Borderlines between Medicines and Food

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

Course Overview

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.

Why you should attend

Topics to be covered at this seminar:

  • Where the borderline lies and on which side your product fits
  • Comply with medicines legislation and the European Directive on Traditional Herbal Medicinal Products
  • Understand and learn how to work with the Nutrition and Health Claims Regulation
  • Discuss the future for botanical claims with industry experts
  • Learn about the health claims in Europe and the implications for marketing and research and development strategies
  • Master the key aspects of EU borderline law


Where is the borderline?

  • Borderlines: what are they and why is it important to recognise them?
  • Borderlines: how they can affect the design, manufacture, labelling and marketing of medicinal and food products
  • The borderline between traditional herbal medicinal products and botanical food supplements
  • The outcome of the European Commission’s REFIT report on EC Regulation 1224/2006 on a) Nutrition and health claims made on foods with regard to nutrient profiles and health claims made on plants and their use in foods
  • Harmonisation or ‘national rules’? Mutual recognition?
  • BREXIT and borderlines

The borderline: food for thought

Health claims in Europe: implications for marketing and research and development strategies

  • The European laws on nutrition and health claims – scope, provisions, global impact
  • The scientific substantiation of health claims including PASSCLAIM
  • Role of the European Food Safety Authority (EFSA)
  • Impact on existing and new product claims, formulations and recipes, commercial communications and product development and innovation

EU borderline law on medicines and foods

  • Primary legislative framework
  • EU medicines borderline case law
  • EU case law on health claims
  • Brexit and the borderline

Case study: discussion on borderline products

Book now

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.

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Previous customers include...

  • A Nelson & Co Ltd
  • Bayer Consumer Care AG
  • Dada Consultancy BV
  • Di Renzo SRL
  • EGIS Pharmaceuticals PLC
  • Emtex BVBA
  • European Medicines Agency
  • Forest Laboratories UK Ltd
  • Ginsana SA
  • Holland & Barrett Retail Limited
  • Igen Biolab
  • Lifes2good
  • Merck KGaA
  • Morinda UK Ltd
  • Nestec Ltd
  • Nutricia Ltd
  • Oriol Cerda Alimbau
  • Pfizer Limited
  • Pronova BioPharma Norge AS
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Solgar UK Ltd
  • SUKL State Institute for Drug Control
  • Takeda Pharma A/S
  • Topotarget AS
  • Unilever Plc
  • Voisin Consulting Life Science

Overall it was informative, content was fine

Sorwar Choudhury, Head of Medical, Pharmacovigilance and Regulatory Affairs, Meda Pharmaceuticals Limited