DIRECTIVA 92/27/CEE DEL CONSEJO de 31 de marzo de 1992 relativa al etiquetado y al prospecto de los medicamentos de uso humano
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DIRECTIVA 92/27/CEE DEL CONSEJO de 31 de marzo de 1992 relativa al etiquetado y al prospecto de los medicamentos de uso humano
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Afectaciones
IMPLEMENTADA por
- REAL DECRETO 767/1993, de 21 de Mayo, por el que se regula la Evaluacion, autorizacion, registro y Condiciones de Dispensacion de Especialidades farmaceuticas y Otros medicamentos de Uso humano fabricados industrialmente.
- REAL DECRETO 2236/1993, de 17 de Diciembre, por el que se regula el Etiquetado y el Prospecto de los Medicamentos de Uso humano.
Documentos citados
- Council Directive 89/381/EEC of 14 June 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products and laying down special provisions for medicinal products derived from human blood or human plasma
- Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets
- Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products
- Council Directive 92/26/EEC of 31 March 1992 concerning the classification for the supply of medicinal products for human use
- Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products