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Regulatory Situation of Herbal Medicines A worldwide Review

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WHO/TRM/98.1page 40Morris Arboretum Symposium, Philadelphia, 19-21 April 1993.[25] Kuipers SE, Farnsworth NR, Fong HMS, Segelman AB. <strong>Herbal</strong> <strong>Medicines</strong> - A Continuing World Trend. Presentationat the 1st World Federation <strong>of</strong> Proprietary Medicine Manufacturers Asia Pacific Regional Meeting, Jakarta.Unpublished.[26] The Dietary Supplement Health and Education Act <strong>of</strong> 1994. Pub. L. No. 103-417 Washington.[27] Marwick C. Growing Use <strong>of</strong> Medicinal Botanicals Forces Assessment by Drug Regulators. JAMA 1995;273:607-609.[28] Ministry <strong>of</strong> Health <strong>of</strong> the Sultanate <strong>of</strong> Oman. Conditions to allow import <strong>of</strong> traditional drugs, either Chinese/Indian orany other Origin (information sheet) Muscat, 1995.[29] Regulations for Registration <strong>of</strong> <strong>Herbal</strong> preparations, Health and Supplementary Food, Cosmetics and Antisepticsthat have Medicinal Claims. Kingdom <strong>of</strong> Saudi Arabia, Ministry <strong>of</strong> Health, General Directorate <strong>of</strong> Medical andPharmaceutical Licences, Directorate <strong>of</strong> Pharmaceutical Licences.[30] Council Directive 65/65/EEC <strong>of</strong> 26 January 1965 on the approximation <strong>of</strong> provisions laid down by law, regulation oradministrative action relating to proprietary medicinal products. Official Journal <strong>of</strong> the European Communities nE 22<strong>of</strong> 9 February 1965.[31] Council Directive 75/318/EEC <strong>of</strong> 20 May 1975 on the approximation <strong>of</strong> the laws <strong>of</strong> Member States relating toanalytical, pharmacotoxicological and clinical standards and protocols in respect <strong>of</strong> the testing <strong>of</strong> proprietarymedicinal products. Official Journal <strong>of</strong> the European Communities nE L 147 <strong>of</strong> 9 June 1975.[32] Commission Directive 91/507/EEC <strong>of</strong> 19 July 1991 modifying the Annex to Council Directive 75/318/EEC on theapproximation <strong>of</strong> the laws <strong>of</strong> Member States relating to analytical, pharmacotoxicological and clinical standards andprotocols in respect <strong>of</strong> the testing <strong>of</strong> medicinal products. Official Journal <strong>of</strong> the European Communities nE L. 270/32<strong>of</strong> 26 September 1991.[33] Council Directive 75/319/EEC <strong>of</strong> 20 May 1975 on the approximation <strong>of</strong> provisions laid down by law, regulation oradministrative action relating to proprietary medicinal products. Official Journal <strong>of</strong> the European CommunitiesnE L 147 <strong>of</strong> 9 June 1975.[34] Council Directive 93/39/EEC <strong>of</strong> 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC inrespect <strong>of</strong> medicinal products. Official Journal <strong>of</strong> the European Communities nE L 214 <strong>of</strong> 24 August 1993.[35] Quality <strong>of</strong> <strong>Herbal</strong> Remedies. In: The Rules governing Medicinal Products in the European Community, Vol. III.Guidelines on the quality, safety and efficacy <strong>of</strong> medicinal products for human use. Luxembourg: Office for OfficialPublications <strong>of</strong> the European Communities, 1989.[36] European Phytotelegram. Sixth issue. - August 1994.[37] Coordinated <strong>Review</strong> <strong>of</strong> Monographs on <strong>Herbal</strong> Remedies. SPCs adopted by the CPMP at its May 1994 Meeting.European Commission, Directorate General III. Brussels, 18 May 1994.[38] Steinh<strong>of</strong>f, B.European monographs - a scientific basis for harmonization? Z Phytotherapie Abstractband 1995: 20.[39] Monographs on the Medicinal Use <strong>of</strong> Plant Drugs. Fascicules 1 and 2. European Scientific Cooperative onPhytotherapy 1996.[40] Arzneimittelgesetz. Bundesgesetzblatt für die Republik Österreich Nr. 185/1983, geändert durch BundesgesetzeBGBl. Nr. 748/1988, Nr. 45/1991 und .../1993.[41] 541. Verordnung des Bundesministers für Gesundheit und öffentlicher Dienst vom 16. Oktober 1989 betreffendErleichterungen bei der Zulassung bestimmter Arzneispezialitäen. Bundesgesetzblatt für die Republik Österreich1989:3641-3666.[42] 727. Verordnung des Bundesministers für Gesundheit, Sport und Konsumentenschutz, mit der die Verordnungbetreffend Erleichterungen bei der Zulassung bestimmter Arzneispezialitäten geändert wird. Bundesgesetzblatt fürdie Republik Österreich 1992:3912-3915.

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