The New European Union Good Agricultural and Collection Practice Rules: Are Good Practices Good Enough if They Do Not Result in Batch-to-Batch Consistency?

Drug Information Journal

Volumn 37, Issue 3, 2003, Pages 321-327

  Scholten, Willem K ^a  

^a Ministry of Health Welfare and Sport Netherlands   (Netherlands)

Author keywords

European Union; Ginkgo; Good agricultural practice; Herbs; Medicinal cannabis; Opium; Standardization; Starting materials

Indexed keywords

BIFLAVONOID; BILOBALIDE; CANNABIS; FLAVONOID; GINKGO BILOBA EXTRACT; GINKGOLIDE; HERBACEOUS AGENT; OPIATE;

AGRICULTURE; DRUG CONTAMINATION; EUROPEAN UNION; GINKGO BILOBA; GOOD AGRICULTURAL AND COLLECTION PRACTICE; HERB; HERBAL MEDICINE; MICROBIAL CONTAMINATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; REPRODUCIBILITY; REVIEW; STANDARDIZATION;

EID: 0142183566     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150303700308     Document Type: Review

References (6)

1. European Agency for the Evaluation of Medicinal Products. Points to Consider on Good Agricultural and Collection Practice for Starting Materials of Herbal Origin. London, UK: European Agency for the Evaluation of Medicinal Products; May 2002. EMEA/HMPWP/31/99 rev. 3.
2. Itenov K, Molgaard P, Nyman U. Diurnal fluctuations of the alkaloid concentration in latex of poppy Papaver somniferum is due to day-night fluctuations of the latex water content. Phytochemistry. 1999;52:1229-1234.
3. Korthout HAAJ, Beukelman CJ, Wang M. Variatie in samenstelling secundaire metabolieten in Ginkgo biloba extracten (Variation in composition of the secondary metabolites in Ginkgo biloba extracts). Internal report. Nederlandse Organisatie voor toegepast-natuurwetenschappelijlc onderzoek TNO (The Netherlands Organisation for Applied Scientific Research TNO): Leiden; 2002.
4. Scholten WK. Legal aspects on medicinal use of hemp, historic overview and present policy of The Netherlands. Drug Inf J. 2000;34(1):329-332.
5. Scholten WK. Dutch measures to control medical grade marijuana: facilitating clinical trials. Drug Inf J. 2001;35(2):481-484.
6. Regulation of the Minister of Health, Welfare and Sport of 7 January 2003, GMT/BMC 2340685, containing policy guidelines for the decision on applications for Opium Act exemptions (Policy guidelines Opium Act exemptions). State Gazette. January 9, 2003;6:20.