Herbal medicinal products in the european union: Study carried out on behalf of the european commission AESGP

Pharmaceuticals Policy and Law

Volumn 2, Issue , 1999, Pages 51-199

  Cranz, Hubertus ^a   Dechamp, Jean François ^a   Lindberg, Johan ^a   Richter, Rowena K ^a   Steinhoff, Barbara ^a   Coronel, Mary ^a  

^a Assoc Europ Self Medication I   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85013566621     PISSN: 13892827     EISSN: 2210495X     Source Type: Journal    
DOI: None     Document Type: Article

References (128)

1. Quaeyhaegens W., Size and structure of the European Market of Herbal Medicinal Products, Presentation at the AESGP Annual Meeting, Athens, 21-23 May 1998.
2. Official Journal of the European Communities, No. C 305 of 16 October 1987.
3. Official Journal of the European Communities, No. C 350 of 30 December 1995.
4. Official Journal of the European Communities, No. C 136 of 8 May 1996.
5. Official Journal of the European Communities, No. C 141/64 of 13 May 1996.
6. Official Journal of the European Communities, No. C 335/07 of 9 November 1996.
7. [AT 1] Arzneimittelgesetz/Österreich in der Fassung vom 31. Juli 1996 (VO 379/96).
8. [AT 2] 541. Verordnung des Bundesministers für Gesundheit und öffentlicher Dienst vom 16. Oktober 1989 betreffend Erleichterungen bei der Zulassung bestimmter Arzneispezialitäten, Bundesgesetzblatt für die Republik Österreich, 1989, 3641-3666.
9. [AT 3] 727. Verordnung des Bundesministers für Gesundheit, Sport und Konsumentenschutz, mit die der Verordnung betreffend Erleichterungen bei der Zulassung bestimmter Arzneispezialit äten geändert wird, Bundesgesetzblatt für die Republik Österreich, 1992, 3912-3915.
10. [AT 4] Abgrenzungsverordnung vom 25. August 1995 (VO 568/95), Bundesgesetzblatt für die Republik Österreich, 1995, 7005-7046.
11. [AT 5] Arzneispezialitätenverordnung vom 28. Februar 1985 (AspV, VO 82/85), withdrawn by:220. Verordnung der Bundesministerin für Arbeit, Gesundheit und Soziales über die Zulassung von Arzneispezialitäten, Bundesgesetzblatt für die Republik Österreich, 1998, 1115.
12. [AT 6] Kosmetikverordnung vom 12. April 1996 (VO 166/96), Bundesgesetzblatt für die Republik Österreich, 1996, 833-862.
13. [AT 7] Kosmetikverordnung vom 13. August 1997 (VO 22/97), Bundesgesetzblatt für die Republik Österreich,1997, 1115-1124.
14. [B 1] Ministère des Affaires Sociales, de la Santé Publique et de l’Environnement. Arreté royal du 29 aôut 1997 relatif à la fabrication et au commerce de denrées alimentaires composées ou contenant des plantes ou préparations de plantes, Moniteur belge (21 novembre 1997) 97-2706.
15. [B 2] Ministère des Affaires Sociales, de la Santé Publique et de l’Environnement. Circulaire ministérielle du 30 novembre 1994. Directives à la constitution du dossier d’enregistrement des médicaments à base de plantes, Moniteur belge 3103-9 (10 février 1995).
16. [B 3] Ministére des Affaires Sociales, de la Santé Publique et de l’Environnement. Circulaire ministérielle No. 367 du 22 septembre 1989. Directives à l a constitution du dossier d’enregistrement des médicaments à base de plantes.
17. [B 4] Ministère des Affaires Sociales, de la Santé Publique et de l’Environnement. Circulaire ministérielle du 12 mai 1997 modifiant les listes en annexe à l a Circulaire du 30 novembre 1994. Directives à la constitution du dossier d’enregistrement des médicaments à base de plantes, Moniteur belge 3103-9 (10 février 1995).
