German comments on REVISED DRAFT for discussion 2011 LIST OF TERMS USED IN HOMEOPATHY Related to homeopathic medicinal products as defined by Directive 2001/83/EC, as amended. Note: It should be generally discussed whether the translation of terms in national languages should be the verbal translation or the correct national term. 1 Introduction: Following the mandate of the Homeopathic Medicinal Products Working Group (HMPWG), the group shall be a forum for exchange of regulatory and scientific expertise regarding the assessment of the quality and safety of homeopathic medicinal products for human and veterinary use in the Member States, and provide guidance on the assessment of homeopathic medicinal products by Competent Authorities. For reasons of harmonization, a list of terms used in homeopathy is drafted, which shall be published. Inclusion of terms specific to homeopathy and homeopathic therapy is not a result of any scientific evaluation, or endorsement, but is exclusively based on the homeopathic therapy as it is traditionally used in Member States. The first chapter contains definitions derived from European legislation or from the European Pharmacopoeia or national pharmacopoeias officially used in Member States. The second chapter lists definitions from other references. For each chapter, terms are presented in alphabetical order. If possible, the text of the definitions is also given in the original European language of the official reference, and the pharmaceutical or medical background is clarified. Chapter 1 List of terms defined by European legislation and the European Pharmacopoeia or national pharmacopoeias, officially used in Member States. Chapter 2 Other definitions Chapter 3 References 2 CHAPTER 1 Definitions from European legislation and from European Pharmacopoeia or in absence thereof, from national pharmacopoeias officially used in Member States. 1. Dosage forms: A dosage form of a homeopathic preparation complies with any relevant dosage form monograph in the European Pharmacopoeia, and with the following: - for the purpose of dosage forms for homeopathic use, “active substances” are considered to be dilutions or triturations of homeopathic stocks. - these dosage forms are prepared using appropriate excipients - A test for uniformity of content or uniformity of dosage units can be required. Dosage form: Pillule See under “Pillule” Dosage form: Tablet See under “Tablet” Dosage form: Drops See under “Oral drops, solution” Dosage form: Gel See under “Gel” Dosage form: Cream See under “Cream” Dosage form: Oral powders See under “Oral powder” Reference: European Pharmacopoeia, monograph 1038 2. Glycerol macerates: D: Fr: It: NL: Glycerolmazerat Macérat glycériné Macerati glicerici Glycerinemaceraat Glycerol macerates are liquid preparations obtained from raw materials of botanical, zoological or human origin by using glycerol or a mixture of glycerol and either alcohol of a suitable concentration or a solution of sodium chloride of a suitable concentration. Reference: 3. D: Fr: It: NL: European Pharmacopoeia, monograph 1038 Herbal drugs for homeopathic preparations Pflanzliche Drogen für homöopathische Zubereitungen Drogues végétales pour préparations homéopathiques Droghe vegetali per preparazioni omeopatiche Plantaardige bestanddelen voor homeopathische bereiding 3 Synonyms: botanical substances, herbal substances Herbal drugs for homeopathic preparations are mainly whole plants or parts of plants, fragmented or broken, and include algae, fungi or lichens in an unprocessed state, usually in fresh form. The state, fresh or dried, in which the drug is used, is defined in the individual monograph of the European Pharmacopoeia, or in its absence, in the individual monograph of an official national Pharmacopoeia of a Member state. In the absence of such a monograph, the state in which the herbal drug is used has to be defined. