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KMID : 1011520070020010029
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Regulatory Research on Food, Durg and Cosmetic
2007 Volume.2 No. 1 p.29 ~ p.34
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Regulatory Law of Homeopathic Medicinal Products in Germany
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Kim Eun-Mi
Kim Hyoung-Joong
Cho Jeong-Hee
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Abstract
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Homeopathy has a long tradition and a well-established use in Europe including Germany. Even though homeopathic products are highly diluted and assay & identification is impossible, homeopathic medicinal products are medicinal products as defined in Article 1 of the European Council Directive 2001/83 EC and in the Article 2 of German Medicines Act (AMG) because they are presented for treating or preventing disease in human beings or animals. Depending on whether there is indication, there are two kinds of registration procedure in Germany. Homeopathic products without indication shall get registration according to the Article 38 and 39.1 of the German Medicines Act (AMG) and homeopathic products with indication shall get marketing authorization according to the Article 21, 22 of the German Medicine Act (AMG). German pharmacopoeia consists in DAB (Deutsches Arzneibuch), HAB (Homoopathisches Arzneibuch) and European pharmacopoeia according to the Article 55 of German Medicines Act (AMG). Especially in HAB, monograph includes quality control and manufacture of Homeopathic products. As homeopathic products are made from the dilution of mother tincture, assay & identification test may be impossible. According to the Article 2.E.2 of “Allgemeine Verwaltungsvorschrift zur Registrierung homeopathischer Arzneimittel,” when assay & identification test is impossible, the quality shall be demonstrated by complete validation of the manufacturing documentation following to the HAB and the test of mother tincture. In case that assay & identification is impossible, stability test of active ingredients cannot be acquired. It is regulated about it in the Article F.2 of “Allgemeine Verwaltungsvorschrift zur Registrierung homeopathischer Arzneimittel” and “Stability testing for medicinal products prepared in accordance with homeopathic manufacturing procedures.” A marketing authorization following Article 21 of the Medicine Act will be required for homeopathic medicinal products that are presented with indications. Commission D under BfArM is composed of experts according to the Article 7, 25 of German medicinal Act (AMG) and they made monograph of homeopathic products and these monograph can be accepted as an evidence of indication. Indication is written in the Article 26.2 of German medicinal Act and in the Article 5 of “Bekanntmachung der Neufassung der Allgemeinen Verwaltungsvorschrift zur Anwendung der Arzneimittelpruefrichtlinien” and “Commission D guideline: Assessment of fixed combinations of single homeopathic remedies.”
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KEYWORD
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homeopathic products, German pharmacopoeia, assay & identification test, stability test, indication
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