Europska regulativa biljnih i tradicionalnih biljnih lijekova

Professional paper - Professional paper

• Author: Darko Trumbetić
• Author: Ivan Kosalec
• Author's institution: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of microbiology)
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract (english)

Medicinal products, which contain only herbal substances or
herbal preparations as active ingredients, can be approved, in
line with European legislation, and legislation of Republic of Croatia, as herbal
medicines after marketing authorization procedure, or as traditional herbal medicines
after simplified registration procedure.
Differences between the above stated categories of herbal and traditional
herbal medicinal products are often unknown to health professionals and patients.
It is important to point out specific differences upon which marketing authorization far herbal medicines or registration of traditional herbal medicine is granted.
The application documentation far herbal and traditional herbal medicinal
products, as well as its assessment, are quite complex. Each product which is
intended to be placed on the market in medicinal product category must fulfill
all applicable requirements according to regulations in Republic of Croatia and
European Union in the field of medicinal products, in order to ensure its quality,
efficacy and safe use.
Also, it is important to encourage health professionals to inform patients
that there are other categories of products besides the medicinal products, such
as medical devices, cosmetics and food supplements, which may contain similar
or same herbal substances. Since medicinal products are subject to the most
rigorous requirements, which ensure the best quality, it is important to distinguish
them from other categories of products.

• Keywords (croatian): biljni lijekovi; tradicionalni biljni lijekovi; interakcije lijekova; nuspojave lijekova; regulativa lijekova
• Language: croatian
• Publication type: Professional paper - Professional paper
• Publication status: Published
• Peer review: Peer review - domestic
• Publication version: Published version
• Journal title: Farmaceutski glasnik
• Numbering: vol. 75, no. 3, pp. 207-218
• p-ISSN: 0014-8202
• URN:NBN: urn:nbn:hr:163:841329
• Publication: 2019
• Type of resource: Text
• Access conditions: Open access
• Created on: 2020-06-08 08:00:57