8.3.1 Processed plant materials may be supplied as ingredients to practitioners or as starting materials to product manufacturers. In these cases, the following information should be supplied:

(a) taxonomical classification of the plant including genus, species and family;

(b) common names;

(c) expected countries of origin;

(d) part of the plant used and its condition (such as fresh aerial part; dried root and rhizome, sliced or decorticated);

(e) year, season, preliminary preparation and drying and methods of collection, if necessary;

(f) the method of preparation, including details of new processing techniques; and

(g) the excipients used (where relevant) for commercial reasons.

8.3.2 Where, for commercial reasons, the supplier/manufacturer of processed medicinal materials does not wish to provide details of the extraction methodology or excipients used to the manufacturer or practitioner, a notification (listing) or registration procedure could be implemented. In this case, particularly if using new processing methods, in addition to the information required under 8.3.1, the following information, may also be required, if relevant:

(h) characterizing compounds of the processed medicinal material and the chromatogram of the characterizing compounds;

(i) data on long-term toxicity tests, if appropriate;

(j) data on mutagenicity tests;

(k) data on carcinogenicity tests, if appropriate;

(k) data on reproductive and developmental toxicity tests when necessary;

(l) stability tests;

(m) quality standard, including the assay or limit of toxic ingredients, microorganisms, mycotoxins, heavy metals and pesticide, insecticide and herbicide residues; and

(n) reports on clinical trials, when necessary.