Every medicinal product for human use that is to be placed on the European Community market must be granted a marketing authorisation delivered by a competent authority. Marketing authorization herbal medicinal products is done in Poland according to national law and Ministry of Health regulations.

Quality is the basis of reproducible efficacy and safety of the medicinal products.

The quality of herbal medicinal products is determined by the quality of the starting plant material, adherence to Good Agriculture and Collection Practice, product development, in-process controls (e.g. raw material testing, in-process testing, stability testing, etc), Good Manufacturing Practice controls, by validated manufacturing process and by specifications applied to them throughout development and manufacturing.

Control strategy for herbal substance, herbal preparation and herbal medicinal product include testing of identification, purity and impurities (microbial levels, aflatoxins, heavy metals, pesticides, and fumigants), content of the active substances or markers determination, profile and stability data.

The rigorous standardization is defined as content of a constituent or a group of substances with known therapeutic activity or markers of the herbal substances and herbal medicinal products. It is a necessary step for the industry in order to prepared the registration dossier, validate preclinical and clinical data to register the product as a medical product and control its quality after marketing authorization during the shelf. The proper level of standardization is possible to attain by using the combination of different analytical techniques (GC, HPLC) for the known compounds or for the unknown components.

The general quality aspects of medicinal products cover European Pharmacopoeia, Polish Pharmacopoeia and CPMP-ICH, CPMP guidelines (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and Committee for Proprietary Medicinal Products).

The particularly guidelines of herbal medicinal products are provided by HMPC guidelines of the Committee for Herbal Medicinal Products being part of the European Medicines Agency (EMEA), body of the European Union with headquarters in London.

The format of chemical, pharmaceutical and biological documentation of a registration application and list of references to quality guidelines for herbal medicinal product is defined in:

The Rules governing Medicinal Product in the European Community:

The Notice to Applicants Volume 2B, CTD-Module 2.3 Quality Overall Summary-herbal and Module3 Quality-herbal, edition July 2003.

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