Supplementary declaration 5 - Application for registration – homeopathic medicinal product
DECLARATION OF CONTROL OF HOMEOPATHIC STOCK
2.1 Scientific name of the homeopathic stock
State the scientific name according to Ph. Eur. or International Nonproprietary names (INN);
Substances of chemical and mineral origin: scientific name in English.
Substances og herbal origin: scientific latin name and part of plant used.
Substances of animal origin: scientific latin name and part of organism used.
2.2 Justification of the homeopathic use □ Enclosure no.
2.3 Manufacturing method according to official pharmacopoeia. State pharmacopoeia and method (e.g. HAB1,
2000, 2a).
2.4 Manufacturer of homeopathic stock. State company
2.5 Quality standards Specifications should normally include: Identity (e.g. macroscopic and microscopic
examination, thin-layer chromatography, melting point), purity (e.g. sulphate ash, foreign constituents, loss
on drying, microbiological purity) and content/assay)
All approved batches of the homeopathic stock fulfill:
a) The quality requirements according to a monograph in a pharmacopoeia
State the pharmacopoeia used (e.g. Ph. Eur. current edition or HAB current edition):
b) Quality requirements according to in-house monography.
□ Enclosure no.
c) Microbiological requirements. State limits and method
2.6 Shelf-life of the homeopathic stock
2.7 Responsible for Quality Control. State company
I declare that the above stated information is accurate and complete and is consistent with the actual
conditions.
Date
Qualified Person/Quality responsible
Company
Name in block letters
Signature
The documentation this declaration is based on (e.g. batch records, certificates of analysis) is available for
inspection by the authorities. at the following site:
Registration holder/representative/manufacturer responsible for batch release
Specifications and certificate for analysis should be attached unless this declaration is signed by the manufacturer
responsible for batch release
If the raw material is based on animal/microbiological material this declaration should be accompanied by
complete documentation for the tests listed above.
Supplementary declaration 5 - Application for registration – homeopathic medicinal product
DECLARATION OF CONTROL OF HOMEOPATHIC STOCK
Manufacturer of homeopathic stock/mother tincture
Address
P.O. Box
City or town
Country