TY - BOOK AU - Brendler,Thomas AU - Phillips,L.Denzil AU - Spiess,Stefan AU - Godsell,Ann AU - Wobst,Birgit TI - A practical guide to licensing herbal medicinal products SN - 9780853697848 (hbk.) U1 - 615.321 21 PY - 2009///] CY - London PB - Pharmaceutical Press, KW - Materia medica, Vegetable KW - Pharmaceutical industry KW - Licenses N1 - Includes index; Part One - Product Eligibility; Classification of herbal (medicinal) products; Part Two - Content and Presentation; Proof of tradition; Common technical document; Good agricultural and collection practice; Quality requirements for traditional herbal medicinal products; Safety and pharmacovigilance; Labelling; Part Three - The Practicalities; Submission of THM registration application-frequently asked questions; Part Four - Appendices; EU-EMEA documents; PhEur documents; Commission E monographs N2 - A guide to aid pharmaceutical companies with registration of herbal products. It includes information and documents in the registration procedure from initial decision making through to receiving a license or rejection ER -