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Legislative Decree No. 71 implementing Directives 2000/37/EC and 2001/82/EC concerning veterinary medicinal products.

País/Territorio
Italia
Tipo de documento
Legislación
Fecha
2003
Fuente
FAO, FAOLEX
Fuente original
Gazzetta Ufficiale della Repubblica Italiana No. 87, 14 April 2003.
Materia
Ganado
Palabra clave
Sanidad animal Medicamentos
Área geográphica
Alpes, Europa, Europa y Central Asia, Países de la Unión Europea, Mediterráneo, Europa Meridional
Resumen

In implementation of particular provisions laid down in Directives 2000/37/EC and 2001/82/EC, this Legislative Decree amends and supplements Legislative Decree No. 119 of 1992 in matter of veterinary drugs. Chapter IV bis shall be inserted after Chapter IV. The new provisions regard the Advisory Commission on Veterinary Drugs, which shall operate under the Ministry of Health. Further, article 26 bis shall be replaced by the text contained in article 3 hereto dealing with the national pharmacovigilance system, which is charged with the collection and valuation, on a scientific basis, of all relevant information. On the other hand, the Regions as well as the Autonomous Provinces shall contribute to the pharmacovigilance system either by setting up their own regional pharmacovigilance centres or by entrusting the competences in question to the regional veterinary services. The Annex attached contains the model of the form to be filled in and submitted to the competent authorities in case any adverse reaction occurs.

Texto completo
Italiano
Página web
www.comune.jesi.an.it

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

Commission Directive 2000/37/EC amending Chapter VIa 'Pharmacovigilance' of Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products.

Legislación | Unión Europea | 2000

Palabra clave: Sanidad animal, Medicamentos, Autorización/permiso, Acceso-a-la-información, Recopilación de datos/informes, Comercio interior, Comercio internacional

Fuente: FAO, FAOLEX

Enmienda

Legislative Decree No. 119 implementing Directives Nos. 81/851/CEE, No. 81/852/CEE, No. 87/20/CEE and No. 90/676/CEE on veterinary drugs.

Legislación | Italia | 1992 (1997)

Palabra clave: Sanidad animal, Medicamentos, Autorización/permiso, Comercio internacional

Fuente: FAO, FAOLEX