This new EMA guidance document provides general principles on the setting and justification of a uniform set of specifications herbal substances and preparations. Since a simplified registration procedure was established for traditional herbal medicinal products for human use the quality medicinal products is independent of its traditional use. More specifically the addition of vitamins to herbal products need to comply with all the relevant legislation guidance.
This document is concerned with the specific definitions as a list of tests, references to analytical and biological procedures and appropriate acceptance criteria a number of limit ranges and other criteria have been as described and established.
excerpt from regulations
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This guidance document provides general principles on the setting and justification, to the extent possible, of a uniform set of specifications for herbal substances/preparations and herbal medicinal products to support applications for marketing authorisation or registration according to Directives 2001/82/EC and 2001/83/EC as amended. It should be read in conjunction with the ‘Guideline on quality of herbal medicinal products’ (EMA/CPMP/QWP/2819/00, EMA/CVMP/814/00, EMA/HMPC/201116/2005, as revised).
A simplified registration procedure was established for traditional herbal medicinal products for human use under Directive 2004/24/EC. The quality of a medicinal product is independent of its traditional use; therefore all general principles of quality also apply to traditional herbal medicinal products for human use. Traditional herbal medicinal products for human use may additionally contain vitamins or minerals. Concerning these products, this guideline describes specific aspects linked to mixtures of herbal substances/herbal preparations with vitamins and/or minerals. In addition, the quality, specifications and documentation for each vitamin and mineral have to comply with all relevant legislation and guidelines.
A specification is defined as a list of tests, references to analytical and biological procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a herbal substance/preparation or herbal medicinal product should conform to be considered acceptable for its intended use. “Conformance to specifications” means that the herbal substance/preparation or herbal medicinal product, when tested according to the listed analytical procedures, will meet the listed acceptance criteria. Specifications are legally binding quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities.
Specifications are one part of a total control strategy for the herbal substance/preparation and herbal medicinal product designed to ensure product quality and consistency. Other parts of this strategy include thorough product characterisation during development, upon which specifications are based, adherence to the ‘Guideline on Good Agricultural and Collection Practice (GACP)’ (EMEA/HMPC/246816/2005) and Good Manufacturing Practice (GMP), and a validated manufacturing process, e.g., raw material testing, in-process testing, stability testing, etc.
In the case of herbal medicinal products, specifications are generally applied to the herbal substance, to the herbal preparation and to the herbal medicinal product. Specifications are primarily intended to define the quality of the herbal substance/preparation and herbal medicinal product rather than to establish full characterisation, and should focus on those characteristics found to be useful in ensuring the safety and efficacy of the herbal substance/preparation and herbal medicinal product.
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