18. [DK 1] Bekendtgørelse om naturlaegemidler. Sundhedsministeriet nr. 790 af 21. september 1992.
19. [DK 2] Sundhedsstyrelsens vejledning af 30. september 1992 vedrørende registrering af naturlaegemidler. 136
20. [DK 3] Bekendtgørelse om mærkning af og indlaegssedler til lægemidler optaget I Sundhedsstyrelsens specialitetsregister. Sundhedsstyrelsens bekendtgørelse nr. 314 af 18. maj 1993.
21. [DK 4] Bekendtgørelse om reklame for lægemidler. Sundhedsministeriet nr. 736 af 7. August 1996.
22. [FIN 1] Marketing Authorisation for a Herbal Remedy. Administrative Regulation 9/93. National Agency for Medicines. 30 November 1993. Medicines Law, 10 April 1987/395 with all amendments.
23. [F 1] Mélanges de plantes autorisés àetre vendus par les herboristes. Arreté du 7 avril 1943 (Journal Officiel de la République Française (J.O.R.F.) du 4 mai 1943) modifié par Arreté du 27 janvier 1959 (J.O.R.F. du 15 février 1959).
24. [F 2] Vente des plantes servant à la composition de boissons hygiéniques. Loi du 21 juin 1941 (J.O.R.F. du 24 juin 1941). Vente au public de plantes médicinales inscrites à la Pharmacop ée. Décret 79-480 du 15 juin 1979 (J.O.R.F. du 22 juin 1979).
25. [F 3] Circulaire 346 du 2 juillet 1979 (Bulletin Officiel du Ministère de la Santé (B.O.M.S.) du 12 septembre 1979, 79/32) du Ministre de la Santé et de la Famille.
26. [F 4] Médicaments à base de plantes: Les Cahiers de l’Agence No. 3. Agence du Médicament (Note: this document replaces the previous "Avis aux fabricant" published in the Bulletin officiel No. 90/22 of 1990).
27. [D 1] Naturheilmittel und Besondere Therapierichtungen, Bundesgesundheitsblatt 33, 297-301.
28. [D 2] Keller K. Pflanzliche Arzneimittel - rechtlicher Status und offene Forschungsfragen, Forschungsmagazin der Johannes Gutenberg Universität Mainz, Sonderausgabe Naturheilkunde 1992, 59-68.
29. [D 3] Bekanntmachung der Neufassung der Allgemeinen Verwaltungsvorschrift zur Anwendung der Arzneimittel Prüfrichtlinien vom 5. Mai 1995, Bundesanzeiger 1995, 47 No. 96a vom 20. Mai 1995.
30. [D 4] 25. Bekanntmachung über die Verlängerung der Zulassungen nach §105 des Arzneimittelgesetzes (AMG) (Anwendungsgebiete für traditionelle Arzneimittel nach §109a AMG) vom 11. Juli 1995, Bundesanzeiger Nr. 141 vom 29. Juli 1995, 8306-8309.
31. [D 5] Allgemeine Verwaltungsvorschriften zur Anwendung der Arzneimittelprüfrichtlinien vom 14. Dezember 1989, Bundesanzeiger 1989, 41 No. 243a vom 29. Dezember 1989.
32. [GR 1] Minister of Health, Providence & Social Insurance. Ministerial Decree Y6a/14290/93 Government’s Gazette Nr. 217 of 1 April 1994.
33. [GR 2] Medicines Law 1985, last amended by Ministerial Order Nr. 9392/93.
34. [GR 3] Ministerial Decree Y6a/3221, Government Gazette’s No. 782 of 12 September 1995.
35. [GR 4] Ministerial Decree Y6a/776, Government’s Gazette No. 536.
36. [GR 5] Presidential Decree 194, Government’s Gazette No. 102, June 1995.
