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 699 599 *
EUR 979 839 *
USD 1,090 934 *
* When you book before 24 Oct

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


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.

Book now

9 Dec 2019
9 Dec 2019 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
GBP 599.00
EUR 839.00
USD 934.00
Until 24 Oct*
Enrol now
Limited places

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • Abbott Biologicals BV
  • Avicenna
  • Bayer Consumer Care AG
  • Besins Healthcare Pharma Services Ltd
  • Boehringer Ingelheim Pharma GmbH & Co KG
  • Boots UK Ltd
  • Bristows LLP
  • Britannia Pharmaceuticals Ltd
  • Ceuta Healthcare Ltd
  • Danish Health and Medicines Authority
  • EuroCaps Limited
  • European Medicines Agency
  • Fimea
  • Ginsana SA
  • Helsinn Healthcare SA
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Mentholatum Co Ltd
  • Morinda UK Ltd
  • Norwegian Medicines Agency
  • Nutri Imports & Exports Ltd
  • Nutricia Ltd
  • Regulatory Solutions (Scotland) Ltd
  • SUKL State Institute for Drug Control
  • Symprove Ltd
  • Thornton & Ross Ltd
  • Unilever Plc
  • Voisin Consulting Life Science
  • Wainwright Associates Ltd

Overall it was informative, content was fine

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