La réglementation dédiée à l’évaluation des interventions non médicamenteuses (INM) (notice n° 654185)
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| fixed length control field | 02979cam a2200289 4500500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20250121190156.0 |
| 041 ## - LANGUAGE CODE | |
| Language code of text/sound track or separate title | fre |
| 042 ## - AUTHENTICATION CODE | |
| Authentication code | dc |
| 100 10 - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Bardie, Yannick |
| Relator term | author |
| 245 00 - TITLE STATEMENT | |
| Title | La réglementation dédiée à l’évaluation des interventions non médicamenteuses (INM) |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Date of publication, distribution, etc. | 2018.<br/> |
| 500 ## - GENERAL NOTE | |
| General note | 46 |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | La réglementation européenne stipule que tout traitement ayant une finalité médicale, c’est-à-dire présenté comme ayant des vertus thérapeutiques ou prophylactiques, doit avoir fait la preuve de son innocuité, de sa tolérance, de son efficacité, de sa performance, et de son acceptabilité par le patient. Cette preuve doit être scientifiquement robuste et documentée. Il en découle pour les produits ayant des indications, des revendications ou simplement des allégations de santé, la nécessité de présenter aux autorités compétentes un dossier d’homologation, d’autocertification, d’autorisation de mise sur le marché, de marquage CE selon les types d’Intervention non médicamenteuse (INM), avant de pouvoir être distribués et commercialisés. Pour autant, il est manifeste que la Loi ou des directives ne s’appliquent pas de façon homogène selon les types d’INM. Cet article apporte un éclairage méthodologique et réglementaire, afin de permettre au lecteur de s’orienter dans ce maquis hétérogène où le patient, devient un acteur voire un auteur central, et ne se comporte plus comme un traditionnel patient-passif. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | The European regulation stipulates that any treatment having a medical purpose, i.e. presented as having therapeutic or prophylactic virtues, must have proven its safety, its tolerance, its efficiency, its performance, and its acceptability by the patient. This evidence must be scientifically robust and documented. It follows that for products with indications, claims or simply health claims, the need to submit to the competent authorities a dossier for approval, self-certification, marketing authorization, CE marking depending on the types of Non-Pharmacological Intervention (NPI), before they can be distributed and marketed. However, it is clear that the Act or directives do not apply homogeneously according to the types of NPIs. This article provides a methodological and regulatory insight, in order to allow the reader to orient himself in this heterogeneous domain where the patient becomes an actor or even a central author, and no longer behaves like a traditional patient-passive. |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | Usage |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | Evaluation |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | Réglementation |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | Intervention non médicamenteuse |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | INM |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | Use |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | Regulation |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | Evaluation |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | NPIs |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | Non-pharmacological intervention |
| 786 0# - DATA SOURCE ENTRY | |
| Note | Hegel | 1 | 1 | 2018-01-01 | p. 28-34 | 2269-0530 |
| 856 41 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://shs.cairn.info/revue-hegel-2018-1-page-28?lang=fr&redirect-ssocas=7080">https://shs.cairn.info/revue-hegel-2018-1-page-28?lang=fr&redirect-ssocas=7080</a> |
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