Law on veterinary medicinal products. País/Territorio Croacia Tipo de documento Legislación Fecha 2008 Fuente FAO, FAOLEX Materia Ganado Palabra clave Sanidad animal Legislación básica Medicamentos Autorización/permiso Transporte/depósito Procesamiento/manipulación Salud pública Residuos Monitoreo Inspección Comercio interior Comercio internacional Infracciones/sanciones Vacunación Área geográphica Europa, Europa y Central Asia, Países de la Unión Europea, Mediterráneo, Europa Meridional Entry into force notes This Law enters into force on 1 February 2009, except for the certain paragraphs of articles 9, 37, 42, 61, 66 and 80 which shall enter into force on the day of accession of the Republic of Croatia to the European Union. Resumen This Law regulates and establishes the necessary procedure for testing and marketing, production, labelling, wholesale and retail trade, pharmacovigilance, quality control, advertising and surveillance of all recognized veterinary medicinal products. This Law sets out rules and methods aimed at ensuring the quality, safety and effectiveness of such products, intended for the protection of animal health and thus the protection of human health from veterinary medicinal product residues that can be found in food of animal origin and in animal feed. Veterinary medicinal products are divided into two different types: veterinary medicinal products issued by veterinary prescription; and those that can be issued without such prescription. The conditions for classifying, prescribing and issuing of veterinary medicinal products shall be laid down by the national Minister in charge of Agriculture, Fisheries and Rural Development. This national competent authority shall also manage all activities and shall carry out pharmacovigilance monitoring task and other inspection related affairs. This Law regulates and establishes the necessary procedure for testing and marketing, production, labelling, wholesale and retail trade, pharmacovigilance, quality control, advertising and surveillance of all recognized veterinary medicinal products. This Law sets out rules and methods aimed at ensuring the quality, safety and effectiveness of such products, intended for the protection of animal health and thus the protection of human health from veterinary medicinal product residues that can be found in food of animal origin and in animal feed. Veterinary medicinal products are divided into two different types: veterinary medicinal products issued by veterinary prescription; and those that can be issued without such prescription. The conditions for classifying, prescribing and issuing of veterinary medicinal products shall be laid down by the national Minister in charge of Agriculture, Fisheries and Rural Development. This national competent authority shall also manage all activities and shall carry out pharmacovigilance monitoring task and other inspection related affairs. Texto completo Croata Página web www.nn.hr Referencias - Legislación Revoca Law on Veterinary Drugs and Veterinary Medicinal Products. Legislación | Croacia | 1998 Palabra clave: Medicamentos, Transporte/depósito, Sanidad animal Fuente: FAO, FAOLEX Implementado por Regulation on the Authorisation of Official and Reference Laboratories in the Implementation of Veterinary Services. Legislación | Croacia | 2010 Palabra clave: Sanidad animal, Recopilación de datos/informes, Inspección, Medicamentos, Autorización/permiso Fuente: FAO, FAOLEX Regulation on veterinary medicinal products issued without a veterinary prescription and applicable to animals intended for human consumption. Legislación | Croacia | 2009 Palabra clave: Sanidad animal, Medicamentos, Autorización/permiso, Cuestiones de procedimiento, Recopilación de datos/informes Fuente: FAO, FAOLEX Regulation on pharmacovigilance for veterinary medicinal products. Legislación | Croacia | 2009 Palabra clave: Sanidad animal, Medicamentos, Recopilación de datos/informes Fuente: FAO, FAOLEX Regulation on veterinary medicinal products. Legislación | Croacia | 2009 Palabra clave: Sanidad animal, Medicamentos, Autorización/permiso, Envasado/etiquetado, Inspección, Comercio interior, Comercio internacional, Monitoreo Fuente: FAO, FAOLEX Regulation on the list of active substances necessary for the treatment of equidae. Legislación | Croacia | 2009 Palabra clave: Control de calidad de los alimentos/inocuidad de los alimentos, Medicamentos, Equino, Sanidad animal, Plagas/enfermedades, Clasificación/declasificación, Protección de los animales, Límite máximo de residuos Fuente: FAO, FAOLEX Regulation on modifications to the marketing authorization for veterinary medicinal products. Legislación | Croacia | 2010 Palabra clave: Sanidad animal, Medicamentos, Autorización/permiso, Cuestiones de procedimiento, Comercio interior Fuente: FAO, FAOLEX Regulation on the manner of advertising veterinary medicinal products. Legislación | Croacia | 2009 Palabra clave: Sanidad animal, Medicamentos, Cuestiones de procedimiento Fuente: FAO, FAOLEX Regulation on information on veterinary medicinal products through rapid alert systems. Legislación | Croacia | 2015 Palabra clave: Sanidad animal, Medicamentos, Sistema de alerta temprana, Cuestiones de procedimiento, Clasificación/declasificación Fuente: FAO, FAOLEX Enmendado porr Law amending the Law on veterinary medicinal products. Legislación | Croacia | 2013 Palabra clave: Sanidad animal, Medicamentos, Recopilación de datos/informes, Monitoreo, Infracciones/sanciones Fuente: FAO, FAOLEX Law amending the Law on veterinary medicinal products. Legislación | Croacia | 2015 Palabra clave: Sanidad animal, Medicamentos, Autorización/permiso, Infracciones/sanciones Fuente: FAO, FAOLEX Law amending the Law on veterinary medicinal products. Legislación | Croacia | 2019 Palabra clave: Sanidad animal, Medicamentos, Procesamiento/manipulación, Autorización/permiso, Infracciones/sanciones Fuente: FAO, FAOLEX