PDF《(THR 20894/0071)》

4 INTRODUCTION The MHRA granted Traditional Herbal Registration Certificates for the traditional herbal medicinal products Max Strength Milk Thistle Tablets (THR 20894/0071) and Milk Thistle Tablets (THR 20894/0072) to Brunel Healthcare Manufacturing Limited on

14 March 2012. These products are on the general sales list (GSL). These applications were submitted according to Article 16.c of Directive 2001/83 EC, as amended, as part of the Traditional Herbal Medicines Registration Scheme. The products are used to relieve the symptoms associated with occasional over indulgence of food and drink, such as indigestion and upset stomach, based on traditional use only. The data supplied by the applicant demonstrate

30 years of traditional use of Milk thistle fruit in the EU. A satisfactory review of the available safety data on Milk thistle fruit has also been provided, together with an Expert Safety Report supporting the proposed products. MHRA PAR;

GERARD HOUSE MAX STRENGTH MILK THISTLE TABLETS (THR 20894/0071) AND GERARD HOUSE MILK THISTLE TABLETS, HERBALSTORE MILK THISTLE TABLETS AND WILKO MILK THISTLE TABLETS (THR 20894/0072)

5 PHARMACEUTICAL ASSESSMENT HERBAL SUBSTANCE: MILK THISTLE FRUIT Latin name of plant: Silybum marianum (L.) Gaertner Common name of plant: Milk thistle Plant family: Asteraceae The Milk thistle fruit used in this product are grown in Europe and are harvested during July and August. Confirmation has been provided that the herbal substance is produced in line with the Guideline on Good Agricultural and Collection Practice (GACP) EMEA/HMPC/246816/2005 and that the herbal substance has not been fumigated or treated with ionizing radiation during growing or storage. Control of Herbal Substance An appropriate specification based on the Ph Eur monograph is applied and is acceptable. The specification is supported by the batch data provided. Container Closure System Satisfactory details of the container closure system are provided and confirmation has been given that all components of the container closure system comply with current legislation relating to plastic materials and articles intended to come into contact with foodstuffs. Stability Satisfactory stability studies have been carried out on the Milk thistle fruit. HERBAL PREPARATION: MILK THISTLE FRUIT DRY EXTRACT Drug extract ratio: 20-40:1 Extraction solvent: Ethyl acetate

100 % v/v Manufacture A satisfactory description of the manufacturing process of the herbal preparation and flow diagram have been provided. The in-process controls are satisfactorily detailed. The manufacture of the herbal preparation is considered a standard procedure. Certificates of Analysis for all materials used in the manufacture of the herbal preparation have been provided. Control of Herbal Preparation A satisfactory specification with appropriate tests and limits has been provided for the herbal preparation. Satisfactory analytical procedures are used to control the quality of the herbal preparation. Analytical procedures have been validated, as appropriate. MHRA PAR;

GERARD HOUSE MAX STRENGTH MILK THISTLE TABLETS (THR 20894/0071) AND GERARD HOUSE MILK THISTLE TABLETS, HERBALSTORE MILK THISTLE TABLETS AND WILKO MILK THISTLE TABLETS (THR 20894/0072)

6 Certificates of Analysis have been provided for production batches of the herbal preparation, demonstrating satisfactory compliance with the proposed specification. Container Closure System Confirmation is provided that all components of the container closure system used to store the herbal preparation comply with current legislation relating to plastic materials and articles intended to come into contact with foodstuffs. Stability Stability studies have been performed in accordance with current guidelines. The proposed re-test period for the Milk thistle fruit dry extract is acceptable. HERBAL PRODUCTS: MAX STRENGTH MILK THISTLE TABLETS MILK THISTLE TABLETS Description and Composition of the Herbal Products Max Strength Milk Thistle Tablets are pale yellow caplet shaped film coated tablets and Milk Thistle Tablets are yellow circular biconvex film coated tablets. Max Strength Milk Thistle Tablets contain