Tina Cacanoska, PharmaRolly, North Macedonia
Moran Dvora, Israel, ECA Cannabis Working Group
Dr Rainer Gnibl, GMP Inspector, Government of Upper Bavaria, Germany
Dominik Hedderich, Genillard, Germany
Prof Dr Werner Knöss (invited), Head of the German Cannabis Agency, BfArM, Germany
Luis Meirinhos Soares, CANNAVIGIA, former GMP Inspector at INFARMED, Portugal, ECA Cannabis Working Group
Dr Giorgia Tossi, Linnea, Switzerland, ECA Cannabis Working Group
Dr Ingrid Walther, Pharma Consulting Walther, Germany, Leader of the ECA Cannabis Working Group
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.
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.
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.
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Programme –5 June 2024
- GMP for Cannabis: setting the scene
GMP Certification / Challenges and Experiences from current Inspections
- Authorization, registration & import
- Which requirements apply?
- Current issues
The Intersection between GACP and GMP - View on the Inspection of Cannabis GACP and its Relation to GMP
- When does GACP end and (EU) GMP start?
- What will be checked during GACP and EU GMP inspections?
- Observations in inspections
- Open questions and issues to be solved
Regulatory Status and Quality Standard of Cannabinoids Manufacture
- Pharma, food and cosmetic products and requirements
- How to differentiate between CBD/Cannabis Products for medical use and other CBD (Hemp) Products?
- Which legal rules apply?
- Practical examples
Final Discussion Day 1
Programme – 6 June 2024
Cannabis Cultivation under GACP
- Requirements for buildings, facilities and Equipment
- Cultivation / Harvesting
- Drying /Trimming
- Waste management
Drying of Medicinal Cannabis – Challenges for Process Validation
- Post-harvest processes as a preparation for drying of Medical Cannabis
- Drying process - different types of drying
- Sampling and testing during drying- what are the challenges
- Validation of the drying process and determination of the end of drying
- Curing and why it is needed
- Testing after curing and storage of dry cannabis flowers
Update from the German Cannabis Agency
- Current Status of Medical Cannabis in Germany
- Development of Cannabis Monographs (DAB / Ph. Eur.)
- Changes in the submission requirements for AmRadV applications
- Current Challenges
Israel Medical Cannabis Regulation
- The Israeli Medical Cannabis unit and the licensing process
- Major guidelines: IMC-GAP, IMC-GMP, IMC-GDP, IMC-GSP
- Differences and similarities: Israel vs. Europe
- The export process to Europe
- The import process of medical cannabis to Israel
Experiences – Lessons learned
- Application of GMP principles to Cannabis:
- Quality management System (QMS)
- Facility Design
- Qualification / Validation: Points to consider
Final Discussion Day 2