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal drugs for homeopathic preparations. Herbal drugs for homeopathic preparations are precisely defined by the botanical scientific name of the source species (in Latin) according to the binomial system (genus, species, variety and author). Reference: European Pharmacopoeia, monograph 2045 4. Methods of preparation of homeopathic stocks and potentisation: D: Fr: It: NL : Vorschriften zur Herstellung homöopathischer konzentrierter Zubereitungen und zur Potenzierung Méthodes de fabrication homéopathiques Metodi di produzione omeopatici Homeopathische bereidingsmethodes Homeopathic stocks are prepared, using suitable methods, from raw materials that comply with the requirements of the European Pharmacopoeia monograph Homeopathic preparations (Ph.Eur. 1038). The methods described in the European Pharmacopoeia, combined with established methods for potentisation, are examples of methods. Homeopathic manufacturing methods described in an official national pharmacopoeia of a Member State may equally be used. Reference: European Pharmacopoeia, monograph 2371 5. D: Fr: It: NL: Homeopathic medicinal product: Homöopathisches Arzneimittel Médicament homéopathique Medicinale omeopatico Homeopathisch geneesmiddel Synonyms: homeopathic medicine homeopathic finished product homeopathic product Any medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States. A homeopathic medicinal product may contain a number of principles. Reference: Directive 2001/83/EC, article 1.5 4 6. D: Fr: It: NL: Homeopathic preparation: Homöopathische Zubereitung Préparation homeopathique Homeopathische bereiding Synonym: homeopathic intermediate Homeopathic intermediate product Homeopathic preparations are prepared from substances, products or preparations called stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in a Member State. A homeopathic preparation is usually designated by the Latin name of the stock, followed by an indication of the degree of dilution. A homeopathic preparation can be processed into a homeopathic medicinal product, or can act as an intermediate product in the production of higher dilutions. Reference: European Pharmacopoeia monograph 1038 and Directive 2001/83, as amended 7. Homeopathic stock: Synonym: D: Fr: It: NL: Stock Konzentrierte Zubereitung Souche / souche homéopathique Materiale di partenza per preparazioni omeopatiche/ceppo omeopatico Homeopathische grondstof Homeopathic Stocks are substances, products or preparations used as starting materials for the production of homeopathic preparations. A stock is usually one of the following: - a mother tincture or a glycerol macerate, for raw materials of botanical, zoological or human origin, or - the substance itself, for raw materials of chemical or mineral origin Reference: European Pharmacopoeia, monograph 1038 8. Mother tincture: Synonym: D: Fr: It: NL : Urtinktur Teinture mère Tintura madre oertinctuur (Ø), moedertinctuur (MT, TM) Symbols: MT, TM, Ø 5 Mother tinctures for homeopathic preparations are liquid preparations obtained by the solvent action of a suitable vehicle upon raw materials. The raw materials are usually in the fresh form but may be dried. Mother tinctures for homeopathic preparations may also be obtained from plant juices, with, or without the addition of a vehicle. For some preparations, the matter to be extracted may undergo a preliminary treatment. Mother tinctures comply with the requirements of the European Pharmacopoeia monograph Mother tinctures for homeopathic preparations (2029). Reference: European Pharmacopoeia, monograph 2029, 1038 9. Oral drops, solution: Synonym: oral drops, oral solution D: AUS: Fr: It: NL: Mischung, Flüssige Verdünnung, Lösung Tropfen zum Einnehmen, Lösung Solution buvable en gouttes Gocce orali Druppels voor oraal gebruik, oplossing Liquid preparations for oral use are usually solutions, emulsions or suspensions containing one or more active substances in a suitable vehicle. Reference: European Pharmacopoeia, monograph 0672 10. Pillule Synonym: microglobule, globule, granule (depending on the size) D: Fr: It: NL: Streukügelchen(Globuli), und Globuli velati Granules / (granules en recipient unidose) Granuli Granule, globuli, microglobuli Pillules for homeopathic use are solid preparations obtained from sucrose, lactose or other suitable excipients. They may be prepared by impregnation of preformed pillules with a dilution or dilutions of homeopathic stocks or by progressive addition of these excipients and (the addition of) a dilution or dilutions of homeopathic stocks. They are intended for oral or sublingual use. Reference: European Pharmacopoeia, monograph 1038, European Pharmacopoeia Standard terms 6 11. Potentisation: Synonym: D: Fr: It: NL: homeopathic dilution process Potenzierung Déconcentrations Dynamisation [BEL] Processo di potenziamento (o dinamizzazione) homeopathische potentiëring Dilutions and triturations are obtained from stocks by a process of potentisation in accordance with a homeopathic manufacturing