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Medicines (Data Sheets for Veterinary Drugs) Regulations 2000 (S.I. No. 2386 of 2000).

País/Territorio
Reino Unido
Tipo de documento
Reglamento
Fecha
2000
Fuente
FAO, FAOLEX
Materia
Ganado
Palabra clave
Sanidad animal Medicamentos Recopilación de datos/informes
Área geográphica
Islas del Océano Atlántico, Europa, Europa y Central Asia, Atlántico Norte, Mar del Norte, Atlántico Nordeste, Europa Septentrional
Entry into force notes
These Regulations enter into force on 1 October, 2000.
Resumen

These Regulations prescribe the form of data sheets (reg. 2) and the particulars to be contained in them (regs. 3 to 6 and the Schedule) which the holder of a product licence or marketing authorization is required under the Medicines Act 1968 to send or deliver to practitioners in connection with any advertisement or representation.. These Regulations enable documents which are summaries of the product characteristics to which a marketing authorization relates, containing the particulars prescribed by Article 5a of Council Directive 81/851/EC on the approximation of the laws of the Member States relating to veterinary medicinal products, to be used as data sheets for the purposes of advertisements and representations directed to practitioners in section 96 of the Medicines Act 1968. A "marketing authorization" is defined as one to which the Marketing authorizations for Veterinary Medicinal Products Regulations 1994 (S.I. 1994/3142) apply, being one which is granted pursuant to Council Directive 81/851/EC or one pursuant to Council Regulation (EC) No. 2309/93 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products.

Texto completo
Inglés
Página web
www.opsi.gov.uk

Referencias - Legislación

Implementa

Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products.

Legislación | Unión Europea | 1981

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

Fuente: FAO, FAOLEX

Revocado por

Veterinary Medicines Regulations 2005 (S.I. No. 2745 of 2005).

Legislación | Reino Unido | 2005

Palabra clave: Sanidad animal, Medicamentos, Clasificación/declasificación, Inspección, Alimentos para animales/piensos

Fuente: FAO, FAOLEX