Borderline Products: Medicine or Food – Training

In the EU a medicinal product placed on the market are required to have a marketing authorization. However, because of their composition (pharmacologically active ingredients) or marketing claims it can be difficult to define a medicine from a food. Such products are defined as borderline.

Once a food is classified as a medicine by the competent EU Member State authority it is deemed illegal resulting in its removal from the market. A number of such classifications have been judged to have been illegal and classification of foods as medicines incorrectly applied.

This presentation will review the factors based on both legislation and case law over what determines a medicine from a food. How to mitigate the risk of formulating a product as a medicine and what options are open to have a product assessed prior to it been placed on the market.

Training Content:

  • Overview of 2001/83/EC (as amended) and its implications to food law
  • How have alterations in the definition of a medicine impacted classification
  • Food vs. Food Supplements and medicines classifications
  • Defending and overturning medicines classifications
  • Member State powers in defining medicinal status
  • Enforcement in the UK

Course Outcome:

  • Understand the legislation surrounding the classification of borderline products
  • Develop knowledge of what factors may result in medicine classification
  • Increased awareness of the place of Mutual recognition to help retain products on-shelf
  • What to consider if your food product is defined as a medicine
  • Where to seek assistance if you want to fight classification

Training Dates