The Spanish Agency for Medicines and Medical Devices is a governmental agency belonging to the Ministry of Health, Social Services and Equality.
The regulatory agency for medicines and medical devices of the Spanish government is responsible for ensuring the quality, safety, efficacy and accurate information of medicines and health products from research to use.
in the project
AEMPS will be active in Gravitate Health sections related to user needs (WP1) contributing our expertise on medication reconciliation and collaborative care plan; the development of end-user tools (WP4), information models including European standard for ePIs (WP5), transition from national formats to a common European format now under definition. The agency will also contribute to sustainability and exploitation analysis of the project’s key output (WP7).
Our contribution to the project
1We have developed a software solution that supports the current national electronic SPC and leaflet and chairs the ePI implementation group.
2We have experience in generating medicinal products information as an outcome of the regulatory process using structured information.
A TASTE OF OUR WORK
The Spanish Agency of Medicines and Medical Devices (AEMPS) is responsible for guaranteeing to society, from the perspective of public service, the quality, safety, effectiveness and correct information of medicines and medical devices, from their research to their use, in the interest of the protection and promotion of human health, animal health and the environment.
Address: 1, Campezo St., building No 8, 28022, Madrid, Spain