37. [GR 6] Law 1963/91, Government’s Gazette No. 138.
38. [GR 7] Ministerial Decree Y6/10170 of 19 October 1995.
39. [IRL 1] Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984 (S.I. No. 210 of 1984). Borderline Products. Department of Health, Dublin, April 1988.
40. [IRL 2] Food Supplements & Health Foods. Report to the Minister of Health and the Minister for Agriculture, Food and Forestry, Food Safety Advisory Committee Report No. 16. December 1993.
41. [IRL 3] Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1998 (S.I. No. 142 of 1998).
42. [IRL 4] Guidelines for Application for Product Authorisation of Herbal Products. National Drugs Advisory Board. Dublin: August 1985.
43. [IRL 5] Medicinal Products (Prescription and Control of Supply) Regulations, 1996 (S.I. No. 256 of 1996).
44. [IRL 6] "Fixed Product Combinations". National Drugs Advisory Board. Annual Report 1984.
45. [I 1] Prodotti a base di piante medicinali. Circolare No. 1 (No. 800.7.AG.8/254). Direzione Generale del Servizio Farmaceutico Divisione VII, 08/01/1981.
46. [I 2] D.L.vo n. 111 del 27 January 1992 (pubblicato sulla G.U. No. 39 - 17 febbraio 1992) sulla attuazione della Direttiva 89/398/CEE concernente i prodotti alimentari destinati ad un’alimentazione particolare.
47. [I 3] Circolare n. 13 del 16 October 1997 (pubblicata sulla G.U. No. 269 del 18 novembre 1997) sui medicinali di automedicazione: definizione, classificazione e modello di foglio illustrativo.
48. [I 4] IMS: 1996 data on extracts or active principles of vegetal origin (internal document).
49. [I 5] Table dated 18 February 1998 (document from Indena, Milan, Italy).
50. [I 6] D.L.vo 178/91 (pubblicato sulla G.U. No. 139 del 15 giugno 1991): Recepimento delle Direttive della Comunità economica europea in materia dispecialità medicinali.
51. [I 7] D.L.vo 44/97 (pubblicato sul S.O. alla G.U. No. 54 del 18 febbraio 1997): Attuazione della Direttiva 93/39/CEE, che modifica le Direttive 65/65/CEE, 75/318/CEE e 75/319/CEE relative ai medicinali.
52. [I 8] D.M. 10 marzo 1998 (pubblicato sulla G.U. No. 83 del 9 aprile 1998): Disposizioni sulla documentazione da presentare a corredo delle domande di autorizzazione all’immissione in commercio dei medicinali per uso umano e di modifica dell’autorizzazione.
53. [I 9] D.L.vo. 185/95 (pubblicato sulla G.U. No. 117 del 22 maggio 1995): Attuazione della Direttiva 92/73/CEE in materia di medicinali omeopatici.
54. [I 10] L. 347/97 (pubblicata sulla G.U. No. 241 del 15 ottobre 1997): Disposizioni in materia di commercializzazione di medicinali omeopatici.
55. [I 11] D.L.vo 540/92 (pubblicato sul S.O. alla G.U. No. 7 del 11 gennaio 1993): Attuazione della Direttiva 92/27/CEE concernente l’etichettatura ed il foglietto illustrativo dei medicinali per uso umano.
56. [I 12] D.L.vo 539/92 (pubblicato sul S.O. alla G.U. No. 7 del 11 gennaio 1993): Attuazione della Direttiva 92/26/CEE riguardante la classificazione nella fornitura dei medicinali per uso umano.
57. [I 13] D.L.vo 541/92 (pubblicato sul S.O. alla G.U. No. 7 del 11 gennaio 1993): Attuazione della Direttiva 92/28/CEE concernente la pubblicità dei medicinali per uso umano.
58. [I 14] D.L.vo 538/92 (pubblicato sul S.O. alla G.U. No. 7 del 11 gennaio 1993): Attuazione della Direttiva 92/25/CEE riguardante la distribuzione all’ingrosso dei medicinali per uso umano.
