Exploring Routes to Market for Herbals

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 is the Borderline and on which side does my Product Fit?
  • Complying with Medicines Legislation and the Traditional Herbal Medicinal Products Directive
  • Understanding and working with Legislation on Nutrition and Health Claims for Foods and Botanicals
  • What is the future for Botanical Claims
  • Health Claims in Europe: Implications for Marketing and Researchand Development Strategies
  • EU Borderline Law – Key aspects

Programme

Where is the Borderline?

  • Borderlines: how they can affect the design, manufacture and marketing of products
  • The borderline between traditional herbal medicinal products and botanical food supplements
  • Health claims: The European Commission’s evaluation of a) Regulation (EC) No 1924/2006 on nutrition and health claims made on food with regard to nutrient profiles and health claims made on plants and their preparations and of b) the general regulatory framework for their use in foods.
  • Harmonisation/’national rules’: national positive/negative lists; the mutual recognition procedure
  • BREXIT and borderlines

EU borderline law on medicines and foods

  • Primary legislative framework
  • EU medicines borderline case law
  • EU case law on health claims
    • Business to Business Communications (C-19/15)
    • Use of brand names and trade marks
  • Brexit and the borderline
  • The borderline food for thought*

Botanicals the claim authorisation process and current status

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

Panel discussion

Bespoke training

We can customise this course to meet the requirements of your organisation. Contact us to discuss your training requirements.

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Previous customers include...

  • Abbott Biologicals BV
  • Avicenna
  • B Braun Medical Ltd
  • Ceuta Healthcare Ltd
  • Charles River Laboratories
  • CM&D Pharma Ltd
  • COMVITA UK LTD
  • Dada Consultancy BV
  • Danish Health and Medicines Authority
  • Devenish Nutrition
  • Di Renzo SRL
  • Ferring Pharmaceuticals Ltd
  • HFMA
  • Igen Biolab
  • Ipsen Biopharm Ltd
  • Lifes2good
  • McNeil AB
  • Meda Pharmaceuticals Limited
  • Merck Sharp & Dohme Ltd
  • MHRA
  • Nautilus Pharma
  • Novartis Consumer Health SA
  • Nutricia Limited
  • OM PHARMA SA
  • PhaRA
  • Pronova BioPharma Norge AS
  • Real Regulatory Ltd
  • SCHERING HEALTH CARE LTD
  • Thornton and Ross Ltd
  • University of Chester

Overall it was informative, content was fine

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