Regulatory Focus™ > News Articles > Spain Launches new Registry of API Manufacturers, Distributors, Importers

Spain Launches new Registry of API Manufacturers, Distributors, Importers

Posted 18 July 2014 | By Louise Zornoza

Spain Launches new Registry of API Manufacturers, Distributors, Importers

The Spanish Agency for Medicines and Health Products (AEMPS) has launched a registry of businesses involved in the manufacture, import and distribution of pharmaceutical active ingredients in Spain.

The Unified Public Business Registry of Active Substance Businesses (RUESA) is part of the transposition of Directive 2011/62/EU, which addresses counterfeit drugs in the European Union and includes additional controls for active ingredients. The aim of the RUESA is to strengthen the guarantees of legal distribution channels and actions against counterfeit medicines, and the registry currently includes data from over 150 companies established in Spain. Companies included in this register must update their information once a year in January and immediately notify AEMPS of any changes that may affect the quality or safety of the active substances manufactured, imported or distributed.

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