59. [I 15] Lista dei fitoterapici riportati sul Formulario Nazionale della Farmacopea Ufficiale IX Edizione (internal document).
60. [I 16] Formulario Nazionale della Farmacopea Ufficiale IX Edizione: Galenici radizionali - Misceleper tisane (as indicated in [I 15]).
61. [I 17] D.M. 16 aprile 1998 "Approvazione di linee-guida in materia di pubblicità dei lassativi" (pubblicato sulla G.U. n. 92 del 21 aprile 1998).
62. [I 18] XII Commissione Affari Sociali: Testo unificato delle proposte di legge 94.558.639 "Regolamentazione del settore erboristico".
63. [I 19] Corso di diploma universitario in tecniche erboristiche (Tabella XXVIII pubblicata sulla G.U. n. 41 del 19 febbraio 1996).
64. [I 20] Formulario Nazionale della Farmacopea Ufficiale IX Edizione: Galenici tradizionali.
65. [L 1] Table of medicinal plants and/or parts of medicinal plants intended for use as herbal teas which might be delivered to the public by persons other than pharmacists on the condition that the labelling and presentation do not refer to any therapeutic property or favourable effect on the health (Ministry of Health).
66. [NL 1] Wet van 28 juli 1958, Staatsblad 408, houdende nieuwe regeling nopens de geneesmiddelenvoorziening en de uitoefening der artsenijbereidkunst (Wet op de Geneesmiddelenvoorziening).
67. [P 1] Ministério da Saude. Decreto-Lei n.° 353/93 de 7 de Outubro, Diário da República I série A No. 235, 5623-5631 (1993).
68. [P 2] Decreto-Lei n.° 72/91 de 8 Fevereiro 1991.
69. [P 3] Decreto-Lei n.° 272/95 de 23 Outubro 1995.
70. [P 4] Decreto-Lei n.° 101/94 de 19 Avril 1994.
71. [P 5] Decreto-Lei n.° 100/94 de 19 Avril 1994.
72. [P 6] Decreto-Lei n.° 330/90 de 23 Outubro 1990, Com a nova redacção dada pelo Decreto Lei n.° 6/95 de 17 Janeiro 1995.
73. [P 7] Decreto-Lei n.° 135/95 de 9 Junho 1995.
74. [P 8] Instituto Nacional da Farmácia e do Medicamento. Deliberação No. 166/97, Diário da República II série No. 180 de 6 Augustu 1997.
75. [SP 1] Borrador de Real Decreto, por el que se regulan las plantas, las mezclas, los productos y medicamentos a base de plantas medicinales, del 4 de avril de 1998. Draft of a Royal Decree on medicinal products based on plants.
76. [SP 2] Ley 25/1990, de 20 de diciembre 1990, del Medicamento (Boletín Oficial del Estado(B.O.E.) de 22 de diciembre de 1990). (Medicines Law.)
77. [SP 3] Real Decreto 767/1993, de 21 de mayo, por el que se regula la evaluacién, autérizacién, registro y condiciones de dispensacién de especialidades farmacéuticas y otros medicamentos de uso humano fabricados industrialmente (B.O.E. de 2 de julio de 1993). (Royal Decree on the evaluation, authorisation, and sale of medicinal products and other drugs for human use to be manufactured on an industrial basis.)
78. [SP 4] Real Decreto 2000/1995, de 7 de diciembre 1995, por el que se modifica el Real Decreto 767/1993, de 21 de mayo, que regula la evaluacién, autérizacién, registro y condiciones de dispensacién de especialidades farmacéuticas y otros medicamentos de uso humano fabricados industrialmente (B.O.E. de 12 de enero 1996). (Royal Decree modifying Royal Decree 767/1993.)
