Herbal medicines and Dietary supplements
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1 Herbal medicines and Dietary supplements
2 Herbal Products Herbal medicine Traditional herbal medicinal product Ph.Eur.: Plant drugs, species plant-based dietary supplements plant-based food products, certain teas
3 Herbal medicine It contains one or more herbal material(s) or extract(s) or their combination. Well-established use category National Institute of Pharmacy authorizes them. This type of application may be submitted if the applicant can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Community for at least ten years, with recognized efficacy and an acceptable level of safety.
4 Traditional herbal medicinal product (= THMPD) From Decree of the Minister of Health No. 52/2005 (XI. 18.), Directive 2004/24/EC They are herbal medicines, which - are administered orally, externally, or by inhalation - are intended to be used without supervision by a medical doctor - The intended use of herbal medicines will only be authorized on the basis of its traditional history and/or the recognized pharmacological properties of the herbal ingredient(s). - Vitamins and minerals may be added to the herbal medicine provided that their use is ancillary to the herbal ingredient(s)
5 Traditional herbal medicinal products Attributing a preventive or curative effect to these products is allowed. They contain one or more herbal substances, preparations or their combination as active agents. They can be distributed in pharmacies. Their authorization is possible via abridged registration. Need to demonstrate that the herbal medicine has been in use within the EU for at least 30 years or 15 years within the EU, and 30 years outside the EU.
6 Requalification of herbal products Those herbal products, which contain only herbal components or herbal component, can be in the market until their date of expiry, but not later than 1 April, Requalification is possible: - to herbal medicine or traditional herbal medicine (product) - to dietary supplement
7 Herbal tea (species) Is a herbal or plant infusion and usually not made from the leaves of the tea bush (Camellia sinensis). Typically, herbal tea is simply the combination of boiling water and dried fruits, flowers or herbs.
8 Dietary supplement Is a preparation intended to supplement the diet and provide nutrients, such as vitamins, minerals, fiber, fatty acids, or amino acids, that may be missing or may not be consumed in sufficient quantities in a person's diet. Some countries define dietary supplements as foods, while in others they are defined as drugs or natural health products. Supplements containing vitamins or dietary minerals are included as a category of food in the Codex Alimentarius, a collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to foods, food production and food safety. Decree of 37/2004. (IV.26.) ESZCSM Approx
9 What is not a dietary supplement? Herbal tea Traditional herbal medicinal products Special foods for the athletes Formulas which substitute breast milk Medicinal nutrition
10 The Oxford Center for Evidence-Based Medicine Hierarchy Randomized controlled trials 1. Cohort studies 2. Case-control studies 3. Case series / Case study 4. Anecdotal evidence 5. Level of Evidence a. Systematic review of RCTs b. Individual RCTs c. All-or-none studies a. Systematic review of RCTs b. Individual cohort studies c. Outcomes research a. Systematic reviews of casecontrol studies b. Individual case-control studies a. Includes poorly designed cohort and case-control studies a. Animal research b. Bench research c. Unpublished clinical observations Oxford Center for Evidence-Based Medicine--Levels of Evidence (March 2009)
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