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A Practical Guide to Licensing Herbal Medicinal Products

A Practical Guide to Licensing Herbal Medicinal Products
Author: Thomas Brendler
Publisher:
Total Pages: 0
Release: 2009
Genre: Materia medica, Vegetable
ISBN: 9780853697848

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This publication seeks to Answer all questions most frequently asked by manufacturers and provides full guidance on license applications. The procedure for licensing herbal products in the UK and European Union is changing. The Traditional Herbal Medicinal Product Directive (THMPD) was implemented in the UK in 2005 and allows herbal products to be registered under medicines law. By 2011, every pharmaceutical company manufacturing herbal medicines that are sold in the UK and European Union must have obtained a market authorization. As a manufacturer of such products, you need to ask the following: what type of herbal products are you manufacturing?; would your product comply with the regulations?; are you required to register your herbal products?; what type of registration or license do you need?; what evidence and manufacturing data do you need to provide?; what are the packaging and leaflet requirements for your product?; and, most importantly: how do you apply for a license? It also provides full guidance on product registration, including step-by-step guidance on completing the application forms, information on to whom the forms should be submitted and what costs are involved. All the official legal guidelines and forms are included within the guide. This text is easy and practical to use, guiding you and your company through the initial decision-making process to registering your herbal products.


Phytopharmacy

Phytopharmacy
Author: Sarah E. Edwards
Publisher: John Wiley & Sons
Total Pages: 438
Release: 2015-04-27
Genre: Science
ISBN: 1118543564

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Healthcare professionals, including doctors, pharmacists and nurses, are often confronted with patients who use over-the-counter (OTC) herbal medicinal products and food supplements. While taking responsibility for one’s own health and treatment options is encouraged, many patients use these products based on limited (and sometimes inaccurate) information from non-scientific sources, such as the popular press and internet. There is a clear need to offer balanced, well-informed advice to patients, yet a number of studies have shown that, generally, conventionally trained health practitioners consider their knowledge about herbal medicinal products and supplements to be weak. Phytopharmacy fills this knowledge gap, and is intended for use by the busy pharmacist, nurse, or doctor, as well as the ‘expert patient’ and students of pharmacy and herbal medicine. It presents clear, practical and concise monographs on over a hundred popular herbal medicines and plant-based food supplements. Information provided in each monograph includes: • Indications • Summary and appraisal of clinical and pre-clinical evidence • Potential interactions • Contraindications • Possible adverse effects An overview of the current regulatory framework is also outlined, notably the EU Traditional Herbal Medicinal Products Directive. This stipulates that only licensed products or registered traditional herbal medicinal products (THRs), which have assured quality and safety, can now legally be sold OTC. Monographs are included of most of the major herbal ingredients found in THRs, and also some plant-based food supplements, which while not strictly medicines, may also have the potential to exert a physiological effect.


Herbal Medicines

Herbal Medicines
Author: Joanne Barnes
Publisher:
Total Pages: 552
Release: 2002
Genre: Gardening
ISBN:

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Skunk cabbage 438; Slippery elm 440; Squill 442, St. John's wort 444; Stone root 459; Tansy 460; Thyme 462; Uva-ursi 465; Valerian 468; Vervain 477; Wild carrot 479; Wild lettuce 482; Willow 484; Witch hazel 486; Yarrow 489; Yellow dock 492; Yucca 494; App. 1: Potential drug-herb interactions 497; App. 2: Laxative herbal ingredients 501; App. 3: Cardioactive herbal ingredients 501; App. 4: Diuretic herbal ingredients 502; App. 5: Hypotensive and hypertensive herbal ingredients 502; App. 6: Anticoagulant and coagulant herbal ingredients 503; App. 7: Hypolipidaemic and hyperlipidaemic herbal ingredients 503; App. 8: Sedative herbal ingredients 503; App. 9: Hypoglycaemic and hyperglycaemic herbal ingredients 504; App. 10: Hormonally active herbal ingredients 504; App. 11: Immunomodulating herbal ingredients 504; App. 12. Allergenic herbal ingredients 505; App. 13: Irritant herbal ingredients 505; App. 14: Herbal ingredients containing amines or alkaloids, or with sympathomimetic action 506; App. 15: Anti-inflammatory herbal ingredients 506; App. 16. Antispasmodic herbal ingredients 507; App. 17: Herbal ingredients containing coumarins 507; App. 18: Herbal ingredients containing flavonoids 507; App. 19: Herbal ingredients containing iridoids 507; App. 20: Herbal ingredients containing saponins 507; App. 21: Herbal ingredients containing tannins 507; App. 22: Herbal ingredients containing volatile oils 507; App. 23. Council of Europe. Categories for natural sources of flavouring (report N. 1 Strasbourg: Council of Europe, 2000) 508.


