The Company Core Data Sheet in Light of XML-Authoring and IDMP Master Data Implementation

Abstract

Labeling decisions for core labeling and/or local labeling capture the outcome of all discussions on the product statements that are necessary to ensure safe and effective handling of pharmaceutical products, with a special focus on the decision concerning known, suspected, or hypothetical risks. Such decisions may determine if a topic is to be included in the label or provide a rationale for exclusion from the label. The need to provide special advice to users and the type of advice (eg, contraindications, precautions) are subject to labeling decisions as well. While the problem is well known to pharmaceutical companies, and technical solutions such as XML-based authoring/coding systems try to offer support from the information technology sector to handle the business problem, the current identification of medicinal products (IDMP) requirements raised by health authorities worldwide have put a new focus on the problem. This article will elaborate on the basic business problem and its requirements with respect to a solution.