Import, analysis, and release of pharmaceutical cannabis
As a Qualified Person and Regulatory Affairs Manager, Dr Nicole Kordek is responsible for the release of batches of medicinal cannabis at the WESSLING Group. In an article for the trade journal pharmind, the licensed pharmacist provides detailed information on medicinal cannabis - from import, analysis, and release (GMP/GLP/GCP), and extract production, quality requirements, suppliers, testing laboratory, logistics and transport companies.
Currently, the supply of medical cannabis to patients in Germany is covered exclusively by imports, particularly from Canada, the Netherlands, Denmark, Portugal, and Australia. Nicole Kordek therefore sheds light, in her article, on the different legal regulations for medicinal cannabis products that must be observed by producers/suppliers and importers/exporters. In doing so, she distinguishes the legal framework conditions regarding quality, the need for EU retests and batch release between imports from EU member states as well as from non-EU countries.
Her workplace, the WESSLING GMP laboratory site Münster, has a narcotics licence and conducts tests of cannabis flowers and extracts according to the current pharmacopoeias. The experts at WESSLING also support importers in the following way:
- setting up GMP-compliant QM systems
- applying for a wholesale authorisation according to Section 52 of the German Medicines Act
- applying for a manufacturing authorisation according to Section 72a of the German Medicines Act
- setting up the position of the Qualified Person and the Responsible Person
You can find a complete overview of our cannabis services here. We would also be happy to provide you with our consulting and analysis services. Please do not hesitate to contact us.
You can download the article here
Your contact to our experts
- Dr. Maik Siebelmann
- +49 251 13 39 880
- pharma@wessling.de
