Guidelines for the Appropriate use of Herbal Medicines
(1998; 88 pages)
Table of Contents
View the documentForeword
Open this folder and view contents1. Introduction
Open this folder and view contents2. Goals and objectives of the guidelines
View the document3. Definitions
Open this folder and view contents4. National policy development
Open this folder and view contents5. Development of a national programme on herbal medicines
Open this folder and view contents6. Regulation of practitioners
Open this folder and view contents7. Regulation of the manufacture and distribution of medicinal herbal products
Close this folder8. Regulation of herbal medicines
View the document8.1 General considerations
View the document8.2 Requirements for raw plant materials
View the document8.3 Requirements for processed plant materials
View the document8.4 Requirements for medicinal herbal products
View the document8.5 Label requirements
View the document8.6 Responsible government agency for regulation
View the document8.7 Promotion and advertisement of herbal medicines
View the document8.8 Monitoring of adverse reactions to herbal medicines
View the document9. Use of the guidelines
View the documentAnnex 1: Report of the meeting of the working group on herbal medicines
View the documentAnnex 2: List of temporary advisers, consultants, observers and secretariat
View the documentAnnex 3: Agenda
View the documentAnnex 4: Opening Speech of Dr S.T. Han, WHO Regional Director for the Western Pacific Region Working Group on Herbal Medicines, 8 December 1997, Manila, Philippines
View the documentAnnex 5: Closing Remarks of Dr S.T. Han, WHO Regional Director for the Western Pacific Working Group on Herbal Medicines, 12 December 1997, Manila, Philippines
View the documentReferences
 

8.3 Requirements for processed plant materials

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.

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