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Commission Implementing Regulation (EU) 2021/1281 laying down rules for the application of Regulation (EU) 2019/6 as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products.

País/Territorio
Unión Europea
Tipo de documento
Reglamento
Fecha
2021
Fuente
FAO, FAOLEX
Fuente original
Official Journal of the European Union L 279, 3 August 2021, pp. 15-29.
Materia
Ganado, Pesca
Palabra clave
Autorización/permiso Negocios/industria/corporaciones Fortalecimiento de la capacidad Certificación Recopilación de datos/informes Inspección Evaluación/manejo de riesgos Medicamentos Enfermedades de los peces Sanidad animal
Área geográphica
Pays de l'Union Européenne
Entry into force notes
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union and shall apply from 28 January 2022.
Resumen

This Regulation lays down the requirements for the marketing authorisation holder’s pharmacovigilance system established and maintained in accordance with Article 77(1) of Regulation (EU) 2019/6, including the establishment and implementation of an adequate and effective quality management system for the performance of their pharmacovigilance activities; setting up and maintaining a document management system to keep all documents related to pharmacovigilance activities; training all personnel involved in the performance of pharmacovigilance activities; performing audits of the pharmacovigilance system at regular risk-based intervals to ensure that it complies with the requirements set out in this Regulation; and managing corrective and preventive actions, to mitigate any deviations detected in audits, daily operational work and findings from inspections. This Regulation provides for the establishment of a record management system for receiving, recording, collating and assessing information on adverse events and for recording safety information. Furthermore, marketing authorisation holders shall record adverse events in the Union Pharmacovigilance database. Marketing authorisation holders shall ensure that the pharmacovigilance system includes a risk management system to take appropriate action to minimise identified risks, when necessary. The content and structure of the pharmacovigilance system master file are set out in Article 22. Marketing authorisation holders shall be prepared for inspections of their pharmacovigilance system and the corresponding pharmacovigilance system master file.

Texto completo
Inglés
Página web
eur-lex.europa.eu

Referencias - Legislación

Implementa

Regulation (EU) 2019/6 of the European Parliament and of the Council on veterinary medicinal products and repealing Directive 2001/82/EC.

Legislación | Unión Europea | 2018 (2022)

Palabra clave: Acuicultura, Animales acuáticos, Enfermedades de los peces, Medicamentos, Sanidad animal, Legislación básica, Comercio interior, Comercio internacional, Autorización/permiso, Acceso-a-la-información, Inspección, Infracciones/sanciones, Negocios/industria/corporaciones

Fuente: FAO, FAOLEX

Implementado por

Loi sur les médicaments vétérinaires.

Legislación | Bélgica | 2022

Palabra clave: Sanidad animal, Autorización/permiso, Legislación básica, Plagas/enfermedades, Inspección, Institución, Salud pública, Evaluación/manejo de riesgos, Medicamentos

Fuente: FAO, FAOLEX