Herbal medicinal products in the European Union - AESGP

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ibliographic registration dossier for a herbal medicinal product that meets the requirements of Article 1 of Council Directive 75/318/EEC. For bibliographic documentation on clinical efficacy of an extract, the MEB is of the opinion that all extracts are not equivalent. Therefore there must be similarity between the extract described in the supporting literature and the herbal medicinal product in the application. Portugal Reference to literature is in principle accepted. Spain According to Royal Decree 767/1993 [SP 3], pharmacological, toxicological and clinical studies may in principle for non-prescription medicinal products be replaced by bibliographic documentation. According to information from the Directorate General of Pharmacy and Sanitary Products, it is sufficient in case of herbal medicinal products to make reference to a monograph. Sweden According to the MPA’s Guidelines on marketing authorisation for natural remedies (LVFS 1995:18) [S 1], regarding safety consideration should primarily be given to experience with the use of the product or its constituents, and it should be demonstrated that no harmful effects have been reported or are being suspected. If satisfactory proof of safety is not provided, this should be established by means of clinical trials and/or pharmacological and toxicological studies. Even if the experience of long-term use of a natural remedy does not indicate that it has any harmful effects, this cannot always be assumed to be proof of the remedy’s safe use. By definition, natural remedies may only be marketed with indications for diseases or symptoms of diseases which are temporary or mild in nature, i.e. for diseases or conditions that are suitable for self-medication. The fields that may be approved for natural remedies at a later date depend on the supporting documentation provided in the application. For well-documented ingredients or products for which there is adequate experience, reliable bibliographic data may be sufficient to support statements about a natural remedy’s efficacy. However, the precondition is that the product’s formulation, use and dosage, etc. do not deviate from those traditionally described. In cases where the product’s properties deviate from the traditional description, the application is to be supplemented by specific productrelated documentation in accordance with the MPA’s Guidelines on the documentation of natural remedies, Part IV, efficacy documentation. A specific statement on traditional use should be included in the label. United Kingdom In principle, the MCA accepts bibliographic proof of efficacy under 4.8 (a) (ii) for all herbal medicinal products, but this has to satisfy all the requirements of Council Directives 75/318/EEC and 75/319/EEC. For products well-established in the United Kingdom, the applicant has to submit the actual documentation (i.e. provide the MCA with copies of the documents, not only refer to it). Documents have to be in English, otherwise they have to be translated. The full package should be provided, and there must be an expert report. For products not already licensed in the United Kingdom, the application is treated as a New Chemical Entity (NCE). The problem of the bibliographic proof of efficacy under Article 4.8 (a) (ii) of Council Directive 65/65/EEC is the concept of essential similarity. Summary The option of bibliographic application is available in the following Member States: Country Option of bibliographic application Austria Yes - only for safety documentation Belgium Yes - in principle 42
Denmark Yes - as the only way in practice Finland Yes - as the only way in practice France Yes - in principle Germany Yes Greece Yes Ireland Yes - on a case-by-case basis Italy Yes Luxembourg Yes The Netherlands Yes - in principle Portugal Yes - in principle Spain Yes - in principle Sweden Yes United Kingdom Yes Table 8: Option of bibliographic application It can be demonstrated that the option of bibliographic application is available i n all Member States except in Austria, where it is only accepted for the safety documentation. The option of bibliographic application is however sometimes only available through assessment on a case-by-case basis, or in several cases it i s not used in practice. VII.2.4 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), 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 i n the data should actually have been carried out previously and that expert reports must be provided in accordance with Council Directive 75/318/EEC. National authorities have been asked about the implications of this interpretation by the European Court of Justice in the assessment of applications for marketing authorisation of herbal medicinal products. The replies from the national health authorities are given below. Austria The Federal Ministry of Labour, Health and Social Affairs considers that this is a general question concerning acknowledgement of bibliographic material. If the preparation is already authorised according to European law, bibliographic material is accepted for a preparation containing the same active ingredient. The expert has to decide in his critical evaluation whether it is the “same” active ingredient, e.g., if it contains the same characteristic compounds. Belgium There have not been any examples of a similar case. The Ministry of Public Health considers that this has to be discussed at the European level in order to avoid further cases. Denmark According to the Danish Medicines Agency, there are no implications of the “Scotia” case for herbal medicinal products. Expert reports are currently not required (the new legislation will include this requirement). The Danish Medicines Agency considers that, according to the “Scotia” case, this is in conflict with the interpretation of Article 4.8 (a) (ii) of Council Directive 65/65/EEC made by the European Court of Justice. Finland According to National Agency for Medicines (NAM), there are no implications of the “Scotia” case for herbal medicinal products. 43
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 10 and 11: delineated in Council Directive 75/
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 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
Page 60 and 61: Indication Plants Medicinal plants
Page 62 and 63: vegetable or animal kingdom, bacter
Page 64 and 65: Preparations from Indications St. J
Page 66 and 67: Greece No Yes Yes Ireland N o (Yes)
Page 68 and 69: is justified. Certain combinations
Page 70 and 71: The MCA would follow the CPMP Guide
Page 72 and 73: Spain Magisterial and officinal pre
Page 74 and 75: Luxembourg The Division of Pharmacy
Page 76 and 77: Ireland The case has not been encou
Page 78 and 79: 74 • Mild diuretic effect • Mil
Page 80 and 81: Product Active ingredient Bekunis S
Page 82 and 83: Senna - constipation Capsicum - mus
Page 84 and 85: Almost all countries perform GMP in
Page 86 and 87: Italy In the pharmacovigilance syst
Page 88 and 89: ecause of defective quality. There
Page 90 and 91: United Kingdom In early 1997, the M
Page 92 and 93: Country National legislation Remark
Page 94 and 95: 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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