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Getting ready for the Identification of Medicinal Products

Beyond standard procedure: how to take advantage of new rules on medical product data
Beginning in mid-2016, life sciences organizations operating in Europe as well as selling medicinal products in Europe will be required to adhere to a new set of regulations that govern the way their products must comply with industry standards. The Identification of Medicinal Products (IDMP) regulations will require all pharmaceutical products to be identified according to a set of data standards defined by the International Organization for Standardization (ISO). The ISO data model was defined in 2012, but final guidance related to the implementation of these requirements remains unpublished. Europe will be the first region to implement IDMP standards; the European Medicines Agency (EMA) will publish the full implementation guidelines for IDMP in 2015, leaving those who wait little time to respond. Life sciences organizations will be expected to demonstrate compliance by 1 July 2016, creating an urgency to initiate planning activities now. We anticipate that other regions will be quick to follow Europe’s example, but history warns us not to expect that IDMP implementation requirements will be consistent everywhere. This means that it will be critical for life sciences organizations to develop and implement a robust, flexible and sustainable approach to medicinal product master data standardization. That said, embracing standardization of product information as mandated by the new regulations is viewed by some, including EY, as an opportunity to drive process and other efficiencies, thereby creating competitive advantage across the value chain. There is no doubt that leveraging product master data across R&D, manufacturing, supply chain and commercial divisions will increase operational effectiveness in those organizations that take a strategic view of IDMP requirements. In this article, we explain how organizations can prepare for the implementation of the IDMP requirements — and, importantly, how they can turn it to their advantage by leveraging their product master data assets and capabilities and ensure that they can effectively manage the uncertainty caused by lack of clear regulatory direction.

18th March 2016

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EY Life Sciences

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