D2-UC1: Regulatory Terms by Jurisdiction

Introduction

The regulatory term used by jurisdiction are not harmonized in any manner this lead to a number of example where there is difference in the terminology used for the same entity or there are more or less specific terminology used examples would be that a Tablet could be used in one jurisdiction where as the more specific Film-coated Tablet is used in another. Another example would be that if a material is removed during the processing of the medicinal product then it does not need to be reported. However, in another jurisdiction they mandate that all materials are reported even if they are removed. Further examples are there maybe a specific reporting requirement for an ingredient or difference in the basis of strength.

Related Competency Questions

Modeling Pattern

Pattern: Regulatory Terms by Jurisdiction