Navitas Life Sciences

WhitePaper - A unique view of sustainable IDMP solutions

What is IDMP? As most, if not all, pharmaceutical companies are aware, from July 2016 internally agreed terminology for the classification, retrieval, presentation, risk benefit evaluation, and assessment of pharmacovigilance and medicinal product information will become legally enforceable. These requirements apply to member states, marketing authorisation holders (MAHs), and the Agency (EMA). The vehicle of choice is a set of five ISO standards, generally referred to as the Identification of Medicinal Products, or IDMP .

The five IDMP standards define and describe a set of data elements and a structured data model to facilitate data capture, data maintenance, and data exchange. It consists of about 243 individual data points that, collectively, enable unique identification and characterisation of any medicinal product and its associated components, in any phase of its product life cycle (i.e. first in man, up to withdrawal from market), and registered anywhere in the world.

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