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A Practical Guide to Licensing Herbal Medicinal Products
First Edition
by Thomas Brendler

A Practical Guide to Licensing Herbal Medicinal Products answers all questions most frequently asked by manufacturers and provides full guidance on license applications.

The Traditional Herbal Medicinal Product Directive (THMPD) was implemented in the UK in 2005 and allows herbal products to be registered under medicines law. By 2011, every pharmaceutical company manufacturing herbal medicines that are sold in the UK and European Union must have obtained a market authorization.

As a manufacturer of such products, you need to ask the following:

  • What type of herbal products are you manufacturing?
  • Would your product comply with the regulations?
  • Are you required to register your herbal products?
  • What type of registration or license do you need?
  • What evidence and manufacturing data do you need to provide?
  • What are the packaging and leaflet requirements for your product?
And, most importantly:
  • How do you apply for a license?
A Practical Guide to Licensing Herbal Medicinal Products answers all these questions and also provides full guidance on product registration, including step-by-step guidance on completing the application forms, information on to whom the forms should be submitted and what costs are involved.

All the official legal guidelines and forms are included within the guide.

A Practical Guide to Licensing Herbal Medicinal Products is easy and practical to use, guiding you and your company through the initial decision-making process to registering your herbal products.

Contents

Product Eligibility

1. Classification of herbal (medicinal products)

  • Classification as a medicine
  • Herbal Medicinal products
  • Traditional herbal medicinal product
  • Products with a well-established medicinal use
  • Alternative marketing opportunities
  • Borderline products
2. Content and Presentation

2. Proof of Tradition

  • The EU-regions
  • Sources for information on traditional use
3. Common Technical Document

  • Pyramid chart
  • Module 1: European Union administrative information and prescribing information
  • Module 2: Common technical document summaries
  • Module 3: Quality—chemical, pharmaceutical and biological information for chemical active substances and biological medicinal products
  • Module 4: Non-clinical study reports
  • Module 5: Clinical study reports
4. Good Agricultural and Collection Practice

  • General definition of good agricultural and collection practices
  • Benefits of GACP
  • Contaminants and adulteration
  • The safety of herbs
  • Conservation and sustainability
  • Environmental impacts
  • CITES
  • Conservation in the UK
  • Ethical standards and social responsibility issues
  • Intellectual property rights
5. Quality Requirements for Traditional Herbal Medicinal Products

  • Special issues and challenges when evaluating herbal products
  • Definition and legal basis
  • General aspects of quality assurance and quality control of herbal (medicinal) products
  • Labellling
  • Quality requirements and methods
  • General checklist: quality requirements for a license application
  • Detailed checklist: definition of raw material/quality
  • Detailed checklist: definition of extract quality
  • Detailed checklist: definition of quality of the finished product
  • Detailed checklist: finished product pre-check for further supply and testing
  • General addendum
6. Safety and Pharmacovigilance

  • Non-clinical overview
  • Pharmacokinetics
  • Toxicology
  • CTD non-clinical overview
  • Clinical overview
  • Periodic Safety Update Reports
7. Labelling

  • The directives
  • Summary of product characteristics
  • Requirements for packaging components
  • Requirements for packaging leaflets
  • User testing of package leaflets
Part 3 The Practicalities

8. Submission of THM Registration Applications-frequently Asked Questions

  • Is there any guidance available?
  • What are the prerequisite for submitting an application?
  • What are the registration application fees and when and how do I pay?
  • How do I fill in the application form?
  • Do I submit on paper of electronically?
  • What are the formal requirements for my dossier?
  • Where do I submit?
  • Whom do I ask for further guidance?
  • What happens next?
Part 4 Appendices

  1. MHRA documents
  2. EU-EMEA documents
  3. PhEur documents
  4. List of official monographs
  5. Miscellaneous
Index

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A Practical Guide to Licensing Herbal Medicinal Products
First Edition
by Thomas Brendler

2009 • 700 pages • $435.00 + shipping
Texas residents please add 6.75 % sales tax

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