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

9 Dec 2019

GBP 699
EUR 979
USD 1,090

Book now

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


David Richardson

David Richardson runs a specialist consultancy in nutrition and food science, DR Nutrition. He holds a visiting professorship at the University of Reading, School of Chemistry, Food and Pharmacy. He began his teaching and research career at the University of London and at the Massachusetts Institute of Technology. He then worked for Nestlé UK Ltd, ultimately becoming Group Chief Scientist. From 2000 to 2005, Professor Richardson chaired a section of an EU Concerted Action Programme (PASSCLAIM), to develop a process for the scientific substantiation of health claims on foods, and from 2009 to 2011 he was a participant and an author in the ILSI Europe PROCLAIM project, which developed further guidance on the science needed to underpin EU and global regulatory frameworks for nutrition and health claims. In 2005, Professor Richardson was appointed a member of the Royal Swedish Academy of Agriculture and Forestry. He is also a Fellow of the Royal Society of Medicine and a member of the UK Nutrition Society. He sits on several industrial and university scientific advisory boards and is scientific advisor to a number of European and international organisations in the area of foods and food supplements.

Penny Viner

After a career in industry as General Manager of a company making licensed natural medicines, food supplements and cosmetics, Penny Viner spent 7 years as Director of the Health Food Manufacturers’ Association (HFMA), whose members manufacture food and food supplement products, and remains its Vice President, with particular responsibility for herbal issues.

Penny also chairs the UK Herbal Forum, and is Director and Secretary of the British Association of Homoeopathic Manufacturers. Previously she was a Director and Secretary of the UK branch of the European Food Law Association.

She was a member of the British Pharmacopoeia Commission Expert Advisory Group on Herbal and Complementary Medicines and a member of the Ministerial Herbal Medicines and Practitioners Working Group, and is currently a member of MHRA’s Manufacturing Industry Liaison Group.

Until end 2013 she was a Project manager for the International Alliance of Dietary/Food Supplement Associations (IADSA), writing its monthly newsletter and coordinating its Scientific Group.

She now writes an International Regulatory Supplement for the European Federation of Associations of Health Product Manufacturers, is Vice-Chairman of its Botanicals Working Group, and is a botanicals expert for the European Botanical Forum.

Penny is also an independent consultant of food and medicines regulation.

Brian Kelly

Brian Kelly is Regulatory Lawyer at Covington and Burling LLP, one of the leading life science law firms in the world.  His practice focuses on EU food and drug law, public and administrative proceedings, European Union law and product liability and safety.

Mr Kelly’s advice on general regulatory matters includes borderline determinations – in particular borderline between medicines and food, borderline between foods (e.g., food supplements and PARNUTS) – health claims, food labelling and promotion/advertising, novel food determinations, and recalls. 

He represents clients before food and medicine regulatory authorities and national and EU courts. He is ranked in Chambers UK and the Legal 500 for food regulatory advice and is a lecturer at University College London in life science regulation.

Book now

9 Dec 2019
9 Dec 2019 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now
Limited places

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Previous customers include...

  • 4-Front Research Limited
  • A Nelson & Co Limited
  • Body Shop International plc
  • Boehringer Ingelheim Pharma GmbH & Co KG
  • Ceuta Healthcare Ltd
  • Dada Consultancy BV
  • Danish Medicines Agency
  • Devenish Nutrition
  • Dr Willmar Schwabe GmbH & Co
  • EGIS Pharmaceuticals PLC
  • Fimea
  • Ginsana SA
  • Helsinn Healthcare S.A.
  • Helsinn Healthcare SA
  • HFMA
  • Johnson & Johnson Limited
  • McNeil AB
  • Meda Pharmaceuticals Limited
  • Norwegian Medicines Agency
  • Pliva Croatia Ltd
  • Pliva Hrvatska d.o.o.
  • Solgar UK Ltd
  • State Agency of Medicines
  • Symprove Ltd
  • Teva UK Ltd
  • University of Chester
  • Wainwright Associates Ltd
  • Winthrop Pharmaceuticals UK Ltd

Overall it was informative, content was fine

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