Implementing ISO IDMP Standards - Implications to Regulatory Affairs and IT within Pharmaceutical Companies
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The International Standards for Identification of Medicinal Products, comprising of five ISO standards, were approved in 2012. These standards were designed to allow unambiguous identification of medicinal products across companies and regions in order to support and improve pharmacovigilance activities. The ultimate goal is a single authoritative data repository for internal and external use. In the European Union, these standards will become mandatory for medicinal product information according to legislation on the 1st of July, 2016. Read on to find out where the industry currently stands and what role the EMA really plays!
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