Zielsetzung
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. But what qualifies as medical grade cannabis? This conference will give you an overview of all relevant regulatory and GMP/GDP requirements and aspects of medical cannabiss.
Hintergrund
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 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.
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 German Narcotics Law.
Zielgruppe
This conference addresses specific GMP aspects to consider for Growers, Manufacturers, Start-Ups, Suppliers, Importers, QPs and QA personnel involved in Cannabis production. The topics provided are also of interest for GMP/GDP Inspectors responsible for issuing a GMP certificate or manufacturers- / import license.
Programm
Welcome and Introduction
- GMP for Cannabis: setting the scene
- GMP and GACP in Greece
- Possible pitfalls and strategies to avoid them
- Timeframe and steps to acquire a license
- Greek National Organization for Medicines (EOF)
- Future issues to be solved
- Aspects to consider for applications for Manufacturing and Importation Authorizations
- Aspects to consider for analytical labs
- GMP certification: What you need to know
- Inspections in Europe and beyond: Typical and recurrent compliance issues
- Short overview of the German Narcotics Law („Betäubungsmittelgesetz“, BtMG)
- Necessary documents for granting general licenses and import / export authorizations by the Federal Opium Agency (BfArM)
- Surveillance with respect to inspections
- Reasons for refusal
- Requirements for transport to pharmacies, veterinary dispensaries, hospitals
- Requirements for distribution of cannabis through international distribution partners, wholesalers and 3PL partners
- What to test
- How to test
- Limits
- Challenges and problems
- Facility plan, design, set up – Hurdles and Solutions
- From Seed to…
- …Harvest and drying
- Requirements to fulfil
- Agreements & Responsibilities
- EU GMP Conformity & Import License
- Stability studies, shelf life
- Application of GMP principles to Cannabis
- Quality management System (QMS) including Qualification/Validation
- DAB Monograph “Cannabis Flos”: Points to consider
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