Veterinary Medicinal Products Regulations, 2004 (L.N. 469 of 2004). País/Territorio Malta Tipo de documento Reglamento Fecha 2004 Fuente FAO, FAOLEX Materia Ganado Palabra clave Sanidad animal Medicamentos Autorización/permiso Recopilación de datos/informes Acceso-a-la-información Inspección Comercio interior Comercio internacional Infracciones/sanciones Área geográphica Europa, Europa y Central Asia, Países de la Unión Europea, Mediterráneo, Europa Meridional Resumen In compliance with the European Community code relating to veterinary medicinal products laid down in Directive 2001/82/EC, the present Regulations establish particular provisions applicable to veterinary medicinal products destined to be placed on the market in the form of medicinal products, readymade veterinary medicinal products or premixes for medicated feedingstuffs. Title III (regs. 5-37) deals with marketing, for which an authorization issued by the Veterinary Services is compulsory. Title IV (regs. 38-50) concerns manufacture and imports. Title V (regs. 51-57) deals with labelling and package insert. Title VI (regs. 58-64) applies to the possession, wholesale distribution and dispensing of veterinary medicinal products. Title VII (regs. 65-71) provides for the setting up of a pharmocovigilance system. Title VIII (regs. 72-79) regards the inspections to be carried out by the Veterinary Services with a view to ensuring compliance with these Regulations, and sets out the sanctions to be applied in case of infringement. The Schedule attached concerns the requirements and analytical protocol, safety tests, pre-clinical and clinical for tests of veterinary medicinal products. Texto completo Inglés Página web www.doi.gov.mt Referencias - Legislación Implementa Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products. Legislación | Unión Europea | 2001 Palabra clave: Legislación básica, Sanidad animal, Medicamentos, Autorización/permiso, Recopilación de datos/informes, Acceso-a-la-información, Inspección, Comercio interior, Comercio internacional, Infracciones/sanciones Fuente: FAO, FAOLEX Implementado por Veterinary Medicinal Products (Amendment) (No. 2) Regulations (L.N. 360 of 2009). Legislación | Malta | 2009 Palabra clave: Medicamentos, Sanidad animal, Inspección Fuente: FAO, FAOLEX Enmendado porr Veterinary Medicinal Products (Amendment) (No. 2) Regulations, 2009 (L.N. 360 of 2009). Legislación | Malta | 2009 Palabra clave: Medicamentos, Sanidad animal, Normas, Inspección Fuente: FAO, FAOLEX Veterinary Medicinal Products (Amendment) Regulations, 2009 (L.N. 23 of 2009). Legislación | Malta | 2009 Palabra clave: Sanidad animal, Medicamentos, Autorización/permiso, Comercio interior, Comercio internacional Fuente: FAO, FAOLEX Veterinary Medicinal Products (Amendment) Regulations, 2006 (L.N. 82 of 2006). Legislación | Malta | 2006 Palabra clave: Sanidad animal, Medicamentos, Autorización/permiso, Comercio interior, Comercio internacional Fuente: FAO, FAOLEX Veterinary Medicinal Products (Amendment No. 2) Regulations, 2021 (L.N. 470 of 2021). Legislación | Malta | 2021 Palabra clave: Sanidad animal, Medicamentos, Infracciones/sanciones Fuente: FAO, FAOLEX Veterinary Medicinal Products (Amendment) Regulations, 2021 (L.N. 179 of 2021). Legislación | Malta | 2021 Palabra clave: Sanidad animal, Medicamentos, Autorización/permiso, Recopilación de datos/informes, Acceso-a-la-información, Inspección, Comercio interior, Comercio internacional, Infracciones/sanciones Fuente: FAO, FAOLEX