AEMPS

Spanish medicines and medical devices agency in Madrid, created in 1997 and reporting to the health ministry, which regulates human and veterinary medicines, medical devices, cosmetics and personal care products. Authorises medicines under national and European procedures, licenses and inspects manufacturers, importers and distributors for good manufacturing and distribution practice, runs the Spanish pharmacovigilance system with its regional centres and the device vigilance system, operates its own official control laboratory, authorises clinical trials and manages medicine shortages and supply problems.