There are certain areas of conflict that have emerged after the establishment of the regulatory framework for the production, testing and dispensing of medicinal cannabis in individual European member states. At the same time cannabis for products in other markets, such as food supplements and products for vaping, are increasingly restricted by regulations. For any of these product categories requirements in place in Europe are inconsistently interpreted by the authorities of the various EU member states. In a webinar we will address some of the topics in this context as well as outline the current (different) interpretations of authorities in the EU and what should be considered for the future rollout of cannabis products in European markets.
- There are indistinct specifications in the DAB monograph for cannabis extracts and increasingly extracts under development or already on the market which do not fall under the definition of the DAB monograph. This results in a couple of issues to be resolved:
- Which requirements need to be met for extracts not covered by the DAB monograph?
- How to specify degradation products for extracts not covered by the DAB monograph?
- How to deal with requests from authorities in EU member states to specify further degradation products, beside CBN?
- There are different interpretations regarding the demarcation of GACP and GMP, especially considering the drying of cannabis flowers and the preparation of extracts. This results in a couple of questions to be answered and issues to be resolved:
- Why is the demarcation between GACP and GMP different for flowers and extracts, respectively?
- In which cases is the drying of cannabis flowers considered to be a critical process parameter, which needs to be performed under GMP?
- Why are the microbiological quality and the risk of contamination with mycotoxins very important critical quality attributes of cannabis flowers (for any purpose)?
- What is the impact of GMP demarcation on the risk of bioburden and contamination of cannabis flowers?
- What is the consequence of a wrong demarcation concept and a possible violation of EU GMP requirements?
- Can any of the problems related to bioburden be overcome by irradiation?
- What are the risks of irradiation?
- There are general requirements for vaporisers and other drug delivery products for the administration of medicinal cannabis:
- What are the general requirements for drug delivery devices in the EU (dosing devices, syringes, vaporisers, inhalers, …)?
- Why is it mandatory in the EU to use only vaporisers qualified as medical devices holding a (current) CE mark?
- What are the requirements for obtaining a CE mark for vaporisers? (This topic will further elaborated in a separate webinar.)
- There are different consequences of the EFSA paper on the safety of CBD in novel foods which are not only related to placing food supplements, but also products for vaping and cosmetics containing CBD on EU markets.
- How could the existing safety concerns be ruled out?
- What needs to be considered for safety studies to be conducted?
- Why are the safety concerns raised by EFSA also relevant for cosmetics and products intended for vaping?
- Is a "prescription" of such products by MDs and/or dispensing in pharmacies (still) legal?
Duration: 120 minutes
Language: English | Handout: English
...more from your speaker Dr. Markus Veit...
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