Medical Cannabis – Cultivation, Processing, Systems & Technology

Background

Medical cannabis products must comply with the relevant requirements laid down under Medicinal and Narcotics Law. The relevant requirements based on the underlying legal framework (including Pharmacopoeias) and the corresponding EU GMP/GDP and GACP guidelines must be complied with when supplying medical cannabis to the EU market.

The EU GMP inspectorates are responsible for issuing manufacturing and import licenses or “GMP Certificates”. Thus, they will perform inspections at the sites of manufacturers who apply for these certificates and licenses.

Meanwhile, European pharmacopoeial (Ph. Eur.) monographs describing the quality requirements for cannabis flower (API or for direct prescription to patients) and for CBD have been established and implemented. However, questions still arise, because:

• There is currently no harmonized “EU GMP Cannabis Standard” or “Global GMP Cannabis Standard” available for medical cannabis (API / Herbal Medicinal Product).
• The Ph. Eur. Cannabis Flower and CBD monographs are currently not harmonized with the corresponding USP (draft) monographs.
• Regarding quality requirements for Cannabis Extracts (Herbal Drug Preparation) only national monographs exist so far.

Thus, national regulations, guidelines and pharmacopoeial monographs will have to be followed and applied in addition to EU-GMP.

Target Audience

This conference addresses specific GMP and technical aspects to consider for Growers, Manufacturers, Start-Ups, Suppliers, Importers, Wholesalers, QPs and QA/QC personnel involved in Cannabis production and release. The topics provided are also of interest for GACP/GMP/GDP Inspectors responsible for issuing a “GMP- certificate” or manufacturers- / import license.