (hdmf)

Statutory requirements and guidelines


In analogy with the European Drug Master File procedure for active substances, use can also be made of a comparable procedure for homeopathic medicinal products, provided that certain conditions are met. However, the HDMF procedure may only be used if reference is made to a previously authorised dossier.
The following parts of the dossier must be included in the marketing authorisation application submitted by the future marketing authorisation holder:
  • Name and address of the manufacturer of the homeopathic stock
  • Definition of the raw material used
  • Method used to prepare the homeopathic stock, with reference to the official pharmacopoeia
  • Specifications of the raw material and the analytical methods used
  • Specifications of the homeopathic stock and the analytical methods used
  • Origin and purification or processing (if applicable) of the raw material (indicate how the material is purified/processed/stored)
  • Details of validation of the assay methods (methods described in an official pharmacopoeia do not require validation)
  • Potential impurities arising from the source, purification and degradation (routine testing for potential impurities must always be carried out, unless it can be justified that this is unnecessary)
  • Results of analysis of both the raw material and the homeopathic stock
  • Stability data for both the raw material and the homeopathic stock
  • A statement that no change will be made to the manufacturing procedure or the specifications without informing the applicant, who will then submit an application to vary the marketing authorisation

All product-specific information must obviously also be included in the dossier (particularly that relating to the finished product: information on the manufacturing process, specifications, analytical results and stability).

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