procedure as described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States. This means successive dilutions and succussions, or successive appropriate triturations, or a combination of the two processes. Reference: European Pharmacopoeia, monograph 1038, 12. Potentisation steps: D: Fr: It: NL: Potenzierungsstufen Opérations de déconcentration Operazioni di potenziamento Verdunningsstappen The potentisation steps are usually one of the following: - 1 part of the stock plus 9 parts of the vehicle; they may be designated as D, DH, or X (decimal); 1 part of the stock plus 99 parts of the vehicle; they may be designated as C, or CH (centesimal) LM, (or Q-) potencies are manufactured according to a specific manufacturing method. The number of potentisation steps defines the degree of dilution: for example “D3”, “3DH” or “3X” means 3 decimal potentisation steps, and “C3”, “3CH” or “3C” means 3 centesimal potentisation steps. Reference: European Pharmacopoeia, monograph 1038 13. Raw material: D: Fr: It: NL: Ausgangsstoffe Matière première Materia prima Uitgangsstoffen, ruwe grondstoffen Raw materials for the production of homeopathic preparations may be of natural or synthetic origin. For raw materials of zoological or human origin, adequate measures are 7 taken to minimise the risk of agents of infection, including viruses (5.1.7), in the homoeopathic preparations. A raw material of botanical, zoological or human origin may be used either in the fresh or in the dried state. Where appropriate, fresh material may be kept deep-frozen. Raw materials of botanical origin comply with the requirements of the European Pharmacopoeia monograph Herbal drugs for homeopathic preparations (Ph.Eur. 2045). Where justified and authorised for transportation or storage purposes, fresh plant material may be kept in ethanol (96 per cent V/V) or in alcohol of a suitable concentration, provided the whole material including the storage medium is used for processing. Raw materials comply with any requirements of the relevant monographs of the European Pharmacopoeia. Reference: European Pharmacopoeia, monograph 1038 Also: Starting material: Raw materials of herbal, mineral, animal or chemical origin can be used as starting materials for the manufacture of homeopathic preparations. References: Directive 2003/63/EC European Pharmacopoeia, monograph 2045 14. Tablet: D: Fr: It: NL: Tabletten Comprimé Compressa Tablet Tablets for homeopathic use are solid preparations obtained from sucrose, lactose or other suitable excipients according to the European Pharmacopoeia monograph Tablets (Ph.Eur. 0478). They may either be prepared by compressing one or more solid active substances with the excipient/s or by impregnating preformed tablets with a dilution or dilutions of homeopathic stocks. The preformed tablets for impregnation are obtained from sucrose, lactose or other suitable excipients according to the monograph Tablets (Ph.Eur. 0478). They are intended for oral or sublingual use. Reference: European Pharmacopoeia, monograph 1038, European Pharmacopoeia Standard terms 15. Vehicle: D: Fr: It: NL: Arzneiträger Vehicule /excipient Veicolo excipiens, hulpstof Vehicles are excipients used for the preparation of certain stocks or for the potentisation process. They may include, for example: purified water, alcohol of a suitable concentration, glycerol and lactose. 8 Vehicles comply with any requirements of the relevant monographs of the European Pharmacopoeia. Reference: European Pharmacopoeia, monograph 1038 16. Oral Powder: D: Fr: It: NL: Verreibung, Mischung aus Verreibungen poeder voor oraal gebruik Oral powders are preparations consisting of solid, loose, dry particles of varying degrees of fineness. They contain one or more active substances, with or without excipients and, if necessary, colouring matter authorised and flavouring substances by the competent authority. They are generally administered in or with water or another suitable liquid. They may also be swallowed directly. They are presented as single-dose or multidose preparations. Where applicable, containers for oral powders comply with the requirements of Materials used for the manufacture of containers (3.1 and subsections) and Containers (3.2 and subsections). Multidose oral powders require the provision of a measuring device capable of delivering the quantity prescribed. Each dose of a single-dose powder is enclosed in an individual container, for example a sachet or