Claudia Baumung, CVUA Karlsruhe, Germany Moran Dvora, Gsap, Israel, ECA Cannabis Working Group
Oliver el-Atma, CVUA Karlsruhe, Germany
Michelle Johnson, Leafcann, Australia, ECA Cannabis Working Group
Dr Andrea Kühn-Hebecker, Concept Heidelberg, Germany, ECA Cannabis Working Group
Silja du Mont, GDP/GCP Inspectorate, Germany
Roland Pietz, GMP Inspector, Cologne, Germany
Luis Meirinhos Soares, GMP / GACP Inspector, Infarmed, Portugal, 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 has already been established, cannabis will not be 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). Hence, the agency will manage and monitor the cultivation, harvest, processing, quality assurance, storage, packaging and distribution of cannabis to wholesalers, chemists 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.
- 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, who currently produce according to GPP, will have to implement EU-GMP standards if they want to supply medical cannabis to the EU market. However, since there is currently no harmonized EU standard and pharmacopoeial monograph (Ph. Eur.) for medical cannabis and extracts, national legislations, guidelines and pharmacopoeial monographs will have to be followed and applied in addition to EU-GMP.
This Live Online Conference addresses specific GMP aspects to consider for Growers, Manufacturers, Start-Ups, Suppliers, Importers, 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. The regulatory Postconference is in particular interesting for RA personnel dealing with Marketing Authorizations.
For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html
you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because
of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Note: Provisional timetable, the actual schedule may vary depending on the situation.
Programme – 14 June 2021
13.00 – 13.15 h Welcome
13.15 – 13.45 h
- GMP for Cannabis: setting the scene
13.45 – 14.00 h
Time for Discussion
14.00 – 14.15 h Break
14.15 – 15.15 h
Requirements for EU GMP Certifications / Manufacturing and Importation Authorization (MIA) in Germany
- GMP Requirements: What you need to know (EU GMP Guideline Part I)
- Aspects to consider for applications for Manufacturing and Importation Authorizations in Germany
- Aspects to consider for analytical labs
- (Remote) Inspections in Europe and beyond: Typical and recurrent compliance issues
15.15 – 15.45 h
GDP for Cannabis
- Requirements for transport to pharmacies, veterinary dispensaries, hospitals
- Requirements for distribution of cannabis through international distribution partners, wholesalers and 3PL partners
15.45 – 16.15 h
Time for additional Questions and Discussion
16.15 – 16.30 h Break
16.30 – 17.30 h
Aspects to Consider for CBD (and other Hemp) Products
- Requirements due to the German Narcotics Law
- How to differentiate between CBD/Cannabis Products for medical use and other CBD (Hemp) Products?
- Which legal rules apply?
- Practical examples
17.30 – 18.00 h
Final Discussion Day 1
Programme – 15 June 2021
10.30 – 11.30 h
Australian GMP Requirements for Medicinal Cannabis and the Export of Product to Europe
- Australian Regulations and the Therapeutic Goods Administration
- Disparity between Eudralex 4, PIC/s PE009-14 and country specific requirements for MC
- Bridging the gap for export to Europe
11.30 – 12.15 h
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
12.15 – 12.45 h
Time for additional Questions and Discussion
12.45 – 13.45 h Break
13.45 – 14.45 h
Overview of Pharmacopoeial Monographs (and other Quality Requirements)
- Europe (Ph. Eur.)
- Germany (DAB / DAC)
- Switzerland (Ph. Helv.)
- New Zealand (Product Quality Standards Monograph)
- USA (USP)
14.45 – 15.00 h Time for additional Questions and Discussion
15.00 – 15.15 h Break
15.15 – 16.15 h
Israel Medical Cannabis Regulation & Export to Europe
- 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
16.15 – 17.15 h
Experiences – Lessons learned
- Application of GMP principles to Cannabis:
- Quality management System (QMS)
- Facility Design
- Qualification / Validation: Points to consider
17.15 – 18.00 h
Final Discussion Day 2