000 01833nam a22003377i 4500
999 _c5515
_d5515
005 20170430143900.0
008 120215s2009 enka | |||| 00| 0 eng d
020 _a9780853697848 (hbk.)
020 _a0853697841 (hbk.)
040 _aFUE
_beng
_erda
082 0 4 _221
_a615.321
_bP.
245 0 2 _aA practical guide to licensing herbal medicinal products /
_cThomas Brendler, L. Denzil Phillips, Stefan Spiess [editors] ; with contributions by Ann Godsell and Birgit Wobst.
264 1 _aLondon :
_bPharmaceutical Press,
_c[2009]
264 4 _c©2009
300 _axxx, 770 pages :
_billustrations ;
_c32 cm
336 _2rdacontent
_atext
337 _2rdamedia
_aunmediated
338 _2rdacarrier
_avolume
500 _aIncludes index.
505 0 _aPart 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
520 _aA 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
650 0 _aMateria medica, Vegetable.
650 0 _aPharmaceutical industry
_xLicenses.
700 1 _aBrendler, Thomas,
_eeditor.
700 1 _aPhillips, L. Denzil,
_eeditor.
700 1 _aSpiess, Stefan,
_eeditor.
700 1 _aGodsell, Ann.
700 1 _aWobst, Birgit.
942 _cREF
_2ddc