Zoom sur le cadre juridique des pharmacies vétérinaires

Des dispositions complexes s’avèrent parfois nécessaires pour dispenser des médicaments dans le cadre de la médecine vétérinaire. Car la même rigueur est appliquée autant à la médecine humaine qu’à la médecine vétérinaire. exemple : distrihorse33.

Des produits bien réglementés

Le développement de médicaments pour les animaux dédiés à la médecine vétérinaire est encadré par une série d’études portant sur l’efficacité et la sécurité, comme cela se fait également pour les humains. Ces démarches préliminaires contribuent à mettre au point le procédé de contrôle et de fabrication : des dispositions élémentaires qui assurent de la qualité de la production industrielle.

Il en va de même pour la mise en marché, qui nécessite d’obtenir l’autorisation administrative qui s’impose, en conformité avec la réglementation.

Quant aux étapes de production et de distribution en gros, les entreprises qui sont mandatées pour compléter ces phases de commercialisation s’avèrent elles-mêmes soumises à des contrôles et doivent se plier à un processus d’autorisations à des degrés variables. La catégorie du produit influe sur les processus d’autorisation. Il peut s’agir, par exemple, de biocides, de réactifs servant aux analyses vétérinaires, de produits phytopharmaceutiques, de même que de matières premières dédiées à l’usage pharmaceutique.

Les végétaux appelés à jouer des rôles prépondérants

Les végétaux consistent en des matières qui représentent une source importante pour les diverses catégories de produits de la médecine vétérinaire. Des points de repères ont été balisés spécifiquement, dans le cas des végétaux, afin de contribuer à faciliter les démarches d’entreprises concernées par les produits relevant de la réglementation concernant la médecine vétérinaire.

Les végétaux seront de plus en plus appelés à jouer un rôle prépondérant dans la médecine vétérinaire. En effet, avec le phénomène répandu de résistance à certains médicaments tels que les antiparasitaires et les antibiotiques, le recours à des préparations comportant des végétaux devrait s’accroître, suite à des politiques de réduction d’usage de types spécifiques de médicaments. Le développement de médecines vétérinaires devrait également contribuer à la classification de davantage de produits de végétaux pour la médecine vétérinaire.

Les démarches à compléter pour obtenir classification d’un produit

L’agence Anses ANMV exige que plusieurs démarches soient complétées afin d’obtenir la classification d’un produit pour la médecine vétérinaire :

  • ÉVALUATION : Les produits candidats sont soumis à une évaluation sur la base de critères correspondant aux diverses catégories de produits;
  • INTÉGRATION À UN PROCESSUS : Les produits candidats sont ensuite intégrés dans un processus d’autorisation, notamment l’enregistrement de médicaments homéopathiques, la demande d’autorisation ATU (autorisation temporaire d’utilisation), de même que la demande d’autorisation d’importation;
  • CONFORMITÉ DU CIRCUIT DE PRODUCTION ET DISTRIBUTION : L’agence examine de plus près ce qui a été prévu en termes de circuit de production, et sous la base de quels mécanismes et systèmes s’opère la distribution en gros et au détail . De plus, les établissements pharmaceutiques et leurs ayants droit (vétérinaires, pharmaciens, groupes d’éleveurs, etc.) doivent être eux-mêmes conformes aux règles prévues au Code de la santé publique;
  • TRAITEMENT DES INFRACTIONS : L’agence Anses-ANMV dispose de mesures pouvant être activées en cas d’infraction et de non-conformité aux diverses règles. Les pouvoirs de police sanitaire incluent la mise en œuvre de plusieurs dispositifs, qu’il s’agisse d’interdictions de production et distribution, ou encore de sanctions financières, allant même jusqu’à transmettre le dossier à des tribunaux judiciaires.
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