Regulatory requirements for import and distribute medicinal cannabis in Europe and Germany in particular (10638)

The regulatory framework for the import of medicinal cannabis and its distribution to patients in the EU member states not harmonised at all and there are distinct national regulations. The first part of the webinar has a focus on general requirements in place applicable in all EU member states and the specific requirements in Germany.  Regarding the quality of such products, the general requirements for herbal medicinal products as defined in the European Pharmacopoeia, national pharmacopoeias and the EMA guidance documents in place beside GMP requirements in the EU are applicable. The second webinar has a focus on quality requirements applicable in Europe and Germany.

Topics covered:

Webinar 1:

• Definitions and product categories for herbal medical products in Europe
• Regulatory status of Cannabis medicines in Germany
• Particular aspects for magistral preparations in Germany
• GACP requirements
• EU-GMP requirements
• GDP requirements
• Requirements related to narcotic law
• Considerations and requirements for import

Webinar 2:

• Quality requirements for Cannabis flowers
• Quality requirements for Cannabis extracts
• Formal requirements regarding CoAs
• Stability data needed
• Aspects regarding microbial quality and decontamination procedures

Duration in total approx. 4 hours
Lecture language: English | Slides: English

Your speaker: Prof. Dr. Markus Veit is the managing director of ALPHATOPICS GmbH. He studied pharmacy in Frankfurt, obtained his doctorate at the Julius-Maximilians-University in Würzburg and was assistant professor there in the Department of Pharmaceutical Biology. He is a member of the German pharmacopeial expert committee at BfArM. In the past 25 years, he has worked as a managing director in companies providing services for the pharmaceutical industry with a focus on pharmaceutical development, testing and regulatory affairs. At the same time, he designed and led numerous training and continuing education events for employees in the pharmaceutical and medical device industry. He is an expert for herbal medicinal products and was involved in numerous applications for marketing authorisations of herbal medicines in Europe and rest of the world. In the past years he is increasingly involved in projects related to medicinal and other cannabis products.

Webinars allow you to participate in training courses and lectures conveniently from anywhere at any time. They are the perfect way to keep up to date with the latest knowledge without much effort. You are also welcome to ask the speaker questions after the webinar.

Note on quota call-off: When booking the entire webinar series, two parts per trained person will be deducted.

We offer attractive special prices with special benefits for large groups - please contact us.