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On 1 October 2006 the following two EMEA HMPC Guidelines are supposed to
become effective:
1. CPMP/QWP/2820/00 Rev.1
Guideline on specifications: test procedures and acceptance criteria
for herbal substances, herbal preparations and herbal medicinal
products/traditional herbal medicinal products
This Guideline describes the general principles for determining and
justifying uniform specifications for herbal starting materials and herbal
medicinal products. The complete document is available here.
2. CPMP/QWP/2819/00 Rev.1
Guideline on quality of herbal medicinal products/traditional herbal
medicinal products
The important items of this guideline are:
- Qualitative and quantitative particulars of the active substance(s)
of a herbal medicinal product
- Description of the method of preparation of the herbal medicinal
product
- Control of starting materials
- Control tests on herbal medicinal products
- Stability Tests
This guideline is available here.
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