Herbal medicinal products in the European Union - AESGP

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delineated in Council Directive 75/318/EEC3 as amended. However, the Member States have taken a variety of approaches to meeting these requirements, and in several cases the option exists to supply simplified proof of efficacy in addition to or instead of the proof required for a “full application” (i.e., including a bibliographic or clinical dossier). In this study, particular emphasis is placed on the apparent divergence in the description of the respective application procedures. IV.4 European Pharmacopoeia Since its creation in 1964, the European Pharmacopoeia has dedicated part of its work to the establishment of monographs on herbal drugs which are used either in their natural state after desiccation or concentration or for the isolation of natural active ingredients. 83 monographs have either been published in the European Pharmacopoeia or adopted by the European Pharmacopoeia Commission for publication. An additional 82 monographs are currently in progress, and recently 56 new monographs were authorised by the Commission for elaboration. Most of the existing national pharmacopoeias use the methods of the European Pharmacopoeia in drafting national monographs. Since national authorities also apply the criteria laid down by the European Pharmacopoeia Commission in the establishment of national monographs (e.g. Technical Guide), the possibility exists to transfer such national monographs to the European Pharmacopoeia. IV.5 Bibliographic Applications According to Article 4.8 (a) (ii) of Council Directive 65/65/EEC, “the applicant shall not be required to provide the results of pharmacological and toxicological tests or the results of clinical trials if he can demonstrate ... by detailed references to published scientific literature presented in accordance with the second paragraph of Article 1 of Directive 75/318/EEC that the constituent or the constituents of the medicinal product have a well established medicinal use, with recognised efficacy and an acceptable level of safety.” Therefore, in principle, data from published literature may be used to substantiate safety and efficacy in expert reports and dossiers. Other exemptions from the requirement to submit results of pharmacological and toxicological tests and clinical trials are provided in Article 4.8 (a) (i) (“informed consent”) and Article 4.8 (a) (iii) (“generic applications”) of Council Directive 65/65/EEC, and in Council Directive 92/73/EEC for homeopathic medicinal products. IV.6 The “Scotia” Case The European Court of Justice, in its Judgement of 5 October 1995 in case C-440/93 (The Queen v (1) Licensing Authority of the Department of Health and (2) Norgine Limited, ex parte Scotia Pharmaceuticals Limited), clearly stated that, in terms of the utilisation of bibliographic data according to Article 4.8 (a) (ii) of Council Directive 65/65/EEC, the tests referred to in the data should actually have been carried out previously and that expert reports must be provided in accordance with Council Directive 75/318/EEC. In detail, the Court stated in point 17 of the judgement that: "The abridged procedure in no way relaxes the requirements of safety and efficacy which must be met by medicinal products but is merely intended to shorten the period for preparing an application for authorisation by freeing the applicant from the obligation to carry out the tests specified in point (8) of the second paragraph of Article 4. However, that obligation is replaced by the obligation to demonstrate by detailed references to published scientific literature that the tests listed in the Annex to Directive 75/318 were carried out previously and showed that the constituent or constituents of the medicinal product satisfied the criteria referred to in Article 4." Furthermore, the Court provided the following clarification in point 18: "Nor does recourse to the abridged procedure relax the obligations with which experts must comply by virtue of Articles 1 and 2 of Directive 75/319. Although that procedure substitutes for the requirement to carry out tests the requirement to present, in the form of published references, all the results of the tests performed by other experts, point (b) of the first 3 Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products (OJ L 147 of 9.6.1975, p. 1). 6
paragraph of Article 2 of the directive still requires the analyst, pharmacologist and clinician to provide reports containing the information specified by that provision." An examination of the impact of the interpretation of Article 4.8 (a) (ii) of Council Directive 65/65/EEC by the European Court of Justice on the assessment of marketing authorisation applications for herbal medicinal products in the Member States will be performed i n Chapter VI.2.4 below. 7
Page 1: Herbal medicinal products in the Eu
Page 4 and 5: VII.5 P OST M ARKETING S URVEILLANC
Page 6 and 7: ESCOP and WHO monographs ESCOP as w
Page 8 and 9: For instance, Garlic (Allium sativu
Page 12 and 13: V. ATTEMPTS TO HARMONISE SCIENTIFIC
Page 14 and 15: and Member States recommend that bo
Page 16 and 17: Country National legislation Austri
Page 18 and 19: tinctures, coctions or any other ga
Page 20 and 21: There is for the time being no spec
Page 22 and 23: 18 Medicinal products (“Medicamen
Page 24 and 25: Greece Herbal products that make th
Page 26 and 27: advertisements and the form (tablet
Page 28 and 29: the fight against charlatans, in pa
Page 30 and 31: United Kingdom Peppermint and camom
Page 32 and 33: 12(2) Those restrictions also do no
Page 34 and 35: Ireland Yes Normal procedure Italy
Page 36 and 37: 32 Country Applied Austria Yes Belg
Page 38 and 39: Germany In 1994, the Federal Instit
Page 40 and 41: Spain Registration requirements are
Page 42 and 43: Denmark Bibliographic applications
Page 44 and 45: Products referred to in Section 68,
Page 46 and 47: ibliographic registration dossier f
Page 48 and 49: France According to the French Medi
Page 50 and 51: VII.2.5 ESCOP and WHO Monographs an
Page 52 and 53: Germany • Commission E monographs
Page 54 and 55: 50 Flos Arnicae Flos Calendulae Fol
Page 56 and 57: According to the Agency Instruction
Page 58 and 59: 1978. The regulation is not specifi
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Indication Plants Medicinal plants
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vegetable or animal kingdom, bacter
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Preparations from Indications St. J
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Greece No Yes Yes Ireland N o (Yes)
Page 68 and 69:
is justified. Certain combinations
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The MCA would follow the CPMP Guide
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Spain Magisterial and officinal pre
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Luxembourg The Division of Pharmacy
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Ireland The case has not been encou
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74 • Mild diuretic effect • Mil
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Product Active ingredient Bekunis S
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Senna - constipation Capsicum - mus
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Almost all countries perform GMP in
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Italy In the pharmacovigilance syst
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ecause of defective quality. There
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United Kingdom In early 1997, the M
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Country National legislation Remark
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products. So-called “old” medic
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United Kingdom The major problem wi
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VII.6.4 Application of Council Dire
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Germany According to Section 18 Art
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Luxembourg Council Directive 92/25/
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Italy The sale of medicinal product
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Country Status of distance selling
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IX. LEGAL REQUIREMENTS AND THE ASSE
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and minerals may be recommended for
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submit clinical studies and other s
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IX.1.4 Post-marketing surveillance
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materials that have well recognised
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The Department of Herbal Medicinal
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Ingredients Indications Senna fruit
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c ) Are distance selling and telesh
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e ) Are there “combination produc
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Section 4 of the Dietary Supplement
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homeopathic products are regulated
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Finally, FDA suggested that the pri
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IX.3.5 Labelling and advertising of
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As mentioned under question 5.1, th
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Germany Dr Konstantin Keller Federa
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Yale University, New Haven, Connect
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[DK 3] Bekendtgørelse om mærkning
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[I 17] D.M. 16 aprile 1998 "Approva
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[CAN 5] Policy Issues: Indications
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XII. ANNEXES XII.1 List of Acronyms
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XII.2 List of Tables Table 1: Docum
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