a vial. Reference: European Pharmacopoeia, monograph 1165 17. Cream: D: Fr: It: NL: Creme crème 18. Gel: D: Fr: It: NL: Gel gel Semi-solid preparations for cutaneous application are intended for local or transdermal delivery of active substances, or for their emollient or protective action. They are of homogeneous appearance. Semi-solid preparations for cutaneous application consist of a simple or compound basis in which, usually, 1 or more active substances are dissolved or dispersed. According to its composition, the basis may influence the activity of the preparation. The basis may consist of natural or synthetic substances and may be single phase or multiphase. According to the nature of the basis, the preparation may have hydrophilic or 9 hydrophobic properties; it may contain suitable excipients such as antimicrobial preservatives, antioxidants, stabilisers, emulsifiers, thickeners and penetration enhancers. Semi-solid preparations for cutaneous application intended for use on severely injured skin are sterile. Where applicable, containers for semi-solid preparations for cutaneous application comply with the requirements of Materials used for the manufacture of containers (3.1 and subsections) and Containers (3.2 and subsections). Several categories of semi-solid preparations for cutaneous application may be distinguished: — ointments; — creams; — gels; — pastes; — poultices; — medicated plasters. According to their structure, ointments, creams and gels generally show viscoelastic behaviour and are non-Newtonian in character e.g. plastic, pseudoplastic or thixotropic type flow at high shear rates. Pastes frequently exhibit dilatancy. Reference: European Pharmacopoeia, monograph 0132 10 CHAPTER 2 Other Definitions Belgium will propose a separate definition for homeopathic proving and pathogenesis. Homeopathic Proving: D: Fr: It: NL: Geneesmiddelenproef Pathogenesis: D: Fr: It: NL: Geneesmiddelbeeld 19. Homeopathic medicinal products for anthroposophic use (Anthroposophic medical product) D: Fr: It: NL : Homöopathisches Arzneimittel der anthroposophischen Therapierichtung Médicament homéopathique traditionnellement utilisé en Anthroposophie Homeopathisch geneesmiddel toegepast op basis van de principes van de antroposofische geneeswijze. Anthroposophic medicinal products manufactured according to a homeopathic manufacturing procedure method described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States have be considered as homeopathic medicinal products in accordance with the Directive 2001/83/ EC. They are used in accordance with the anthroposophic view of the human being. Directive 2001/83/EC, Whereas (22), article 1.5 20. Biological substances for homeopathic preparation: Starting materials of biological origin may be obtained from: - humans, e.g. human cell lines, healthy tissues or fluids, or material from human lesions or infected materials; - animals (e.g. whole animals, organs, tissues, animal secretions, toxins, healthy or diseased tissues and extracts (nosodes)*, animal blood products, parasites, cell lines); - micro-organisms (e.g. bacteria, viruses, microscopic fungi, plant parasites) 11 - Parts of plants, plant secretions, extracts, pollen, plant cell lines, macroscopic fungi, etc. Reference: HMPWG Paper “Points to consider on Safety of Homeopathic medicinal products from Biological origin” (July 2007) *GER agrees to leave it 21. Centesimal potencies: Synonyms: D: Fr: It: NL: C, CH Centesimal potency C-Potenzen, Centesimalverdünnung Dilutions Centésimale (C) , Dilutions Centésimale Hahnemannienne (CH) Diluizioni centesimali Centesimale verdunning Centesimal potencies are prepared using a homeopathic manufacturing method involving dilution steps of one part in a hundred. CH = centesimal according to Hahnemann (the way Hahnemann prescribed) 22. Chemical substances for homeopathic preparation: Chemical substances (organic and inorganic) are dissolved in alcohol of a suitable concentration, glycerol, purified water and water for injections, or triturated with lactose, depending on chemical properties of the substance. 23. Classical homeopathy Synonyms :Unitarian homeopathy, Unicism, Kent’s homeopathy, constitutional homeopathy In France: Unicism D: Fr: It: NL: Klassische Homöopathie Homéopathie uniciste Omeopatia unicista Klassieke Homeopathie Method of homeopathic practice using a single homeopathic medicinal product, (homeopathic substance derived from a single raw material/stock according to the homeopathic principles) and usually administered to a patient in rather high potencies (e.g. above D8), purely based on the Similia principle. 