Supplementary declaration 4 - Application for registration – homeopathic medicinal product
DECLARATION OF CONTROL OF RAW MATERIALS
1.1 Scientific name of the raw material
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.
1.2 Country of origin. (Must be stated for biological material.)
1.2.1
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 raw material fulfill:
a) 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
d) For herbal material which is used for products with dilution D4 or D5 maximum limits for pesticides, heavy
metals and mycotoxins should be stated. In case these impurities are not controlled this should be justified
1.3 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, test records, certificates of analysis) is
available for inspection by the authorities at the following site upon request from the Norwegian Medicines
Agency:
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 4 - Application for registration – homeopathic medicinal product
DECLARATION OF CONTROL OF RAW MATERIALS
Source/Manufacturer(s) of raw material
Name of the source/manufacturer
Address
P.O. Box
City or town
Country