79. [SP 5] Orden de 3 de octubre de 1973 por la que se establece el registro especial para preparados a base de especies vegetables medicinales (B.O.E. de 15 de octubre de 1973). (Instruction on registration of herbal remedies.)
80. [SP 6] Real Decreto 1564/1992, de 18 de diciembre 1992, pro el que se desarrola y regula el régimen de autorizacién de los laboratorios farmacéuticos e importadores de medicamentos y la garantía de calidad en su fabricacién (B.O.E. de 2 de febrero de 1993). (Royal Decree on pharmaceutical companies.)
81. [SP 7] Real Decreto 3176/1983, de 16 de septiembre 1983, por el que se aprueba l a Reglamentacién Tecnico-Sanitaria para la elaboracién, circulacién y comercio de especias vegetales para infusiones de uso en alimentacién (B.O.E. de 28 de diciembre de 1983). (Technical and sanitary regulation on herbal teas.)
82. [SP 8] Real Decreto 2244/1984, de 26 de septiembre 1983, por el que se aprueba l a Reglamentacién Tecnico-Sanitaria para la elaboracién, circulacién y comercio de condimentos y especias (B.O.E. de 22 de diciembre de 1984). (Technical and sanitary regulation on food additives.)
83. [SP 9] Real Decreto 2236/1993, de 17 de diciembre 1993, por el que se regula el etiquetado y el prospecto de los medicamentos de uso humano (B.O.E. de 18 de febrero de 1994). (Royal Decree on labelling of medicines.)
84. [SP 10] Real Decreto 1416/1994, de 25 de junio 1994, por el que se regula la publicidad de los medicamentos de uso humano (B.O.E. de 29 de julio de1994). (Royal Decree on advertising of medicinal products for human use.)
85. [SP 11] Real Decreto 1354/1983, de 27 de abril 1983, por el que se regula la Reglamentacién Tecnico-Sanitaria para la elaboracién, circulacién y comercio del té y derivados (B.O.E. de 27 de mayo de 1983). (Technical and sanitary regulation on herbal teas.)
86. [S 1] Läkemedelsverkets allmänna råd om godkännande av naturläkemedel för försäljning (LVFS1995:18).
87. [S 2] Läkemedelslag (SFS 1992:859).
88. [S 3] Läkemedelsverkets föreskrifter och allmänna råd (LVFS1995:11)omläkemedelsförpacknin gar och märkning av läkemedel.
89. [S 4] Läkemedelsförordning (SFS 1992:1752).
90. [S 5] Marknadsföringslag (SFS 1995:450).
91. [UK 1] The Medicines Act 1968. London: HMSO, 1968.
92. [UK 2] UK Statutory Instrument 1994 No. 3144, The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994.
93. [UK 3] Medicines Control Agency. A Guide to what is a medicinal product. Medicines Law Leaflet MAL 8. London: December 1995.
94. [UK 4] The Medicines (Exemptions from Licences) (Special and Transitional Cases) Order 1971 (k).
95. [UK 5] The Medicines (Retail Sale or Supply of Herbal Remedies) Order 1977. London: HMSO, 1977 (Statutory Instrument (SI) 1977/2130).
96. [UK 6] The Medicines Labelling (Amendment) Regulations 1992 (SI 1992/3273).
97. [UK 7] The Medicines Leaflets (Amendment) Regulations 1992 (SI 1992/3274).
98. [UK 8] The Medicines (Advertising) Regulations 1994 (SI 1994/1932).
99. [UK 9] The Medicines (Monitoring of Advertising) Regulation 1994 (SI 1994/1993).
100. [UK 10] The Medicines (Advertising) Amendment Regulations 1996 (SI 1996/1552).
101. [CAN 1] TPP Background Information for the Standing Committee on Health, Produced by the Therapeutic Products Programme, Health Canada, November 1997.
102. [CAN 2] Traditional Herbal Medicines, Drugs Directorate Guideline, Health Protection Branch, Canada, 1990.