24. Clinical homeopathy: 12 D: Fr: It: NL: Klinische Homöopathie Homéopathie pluraliste Omeopatia clinica Klinische homeopathie Method of homeopathic practice based mainly on the clinically most prominent symptomatologies and on the predominant relation with somatic complaints, organ and tissue affinities, and clinical disease. Often combination products are used lower potencies (e.g. below C30) considered as pragmatic homeopathic approach in primary care. In France defined als Pluralism: Method of homeopathic practice using several homeopathic medicines, based on the Similia principle. 25. Complex homeopathy: Synonym: combination therapy D: Fr: It: NL : Komplexhomöopathie Homéopathie complexiste Omeopatia complessa Complex-homeopathie Method of homeopathic treatment using more than one homeopathic preparation combined in a single homeopathic medicine, usually taken more than once daily. Prescribed on the basis of a pre-defined indication. German Comment: 24 and 25 are not really to be separated. Both are working with known symptomatologies and indications, the only difference are monopreparations and combinations, which can be addressed in one topic. 26. Decimal potencies: Synonyms: D: Fr: It: NL : D, DH, X Decimal potency D-Potenzen, Dezimalverdünnung Dilutions décimales Hahnemanniennes DH Diluizioni decimali Decimale verdunning Decimal potencies are prepared using a homeopathic manufacturing method involving dilution steps of one part in ten. 27. Dilutions, grades of: Examples of low, medium and high potencies: see table Low potencies: Medium potencies: D4, D6 FR: D4 to D10 D8 to D23 C2, C3 FR: C2 to C5 FR: D12 to D18 C4 to C12 13 High potencies: C12, C15, C30, C200, C1000 D24, D30, D60, D200 MK, XMK, 50MK, CM, MM D: Tiefpotenzen Fr: Basses dilutions It: Basse diluizioni NL: lage potenties FR: C6 to C9 LM potencies D: Mittlere Potenzen Fr: Dilutions moyennes It: Medie diluizioni D: Hochpotenzen Fr: Hautes dilutions It: Alte diluizioni NL: hoge potenties German Comment: In 26 and 27 the terms dilutions and potencies are used equivalent, which is not the case. GER thinks we should be consistent, either differentiating them or defining them as equivalents. 28. Drinkable ampoules (Drink ampoules): D: Fr: It: NL : Trinkampullen Solution buvable en ampoules Fiale per uso orale Drinkampullen Traditional pharmaceutical form made of a cylindrical glass recipient, closed at the ends “in points, containing a single dose of a homeopathic preparation. Not an official standard term as a pharmaceutical dosage form. German comment: There is no regulatory basis for drinking ampoules in Germany. We have heard about this of-lable-use of ampoules for injection in anthroposophy / homeopathy but there is no legal marketing authorisation for this kind of products and route of application. 29. Gemmotherapy: D: It: NL: Gemmotherapie Fr: Gemmothérapie Gemmoterapia Gemmotherapie This therapy uses glycerine macerates prepared from embryonic plant tissue (buds) of a defined range of plants, harvested at a time when this is in the process of incipient growth. Not considered as part of homeopathy in every Member State. Not based on homoepathic provings and the remedies are prescribed in low potencies (D1) according to clinical indication, used in French and Belgium. 30. Homeopathic aggravation: Synonyms: Homeopathy does not know side effects. D: Erstverschlimmerung AUS: Erstreaktion Fr: Aggravation des symptomes It: Aggravamento omeopatico NL: Beginverergering 14 According to homeopathic theory, a worsening of existing symptoms of a patient in response to a homeopathic medicine. This reaction is said to be due to a so-called “artificial disease” that is produced by the homeopathic remedy. It is often considered to be a confirmation that the correct “simile” is prescribed. 