This seminar aims to assist delegates to an understanding of how the borderline between medicines and foods may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them
Medicines treat, cure or prevent illness. Foods provide nutrition. But are the distinctions so clear?
Foods also have a physiological effect and a role in disease risk reduction – and substances whose purpose is nutritional may be presented as medicines. An understanding of where the borderline lies between medicines and foods is essential for the successful marketing of specialist health products: getting it wrong is a costly route to market failure. However,the regulatory framework is detailed and complex, requiring a knowledge of the relevant legislation.
This seminar will highlight the most important regulatory issues, with particular focus on the borderline between botanical food supplements and herbal medicinal products, and on health claims and the long outstanding question of what the authorisation process for botanical claims will be.
Topics to be covered at this seminar:
Where is the borderline?
The borderline: food for thought
Health claims in Europe: implications for marketing and research and development strategies
EU borderline law on medicines and foods
Case study: discussion on borderline products
We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.