103. [CAN 3] Policy Issues: Medicinal Herbs in Traditional Herbal Medicines, Bureau of Nonprescription Drugs, The Drugs Directorate, Canada, October 1995.
104. [CAN 4] Homeopathic Preparations: Application for Drug Identification Numbers, Drugs Directorate Guideline, Health Protection Branch, Canada, 1990.
105. [CAN 5] Policy Issues: Indications for Use - Multi-ingredient Low Dilution Homeopathic Preparations, Bureau of Pharmaceutical Assessment, Therapeutic Products Programme, March 1997.
106. [CAN 6] Guideline for Low Dilution Multi-ingredient - Homeopathic Products with Indications for Use, Bureau of Pharmaceutical Assessment, Therapeutic Products Programme, March 1997.
107. [CAN 7] Good Manufacturing Practices, Supplementary Guidelines for the Manufacture of Herbal Medicinal Products, Final Version, Drugs Directorate, Canada, 1996. (1998 version to be available in the near future.)
108. [CAN 8] Policy Issues: Herbs Used as Non-medicinal Ingredients in Nonprescription Drugs for Human Use, Bureau of Nonprescription Drugs, The Drugs Directorate, Health Canada, September 1995.
109. [MEX 1] Bylaws of the General Health Law, 4 February 1998.
110. [MEX 2] Labeling Norm for Medicinal Products.
111. [USA 1] Dietary Supplement Health and Education Act. 1994. Public Law 103-417.
112. [USA 2] Office the Federal Register. 1997. Code of Federal Regulations. Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs. Title 21: Food and drugs, part 330.10 rev. Washington, DC: U.S. Government Printing Office.
113. [USA 3] Office of the Federal Register. 1997. Code of Federal Regulations. Adequate and wellcontrolled studies. Title 21: Food and drugs, part 314.126 rev. Washington, DC: U.S. Government Printing Office.
114. [USA 4] Federal Register. May 11, 1972. 37:9464.
115. [USA 5] Commission on Dietary Supplement Labels. 1997. Report on the Commission on Dietary Supplement Labels.
116. [USA 6] Quote from Prevention Magazine survey. 1997. In: HerbalGram 40.
117. [USA 7] Tom Simone citing data from Information Resources Inc., Chicago. In: Drugstores largest mass-market channel for supplement sales, Natural Business, March 1998.
118. [USA 8] Richman, A. and J.P.Witkowski. 1997. Whole Foods, October. In: Herbalgram 41:53.
119. [USA 9] Office of the Federal Register. 1997. Code of Federal Regulations. Current good manufacturing practice in manufacturing, packing or holding human food. Title 21: Food and drugs, part 110 re v. Washington, DC: U.S. Government Printing Office.
120. [USA 10] Keller, K. 1992. Results of the revision of herbal drugs in the Federal Republic of Germany with a special focus on risk aspects. Zeitschrift für Phytotherapie 116:118.
121. [USA 11] Henry A. Waxman in Hearing of the Subcommittee on Health and Environment, Committee on Energy and Commerce, House of Representatives, 29 July 1993.
122. [USA 12] Tyler, Varro. 1997. When will there come a savior? HerbalGram 41:27-28.
123. [USA 13] Nutrition Labeling and Education Act. 1990. Public Law 101-535.
124. [USA 14] Food and Drug Administration Modernization Act of 1997. Public Law 105-115.
125. [USA 15] Foster, S. ed. 1992. Herbs of Commerce. American Herbal Products Association, Bethesda, MD.
126. [USA 16] Federal Trade Commission Act, 5 U.S.C. 45.
127. [USA 17] Federal Trade Commission. 1994. Enforcement policy statement on food advertising. Federal Register 59:28388-28396.
128. [USA 18] Federal Trade Commission. 1983. Advertising substantiation program; request for comment. Policy statement regarding advertising substantiation. Federal Register 48:10471- 10475.