31. Homeopathy: Homeopathy is a therapeutic system which is based on the so-called Law of Similars. In order to cure or improve the health of a patient the individual symptoms are taken and a remedy is prescribed that is known to produce similar symptoms when given to a healthy person. Homeopathy was founded by Samuel Hahnemann (1755-1843). He published his theory of homeopathy 1810 in the “Organon of the Rational System of Medicine” 32. K-potencies Synonyms: Korsakov (-ff) potencies, Korsakovian-potencies D: Fr: It: NL: Korsakoff-Potenzen Dilutions Korsakoviennes Diliuzioni Korsakowiane Korsakov potenties. Homeopathic preparations that have been prepared using the Korsakov method: In the process of serial dilution only one container is used throughout the process. Each dilution factor corresponds approximately with a ratio 1:100. The method is described in the Homeopathic Pharmacopoeia of the United States, part General pharmacy, chapter 11 – Liquid attenuations, under –b. If applied by mechanical dilution the following K-potencies are used in homeopathic practice: 30 K 200 K MK 10M K 50M K CMK 30 times 1:100 one glass method 200 times 1:100 one glass method 1000 times 1:100 one glass method 10,000 times 1:100 one glass method 50,000 times 1:100 one glass method 100.000 times 1:100 one glass method Inclusion of this manufacturing method in the European Pharmacopoeia is still under discussion. 33. LM – potencies: D: Fr: It: NL: LM-Potenzen Dilutions LM Diluizioni LM LM-potenties 15 LM-Potencies are pillules prepared by potentisation of 1 part of a concentrated preparation, starting from a C3 trituration, with 50000 parts of a vehicle, or solutions of such pillules in ethanol (15 per cent (m/m). Manufacturing method described in the German Homeopathic Pharmacopoeia (HAB), method 17. Starts with LM1 (one time 1:50,000) to the highest LM30 (30 times 1: 50,000). Originally described by Hahnemann. The term “1:50000” do not correspond to the real concentration which is nearly D15, it describes only the last step of the procedure. The way of application, the dosage and the repetition is different from the application of Dand C-potencies. Even though these potencies are high potencies they can be administered daily. Traditionally, the following LM potencies are used in homeopathic practice: from LM1 to LM12, and then LM18, LM24 and LM30. But they are also used in raising potencies from LM1 up to LM30. Reference: German Homeopathic Pharmacopoeia, European Pharmacopoeia, monograph 1038, (2371) German comment: Q-potency is not accepted as the synonym for LM-potency, because the manufacturing procedure is different (see result of the discussion in the HMM WP and the new version of the monograph 1038) 34. Lithotherapy: Synonym: Dechelating lithotherapy. D: Fr: It: NL: Lithotherapie Lithothérapie déchélatrice Litoterapia Lithotherapie The use of homeopathic preparations (usually as D8 dilutions) derived from natural rocks and minerals. Part of the French and Belgian homeopathic tradition. The prescription is not based on the simile-principle. 35. Materia medica: D: Fr: It: NL : Materia Matière Materia Materia Medica médicale medica medica The term Materia Medica is often used to reference the total sum of homeopathic medicines and the symptoms and conditions for which they may be prescribed. In homeopathy, Materia medica are often named after the author: Materia medica of Boericke, Materia medica of Voisin etc. 36. Mixed Potency Drugs: D: F: Potenzakkorde Médicaments à dynamisations mixtes 16 It : NL: Rimedi a diluzioni miste Potentie-akkoord Combinations of two or more different potencies of one homeopathic preparation incorporated into one dosage form. The used potencies range from D4/D6 up to D1000. Frist described by E.Cahis (Spain 1855-1934), later further developed (among others) by H. Reckeweg , founder of the Homotoxicology (German 1905-1985). Mainly part of the German homeopathic tradition. For example: Arnica montana D6-D12-D30-D200 oral drops. 37. Mechanical dilution process: Synonym: Continuous flux dilution, Fincke-potentization D: AUS: Fr: It: NL: Fluxionspotenzen Fincke-Technik Processo di diluizione meccanico Continuous flux verdunningen Method of performing a process of serial dilution in which there are no clearly defined dilution stages and the potentisation is done through the continuous supply and the turbulence of water. Final (high) potencies as a result of this method are called K-potencies. German Comment: We want to delete this point because it is not described in an official pharmacopoeia. Concerning the term “K-potencies”: is it the right term? (compare Korsakovian potencies) 38. Nosode: D: Fr: It: NL: Nosoden Nosodes Nosode Nosode Homeopathic preparations made from products of human or animal disease processes, from pathogens or their metabolic products, from the decomposition products of animal organs, or from cultured micro-organisms. Reference: Points to consider on Safety of Homeopathic medicinal products from Biological origin. (July 2007) 39. Organotherapy Synonyms: sarcode-therapy, sarcodes D: Organotherapie 17 Fr: It: NL: Organothérapie Organoterapia Organotherapie Treatment with a potentisated extract of a healthy organ obtained from a healthy animal (bovine cattle, sheep or swine), corresponding to the patients diseased organ. The prescription is based on the idea to support the sick organ of the patient by the preparation of the same organ of animal origin. Not based on the law of similarity. These products usually are used in the following dilutions: C4/4CH (sometimes C5/5CH), C7/7CH and C9/9CH. ) Part of the French and Belgian homeopathic tradition. 