Herbal Medicine

Herbal Medicine
Author: Iris F. F. Benzie
Publisher: CRC Press
Total Pages: 500
Release: 2011-03-28
Genre: Health & Fitness
ISBN: 1439807167

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The global popularity of herbal supplements and the promise they hold in treating various disease states has caused an unprecedented interest in understanding the molecular basis of the biological activity of traditional remedies. Herbal Medicine: Biomolecular and Clinical Aspects focuses on presenting current scientific evidence of biomolecular ef


The H.E.R.B.A.L. Guide

The H.E.R.B.A.L. Guide
Author: Robert Alan Bonakdar
Publisher: Lippincott Williams & Wilkins
Total Pages: 456
Release: 2012-03-28
Genre: Medical
ISBN: 1451148089

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The H.E.R.B.A.L. Guide will greatly assist clinicians in counseling patients about use of herbal and dietary supplements and integrating these supplements into the comprehensive clinical management of common conditions. The opening section offers practical advice on the clinician-patient dialogue about supplements. Subsequent chapters discuss key issues regarding labeling, dosing, regulation, interactions and reactions, efficacy, clinical trials, and the role of each member of the health care team in management of supplements. Major sections present case studies of patients with common conditions and quick reference guides to the use of natural medicines in clinical management of specific disorders.


Medicines for Europe

Medicines for Europe
Author: Brigitte Zimmermann
Publisher:
Total Pages: 87
Release: 1998
Genre:
ISBN: 9783928748230

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WHO Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems

WHO Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems
Author: World Health Organization
Publisher:
Total Pages: 18
Release: 2004-01-01
Genre: Drug monitoring
ISBN: 9789241592215

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Safety is a fundamental principle in the privision of herbal medicines and herbal products for health care and a critical component of quality control. These guidelines provide practical technical guidance for monitoring the safety of herbal medicines with pharmacovigilance systems.


Future Systems

Future Systems
Author: Great Britain. Medicines Control Agency
Publisher:
Total Pages:
Release: 1993
Genre: Pharmacology
ISBN:

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Herbal Medicinals

Herbal Medicinals
Author: Lucinda Miller
Publisher: CRC Press
Total Pages: 412
Release: 1998
Genre: Family & Relationships
ISBN:

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The use of alternative medicines, including herbal medicine and nutritional supplements, is on the rise. The usage of such alternative medications is usually in conjunction with conventional medicine. Now, with Herbal Medicinals as your guide, you can gain an understanding of herbal remedies and how they interact, favorably or unfavorably, with conventional medicines. This new understanding will allow you to give your patients proven advice that keeps them safe while they strive for improved health. The case-based approach in Herbal Medicinals leads you through clinical considerations within the disease state of specific conditions and shows when to address your patients concerning the use or potential use of alternative medicines. You'll find this approach provides an unprecedented combination of clinicians and basic scientists integrating their knowledge for the betterment of patient care. Specifically, you'll learn about: renal implications of herbal remedies hepatic effects of herbal remedies herbs used for fever, influenza, and the common cold use of herbs for gastrointestinal disorders, diabetes mellitus, osteoarthritis/rheumatoid arthritis, asthma, oncology, and dermatology beneficial and adverse effects of herbs on hypertension and hyperlipidemia psychiatric considerations of herb use (e.g., in depression, anxiety) In addition, you'll learn about herb use among substance abusers, the toxicologic considerations of herb use, and regulatory issues concerning herb use. Each chapter in Herbal Medicinals immerses you in cases that illustrate how the presented information can be used in the clinical setting. Summary “pearls” at the end of each chapter allow you quick and easy reference that saves you time. You'll turn to your copy of Herbal Medicinals time and again to find the information you need to meet your patients’many medicinal preferences and needs.