Herbal medicinal products in the European Union - AESGP

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Germany In 1994, the Federal Institute for Drugs and Medical Devices (BfArM) replaced the former Federal Health Authority (“Bundesgesundheitsamt” or “BGA”). The BfArM is responsible for the assessment of medicinal products and the verification of submitted dossiers with respect to quality, safety and efficacy. Criteria for registration are set out by EC Directives and Guidelines (such as “Quality of Herbal Remedies” and the European Pharmacopoeia) and by national guidelines and directives (such as the guidelines for testing of drugs (“Arzneimittel-Prüfrichtlinien”) of 5 May 1995 [D 3] based on Section 26 of the Medicines Law. These guidelines implement Council Directive 91/507/EEC into German legislation. Requirements with regard to proof of quality, efficacy and safety are, in principle, the same for all medicinal products, including chemical medicinal products. For well-known substances such as herbal medicinal products, bibliographic data and, for example, Commission-E monographs (see point VII.2.3.) are acceptable to demonstrate efficacy and safety. The quality dossier is checked for each individual case. Whether efficacy is proven by clinical studies, bibliographic data or reference to a monograph (see paragraph on “bibliographic applications”), “normal” indications without any additional term may be claimed. In order to facilitate and speed up the review process, the 5th amendment of the Medicines Law further provided (in Section 105 Paragraph 5c) a possibility for old products to remain on the market until 31 December 2004 provided that the application was withdrawn by 31 December 1995. This deadline was extended to 31 December 1999 by the 6th amendment of the Medicines Law. For these products, the dossiers are no longer checked by the BfArM but remain the full responsibility of the applicant (also under criminal law). Furthermore, they may be controlled and – in cases of risk – withdrawn from the market by the local authorities. Exceptional case: According to Section 36 of the Medicines Law, medicinal products or groups of medicinal products that do not pose a direct or indirect risk to the health of humans or animals may be exempted from the requirement to obtain an individual marketing authorisation. To assure the quality, safety and efficacy of such products, each medicinal product referring to this procedure must comply exactly with a monograph of a standardised marketing authorisation (“Standardzulassung”) published by the Ministry of Health. The monographs include analytical testing requirements as well as the allowable texts for label and package leaflet. Preparations marketed with a standardised marketing authorisation have “normal” indications without any amendment. Data on safety or efficacy are often based on literature or on Commission-E monographs. This regulation is not specific to herbal medicinal products but also covers many chemical substances. In the area of herbal medicinal products, a large number of monographs for standardised marketing authorisation have been published, mainly for herbal teas. If a n application refers to such a monograph, there is no need to present further documentation to the BfArM Greece The Greek Health Authority (EOF) is the competent authority for granting marketing authorisations for medicinal products. EOF procedures on medicinal products follow Community legislation. Until 1 January 1998, Ministerial Decree Y6a/14290/93 [GR 1] was being used. According to this decree, a registration dossier needs to be submitted for herbal medicinal products. Article 3 contains a detailed description of the dossier requirements which comply i n principle with EC legislation. The dossier should be submitted to EOF, which grants or rejects the registration. Section 7 provides detailed instructions for the contents of the package leaflet and the labelling in accordance with the (former) EC Guideline “Quality of Herbal Remedies. Ireland According to the Medical Preparations (Licensing and Sale) Regulations 1998 [IRL 3], a n authorisation is in general required in order that a medicinal product may be imported or 34
placed on the market. The Irish Medicines Board (IMB), which replaced the NDAB on 1 January 1996, is responsible for the licensing of medicinal products. In August 1985, guidelines for the application for a product authorisation of herbal products were issued by the then NDAB [IRL 4] giving information about the requirements to allow assessment of herbal products. These guidelines contain detailed requirements for the plant raw material as well as for the finished product. The herbal product guidelines issued i n 1985 have however largely been superseded by the EC Guideline, particularly in relation to the quality of herbal medicinal products. In relation to safety and efficacy requirements, these are largely consistent with those required for conventional pharmaceutical products hitherto. According to the 1985 NDAB Guidelines, experimental animal studies have to be undertaken to delineate the effects of the contained substances and of the medicinal product. Where possible, comparative studies should be provided with a pure drug substance having a similar effect. The tests should generally include examinations in rodents as well as i n humans. In the case of a drug substance which is likely to be used in association with other drugs, account should be taken of the potential for interaction in terms of therapeutic effects, side effects and toxicity of each drug substance concerned. Each active ingredient should make a relevant and reasonable contribution to the overall therapy, and the quantity of each active ingredient must be effective, safe and appropriate to the recommended use and range of dosage. Detailed requirements for the tests of acute and chronic toxicity have to be fulfilled, e.g. a test for acute toxicity in at least three mammalian species and a detailed list of requirements for the tests of chronic toxicity [IRL 4]. From the viewpoint of the IMB, the requirements in the Notice to Applicants (The Rules Governing Medicinal Products in the European Union) would likely be followed. Italy Herbal medicinal products may be registered with a full or an abridged application based on bibliographic data. The application dossier must contain technical and analytical documentation according to Council Directive 75/318/EEC and the Notice to Applicants (The Rules Governing Medicinal Products in the European Union) [I 8]. With respect to the pharmacological, toxicological and clinical documentation, a bibliographic application i n accordance with the Council Directive 65/65/EEC is possible. Reports of non-clinical or clinical studies that have not been published might be accepted, based on a case-by-case evaluation. It is not envisaged to have a particular commission or group of experts dealing with herbal medicinal products, as in Germany. Luxembourg Luxembourg uses mutual recognition of marketing authorisations granted in other Member States. In practice, Luxembourg does not grant a “first” marketing authorisation but recognises marketing authorisations from other Member States. The Netherlands Herbal medicinal products are assessed using the same procedure and criteria as “regular” (chemical) medicinal products. Portugal In general, the national marketing authorisation procedure for medicinal products is laid down in the Statute of Medicines of 1991 [P 2]. The measures concerning the Community marketing authorisation system (Council Regulation (EEC) No. 2309/93 of 22.7.1993 and Council Directive 93/39/EEC) were incorporated into Portuguese law by a Decree law of 1995 [P 3]. As specific rules on herbal medicinal products are not part of the Portuguese medicines law, herbal medicinal products are subject to the same registration requirements as synthetic medicinal products. Some herbal products have been registered as medicinal products. According to the health authorities, any future developments will depend on the results of the EMEA Ad hoc Working Group on Herbal Medicinal Products. 35
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 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
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
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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
Page 132 and 133:
IX.3.5 Labelling and advertising of
Page 134 and 135:
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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