Herbal medicinal products and traditional herbal medicinal products

Herbal medicinal products and traditional herbal medicinal products

Poster

Gyulfie Babalieva, Tsvetelina Galabarova, Maria Vasileva
Faculty of Chemistry and Pharmacy, Sofia University "St. Kliment Ohridski ", Bulgaria

"Herbal medicinal product" means a medicinal product which contains as a substance one or more herbal substances or one or more herbal preparations or one or more herbal substances in combination with one or more herbal preparations. "Traditional herbal medicinal products" are those herbal medicinal products which have been used for at least 30 years, at least 15 years of which are within the EU, and which are intended for use without medical supervision by a medical practitioner and do not apply in the form of injections. Traditional herbal medicinal products must meet the following criteria: they should have characteristics which are characteristic of traditional herbal medicinal products which, by reason of their composition and use, have been designed and intended to be used without supervision by a medical practitioner for diagnosis, appointment or monitoring of treatment. They are intended to be prescribed according to the indicated concentration and dosage. These are preparations for oral, external use and / or inhalation. The data on the traditional use of the medicinal product are sufficient, in particular, the safety of the product under specified conditions of use and the pharmacological effects or efficacy of the medicinal product have been demonstrated due to the duration of use and the experience gained. For the issuance of a certificate for registration of a traditional herbal medicinal product, the person shall submit to BDA an application form, accompanied by a file in the format "Electronic General Technical Document" containing: name and address of management, name of the medicinal product, data on qualitative and quantitative composition, therapeutic indications, contraindications, adverse drug reactions, dosage, dosage form, route of administration and route of administration, shelf-life, precautions and precautions for product storage.
Key words: нerbal medicinal products, traditional herbal medicinal products