40. Polychrests D: Fr: It: NL: Polychreste Polychreste Policresti Polychresten Homeopathic drugs which are proved intensively with a wide spectrum of symptoms including symptoms of mind and all parts of the body. There is a long experience with them in homeopathic practice and they are frequently used for the treatment of a wide range of diseases, especially chronic diseases. 41. Repertory: D: Fr: It: NL: Repertorium Répertoire Repertorio omeopatico Repertorium A homeopathic repertory is an extensive and comprehensive index of symptoms and their remedies, including systematic cross reference of symptoms and disorders related to the homeopathic drugs in whose therapeutic repertoire they occur. One of the first classic handbooks was Kent’s Repertory (which included 624 different homeopathic remedies), compiled by the American homeopathy James Tyler Kent (1849-1916). Since then, these repertories have been extensively revised, corrected and updated through several editions and incorporating material from materia medica and many other repertories. 42. Schüssler Salts: D: AUS: Fr: It: NL: Schüßler-Salze Schüßler-Salze Sels de Schüssler Sali di Schüssler Schüssler zouten 18 Therapeutic method used to treat postulated mineral salt deficiencies or to treat an imbalance of inorganic salts using homeopathic preparations of originally 12 salts in low potencies (D6) Developed by WH Schüssler (D 1821-1895). Also called: “Biochemic salts” Later another 12 salts were added. 43. Similia principle / Simile principle Synonyms: Law of Similars, Similia-rule, “Simila similibus curentur” D: Fr: It: NL: Simile-Prinzip Loi de similitude / (Principe de similitude) Legge della similitudine Similia-principe, Simila Wet The underlying principle of homeopathy that substances may be used therapeutically to treat disorders similar to that which they will themselves induce in a healthy subject. 44. Trituration: D: Fr: It: NL: Verreibungen Trituration Triturazioni Verwrijvingen Homeopathic manufacturing method as potentisation process by grinding together with lactose solid raw material (e.g. of mineral origin), mother tinctures, solutions and their dilutions as well as mixtures with lactose monohydrate as vehicle. Reference: European Pharmacopoeia, monograph 2371 Germany proposes the following additional terms, to be elaborated: Anthroposophic medicines Drug picture Drainage Homeopathic anamnesis (Homeopathic) drug interaction (Homeopathic drug) proving Homotoxicology Head-to-feet-scheme Isopathy Constitutional remedy Miasm Modalities Repertorisation 19 Liquid preparations for cutaneous application Homeopathic Ointments Suppositories Eye-drops Ear-drops Co-potentised mixtures Vicesimal potencies proposal from [UK] to include a separate definition for “Succussion” From the manufacturing point of view and in order to maintain batch to batch homogeneity I propose it could be defined as follows: The process of agitating a freshly prepared diluted solution over a fixed period of time by striking its container against a hard but elastic object by a fixed amplitude and frequency. 3. References: European Pharmacopoeia 7th edition Published in accordance with the Convention of the Elaboration of a European Pharmacopoeia (European Treaty series no. 50) Published by the Directorate for the Quality of Medicine & Health Care of the Council of Europe (EDQM), Strasbourg. Homöopathisches Arzneibuch 2008 (HAB) Amtliche Ausgabe Deutscher Apotheker Verlag Stuttgart Pharmacopée Française Xème édition Homeopathic Thesaurus. Keyterm to be used in homeopathy (Tree structure and alphabetical list; English, German, French, Italian) Third multilingual edition 2007 European Committee for Homeopathy (ECH) Points to consider on Safety of Homeopathic medicinal products from Biological origin. (July 2007) 20