An evaluation of western herbal complementary medicine labelling in South Africa, to determine whether the product labelling information complies with established herbal monographs and whether it meets local regulatory requirements

• Main Author: TYMBIOS, Joanna Antonia
• Other Authors: Van Huyssteen, Mea
• Language: en
• Published: University of the Western Cape 2016
• Subjects: Complementary Medicines (CMs); Medicines Control Council (MCC); European Medicines Agency (EMA); Labels; Western herbal medicine
• Online Access: http://hdl.handle.net/11394/5111

Magister Pharmaceuticae - MPharm === Medicines (CMs) are widely available to the South African public. However, CMs have not yet been evaluated by the Medicines Control Council (MCC). The MCC has published new guidelines for the regulation of CMs, with which CM companies are required to comply. OBJECTIVE: Determine to what degree Western Herbal CM labelling complies with the MCC’s requirements. METHODS: Thirteen CM products containing recognised Western Herbal ingredients were selected from pharmacies in the northern suburbs of Johannesburg. Labelling information on the immediate and outer container labels, as well as the package inserts, was investigated. The relevant corresponding European Medicines Agency (EMA) monographs and MCC guidelines were used to assess compliance. RESULTS: None of the products complied with the product dosage section of the monographs. Furthermore, the products contained indications that were not present in the monographs. The products did not fully meet the MCC’s mandatory minimum labelling requirements, and they did not demonstrate total compliance with all of the MCC’s requirements for product labels and package inserts.