As from 1 October the application of the electronic headquarters of the AEMPS, Telematic Fee Payment, will have a new bank payments gateway available so as to increase payment security and facilitate procedures...
The AEMPS starts a pilot study to include the opinion of the Ethics Committee (EC) in the assessment conclusions of Clinical Trial Applications undergoing the Voluntary Harmonisation Procedure. The VHP guidance document has been updated.
The identification of an investigational medicinal product requires at least a name for the medicinal product and at least a name for the active substance...
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.
The Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency of Medicines and Medical Devices) publishes the second version of the document “How are Medicines and Medical Devices regulated in Spain”. As a public service, the mission of the AEMPS is to give guarantees to the general public on the quality, safety, efficacy and accurate information on medicines and medical devices, in the widest remit, from research to end use, to protect and promote health in both human beings and animals. Its vision is to strengthen the reference health authority for citizens and healthcare professionals with regard to guarantees of quality, safety, efficacy, information and accessibility of medicines and medical devices.
The Charter of services of the “Agencia Española de Medicamentos y Productos Sanitarios” (the Spanish Agency of Medicines and Medical Devices) for citizens and users, provides information about the entrusted services, about the rights they have in relation to these services, and about the quality commitments regarding the improvement of public services they render, responding to citizens' and users' demands. This Charter of services is based on the Royal Decree 951/2005 of 29th July, establishing the general framework for quality improvement in the General State Administration.
The Spanish Agency of Medicines and Medical Devices (AEMPS) has launched the Spanish Clinical Studies Registry (REec). The Registry, available on the following website: https://reec.aemps.es, provides information to patients and healthcare professionals about clinical researches approved in Spain, in order to report on ongoing researches on a given disease, syndrome or a related treatment with human medicines.