Real Decreto por el que se regulan los Productos Sanitarios (Real Decreto 1591/2009, de 16 de octubre)

Documentos citados

• Ley General de Publicidad (Ley 34/1988, de 11 de noviembre)
• Ley de régimen jurídico de las Administraciones Públicas y del Procedimiento Administrativo Común (Ley 30/1992, de 26 de noviembre) - Artículos 116, 117
• Constitución Española de 1978 - Artículo 149
• Ley General de Sanidad (Ley 14/1986, de 25 de abril) - Artículos 27, 100, 102
• Ley Orgánica de Protección de Datos de Carácter Personal (Ley Orgánica 15/1999, de 13 de diciembre)



Ver todas las citas

• Ley de Garantías y Uso Racional de los Medicamentos y Productos Sanitarios (Ley 29/2006, de 26 de julio) - Artículos 3, 60, 78
• REAL DECRETO 414/1996, de 1 de Marzo, </strong>por el que<strong> se regula los Productos sanitarios.
• ORDEN SCO/3603/2003, de 18 de diciembre, </strong>por la que<strong> se crean los Registros Nacionales de Implantes.
• REAL DECRETO 1836/1999, de 3 de diciembre, </strong>por el que se aprueba<strong> el Reglamento sobre instalaciones nucleares y radiactivas.
• Real Decreto 1407/1992, de 20 de noviembre, </strong>por el que<strong> se regulan las condiciones para la Comercializacion y libre circulación intracomunitaria de los equipos de Proteccion individual.
• Real Decreto por el que se regulan los Ensayos Clínicos con Medicamentos (Real Decreto 223/2004, de 6 de febrero) - Artículo 8
• Reglamento sobre Protección Sanitaria contra Radiaciones Ionizantes (Real Decreto 783/2001, de 6 de julio)
• Real Decreto 1132/1990, de 14 de septiembre, </strong>por el que<strong> se establecen medidas fundamentales de protección radiológica de las personas sometidas a exámenes y tratamientos médicos.
• Real Decreto sobre Productos Sanitarios para Diagnóstico 'In Vitro' (Real Decreto 1662/2000, de 29 de septiembre)
• Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations
• Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
• Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances
• Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market
• Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (Text with EEA relevance)
• Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance)Text with EEA relevance
• Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance)Text with EEA relevance
• Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use Text with EEA relevance
• Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (Text with EEA relevance)
• Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC Text with EEA relevance
• Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (Text with EEA relevance)
• Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption
• Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance)
• Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies
• Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• 93/465/EEC: Council Decision of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization directives
• Council Regulation (EEC) No 339/93 of 8 February 1993 on checks for conformity with the rules on product safety in the case of products imported from third countries
• Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC
• Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Text with EEA relevance)
• Real Decreto por el que se aprueba el Reglamento sobre instalación y utilización de aparatos de rayos X con fines de diagnóstico médico. (Real Decreto 1085/2009, de 3 de julio)