Legislation of Phytotherapeutic Agents

Online

Course Overview

This course examines the legal, regulatory, and ethical frameworks governing phytotherapeutic and herbal medicinal products, with a focus on the European and Greek context and selected comparisons with the United States. Students explore product classification, authorization procedures, pharmacovigilance, labeling, packaging, and documentation requirements, while also considering sustainability and quality standards in the use of natural resources. The course also addresses the regulation of cosmetics containing natural ingredients and the legislative framework surrounding medicinal cannabis.

Key Topics

  • Regulatory frameworks for herbal and phytotherapeutic medicinal products
  • Marketing authorization, variation, and renewal procedures
  • Pharmacovigilance and regulatory documentation
  • Legal and regulatory requirements for natural medicinal products
  • Cosmetics legislation and the use of natural ingredients
  • Regulatory aspects of medicinal cannabis
  • Labeling, packaging, and submission processes
  • Good Manufacturing Practice (GMP) and Good Agricultural and Collection Practice (GACP)

Learning Outcomes

By the end of this course, students will be able to:

  • Understand the main legal and regulatory frameworks for phytotherapeutic and herbal medicinal products
  • Identify key procedures and documentation required for product authorization and compliance
  • Navigate core regulatory sources and information platforms
  • Assess the regulation of cosmetics and natural ingredients in product formulations
  • Evaluate the benefits, risks, and legal considerations associated with herbal products and medicinal cannabis
  • Apply good practice principles related to quality, safety, and regulatory compliance

Teaching & Learning Format: Online

Assessment

  • Weekly multiple-choice assessments
  • Group presentation
  • Final written report
  • Class participation and discussion

Indicative Background: Introductory familiarity with medicinal product legislation is recommended. A background in plant science may also be helpful.

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