GMP for Cannabis – what you need to know - Live Online Conference
5/6 June 2024
Course No. 21205
Speakers
Dr Ingrid Walther
Pharma Consulting Walther
Dr Rainer Gnibl
GMP Inspector
Note: All times mentioned are CEST.
Objectives
Medical cannabis has been permitted for prescription in Germany since 2017, causing a need for producers supplying pharmacists and physicians with the newly legalized drug. In addition, more and more countries around the world are following Germany by introducing programs in order to legalize cannabis for medical use. But what qualifies as medical grade cannabis? And which aspects have to be considered for CBD-Products? This conference will give you an overview of all relevant regulatory and GACP/GMP/GDP requirements and aspects for medical cannabis and CBD-Products.
Background
In March 2017, the national German legislature expanded the options for prescribing medical cannabis products by passing a law amending provisions under the Narcotics Law and other regulations. These products, however, must comply with the relevant requirements laid down under Medicinal and Narcotics Law, including GACP/ GMP and GDP. Therefore, the BfArM (the Federal Institute for Drugs and Medical Devices) has taken over new responsibilities by establishing the Cannabis Agency. This agency is meant to help in ensuring supplies for medical-quality cannabis. Unlike AGES in Austria, though, where cultivation of medical cannabis was already established, cannabis is not cultivated by BfArM itself, but by commissioned companies. Cannabis is not meant to be stored directly at BfArM during any stage of the purchasing, harvesting or distribution process. These steps will be carried out by relevant producers or other commissioned companies (i.e. suppliers, importers, wholesalers). Hence, the agency manages and monitors the cultivation, harvest, processing, quality assurance, storage, packaging and distribution of cannabis to wholesalers, pharmacists or manufacturers. The 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. In summary:
The Cannabis Agency is responsible for ensuring that only medical grade cannabis is supplied,
The relevant requirements based on the underlying legal framework (including Pharmacopoeias) and the corresponding GMP, GDP and GACP guidelines must be complied with, and finally
Cannabis for medical purposes is also subject to the provisions of the Narcotics Law.
Non-EU suppliers will have to implement EU-GMP standards if they want to supply medical cannabis to the EU market. Meanwhile, European pharmacopoeial monographs (Ph. Eur.) describing the quality requirements for cannabis flower (as API and for direct prescription to patients) and for CBD have been established and will be implemented as of 1 July 2024. However, questions still arise, because:
There is no harmonized “EU GMP Cannabis Standard” available for medical cannabis (API / Drug 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 (and Dronabinol) only national monographs exist so far.
Thus, national legislations, guidelines and pharmacopoeial monographs will have to be followed and applied in addition to EUGMP.
Target Group
This Live Online Conference addresses specific GMP 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.
Technical Requirements
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Seminar Programme as PDF