By Scott Mitrueter, Jan. 4, 2017
Beginning in early 2017, life sciences organizations that intend to manufacture and/or market medicinal products within the European Union will be required to comply with the Identification of Medicinal Products (IDMP) regulations, a global framework for identifying medicinal products, set forth by the European Medicines Agency (EMA).
Intended to create the utmost transparency between regulators, manufacturers, suppliers and distributors, IDMP will ultimately ensure public safety by enabling greater operational efficiencies and reducing errors and inconsistencies, as well as reducing the risk of negative audit results. Unique IDs are introduced at every stage of the supply chain for full traceability.
Although the requirements are not fully established, many companies currently do not see IDMP implementation as a major business challenge that they need to start dealing with. This, however, could turn out to be a very big mistake.
The vast amount of data disclosure required for IDMP compliance poses a significant challenge to organizations, as all too often product information is scattered across a variety of systems and business functions. No single entity maintains ownership of the necessary data.
How do you ensure full control of your product releases, labels and IDMP data sets on a global scale? To gain a better understanding ahead of the regulation being fully established, here are three of the most important questions that should be considered, along with insights to guide the process.
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