Last updated on: 18/10/2018
1. Contact details{View data sources/studies associated with this centre}
Name of organisation 
1) Department/Research groupPharmacoepidemiology and Pharmacovigilance department
2) Organisation/affiliationSpanish Agency of medicines and medical devices
Short Name in the inventoryAEMPS
Website/Homepagehttp://www.aemps.gob.es/ 
Administrative Contact
Title Dr
Last name Montero
First name Dolores
Address line 1Parque Empresarial Las Mercedes
Address line 2C/Campezo 1 edificio 8 
Address line 3 
CityMadrid 
Postcode28022 
CountrySpain
Phone number (incl. country code)+34918225335 
Alternative phone number 
Fax number (incl. country code) 
Email address dmontero@aemps.es
Scientific Contact
Title Dr
Last name Montero
First name Dolores
Address line 1Parque Empresarial Las Mercedes
Address line 2C/Campezo 1 edificio 8 
Address line 3 
CityMadrid 
Postcode28022 
CountrySpain
Phone number (incl. country code)+34918225335 
Alternative phone number 
Fax number (incl. country code) 
Email address dmontero@aemps.es
Alternative Scientific Contact
Title Dr 
Last name Maciá 
First name Miguel Angel 
Address line 1Parque Empresarial Las Mercedes 
Address line 2C/Campezo 1 edificio 8 
Address line 3 
CityMadrid 
Postcode28022 
CountrySpain 
Phone number (incl. country code)+34918225315 
Alternative phone number 
Fax number (incl. country code) 
Email address mmacia@aemps.es 
2. Description
The Spanish agency of medicines and medical devices (AEMPS) is a public body which belongs to the Ministry of Health. Its main task is to regulate all aspects of human and veterinary medicines, from authorisation to pharmacovigilance, so that marketed medicines have guarantees of efficacy, quality and safety. Regarding pharmacovigilance, the Agency has developed and currently maintains BIFAP, a population based database containing general practitioner’s anonymised clinical records to perform pharmacoepidemiological studies. BIFAP database currently contains clinical records of more than 9 million patients. The AEMPS also is the coordinating centre for the Spontaneous Reporting Scheme in Spain and also administer the database supporting this program (FEDRA).
3. Category
Government based
Charity or non-profit organisation
4. Available resources
 In houseVia Contacts/Network
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