Virtual Office
Vigilance
How arrive?
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Industria
12th March 2013 -
The Spanish Agency of Medicines and Medical Devices sets up a new software application that allows marketing authorization holders the telematic management of Summary of Product Characteristics and Patient Information Leaflets
The Spanish Agency of Medicines and Medical Devices announces a new application for submission of Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL) by the Marketing Authorization Holders.
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La AEMPS
22nd February 2013 -
Submission of the development safety update report (DSUR) to the AEMPS via the portal ECM and non acceptance of compressed files
The Spanish Agency of Medicines and Medical Devices (AEMPS) recommends the submission of the Development Safety Update Report (DSUR) to the AEMPS via the Portal ECM.
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Industria
10th December 2012 -
Instruction about the implentation procedure of the european decision regarding the marketing authorisations for all veterinary medicinal products containing active substances belonging to the class of flukicides which are intended for use in ruminants producing milk for human consumption
On the 19th of November 2012 the European Commission adopted the executive Decision C (2012) 8604, based on the Article 35 of the Directive 2001/82/CE of the European Parliament and the Council regarding the referral of all veterinary medicinal products containing active substances...
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MUH
10th October 2012 -
Starting of the telematic submission of periodic safety update reports (PSURs) to AEMPS
From October 1st, 2012 on-line submission of PSURs to AEMPS will come into operation. This application shall remain in service until the European Medicines Agency's (EMA) PSUR repository become operative.
Highlights
Guía del paciente portador de dispositivos de estimulación
cardiaca en seguimiento remoto
La Agencia Española de Medicamentos y Productos Sanitarios ha editado la "Guía del paciente portador de dispositivos de estimulación cardiaca en seguimiento remoto" elaborada por la Sección de Estimulación Cardiaca de la Sociedad Española de Cardiología con el objeto de proporcionar a estos pacientes información sobre los sistemas de seguimiento remoto que se han incorporado recientemente en la atención sanitaria y transmitir su utilidad, seguridad y comodidad, de forma que se facilite la utilización de esta forma de monitorización por los pacientes o sus familiares.
Estrategia frente a medicamentos falsificados
2012-2015
La falsificación de medicamentos constituye un importante problema de salud pública. En el año 2008, se puso en marcha la Estrategia Frente a Medicamentos Falsificados 2008-2011. Una vez finalizada esta iniciativa se ha elaborado esta nueva estrategia que mantiene los principios de la anterior y plantea nuevas actuaciones para reforzar su eficacia.
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April 2013 -
May 2013
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June 2013
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October 2013
© Agencia Española de Medicamentos y Productos Sanitarios