HOMEOPATHIC MEDICINAL PRODUCT WORKING GROUP (HMPWG) POINTS TO CONSIDER ON THE JUSTIFICATION OF HOMEOPATHIC USE

Transcription

1 HOMEOPATHIC MEDICINAL PRODUCT WORKING GROUP (HMPWG) POINTS TO CONSIDER ON THE JUSTIFICATION OF HOMEOPATHIC USE DISCUSSION IN THE SUBGROUP March-April 2009 DISCUSSION IN THE HMPWG 30 April 2009 ADOPTION FOR TRANSMISSION TO HMA for release for consultation 1 June 2009 DEADLINE FOR COMMENTS 1 October 2009 DISCUSSION IN THE SUBGROUP October 2009 DISCUSSION IN THE HMPWG FOR ADOPTION 8 December 2009 ADOPTION BY THE HMPWG FOR TRANSMISSION TO April 2010 THE HMA ADOPTION BY THE HMA 10 May 2010

2 POINTS TO CONSIDER ON THE JUSTIFICATION OF HOMEOPATHIC USE HOMEOPATHIC MEDICINAL PRODUCT REGISTRATION APPLICATIONS DIRECTIVE 2001/83/EC (AS AMENDED) ART. 14 SIMPLIFIED PROCEDURE : This consists of a well developed rationale for the justification of the homeopathic use of the stock(s) and its/ their dilution(s), based on the documentation that has to be supplied separately in the following sections. The submitted documents (monographs, materia medica.) should be made available in the original language with an English translation if requested by the competent authority. I. ACTIVE SUBSTANCE (NAME) For a homeopathic combination containing more than one active substance, the information requested for part I should be provided in its entirety for each active substance. I.1. Nomenclature (name) 1 : Scientific name or other name of the homeopathic stock, given in accordance with an official pharmacopoeia monograph if available. When homeopathic synonyms are used these should be justified by literature presented in section III.I.1. 1 Must be in concordance with data submitted in module3 2

3 I.2. Reference monograph for manufacturing method of stock or homeopathic preparation (name): The homeopathic manufacturing procedure described by the European Pharmacopoeia, or in absence thereof in a pharmacopoeia officially used in a Member State, should be stated and the monograph provided in section III.I.2. If the homeopathic stock is described in the European Pharmacopoeia or in absence thereof in a pharmacopoeia officially used in a Member State, the reference to the relevant pharmacopoeia monograph should be stated and the monograph provided in section III.I.2. I.3. Materia Medica (name): If available, the information should be provided in this section in tabulated format as follows: Title of the Materia Medica/ edition/ publisher/ date Paragraph and page number Detailed texts for each entry mentioned in the table should be included in annex III.I.3. I.4. Homeopathic proving(s) (name): If available, and, in any case if the homeopathic use of the stock and its/their dilution(s) is not clearly justified in the other sections, information regarding the type of method used for the proving (e.g. provings in healthy subjects, double-blind provings in healthy subjects) should be provided. The information should be presented in tabulated format as follows: Date (of publication) Number of provers Number of symptoms Administered preparation/dilution Posology/ route of administration Duration Method Detailed texts for each proving mentioned in the table should be included in annex III.I.4. 3

4 I.5. Other bibliographical data (name): Additional bibliographical data could be valuable to consolidate the registration dossier, if available, but should certainly be given in the absence of relevant and conclusive information in the previous sections of the document. The relevant bibliographical data could, for example, consist of classical homeopathic texts and documented homeopathic traditions, other literature references, recent publications (e.g. results of experimental research if available), symptomatology of intoxication related to the stock and/or the raw material, pathological data, etc. The relevant information (with reference to the source of data and search engine used) should be presented in tabulated format as follows: Category of references Search engine used (if applicable) Reference P: Non official pharmacopoeia (EU/ outside EU) H: documented homeopathic traditions L: other literature references R: recent publications (e.g. results of experimental research) T: toxicological data related to the stock and or the raw material F: pathological data D: monographs of Commission D C: monographs of Commission C (only if the active substance is produced according to a homeopathic manufacturing method described in the Ph. Eur. or in another pharmacopoeia officially used in a Member state ) and other relevant documentation Detailed texts (in which the relevant data are highlighted) for each entry in the table should be included in section III.I.5. 4

5 II. Detailed references The submitted documents (monographs, materia medica.) should be made available in the original language with an English translation, if requested by the competent authority. II.I. Detailed references for each drug substance II.I.1. Nomenclature II.I.2. Reference monograph for manufacturing method of stock or homeopathic preparation II.I.3. Materia Medica II.I.4. Homeopathic provings II.I.5. Other bibliographical data II.II. Detailed references for the homeopathic combination (cross-references to section III.I. are acceptable) II.II.1. Rationale for the combination II.II.2. History of the formula II.II.3. Proving(s) established with the homeopathic combination. 5