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Europe, view from a helicopter…

Tjalling Erkelens, CEO, Bedrocan | February 3, 2019

It was difficult to summarize the developing legal situation in the UK, which means that it will be even harder to do so for all of Europe. Let’s focus on the more general aspects of cannabis regulations in the EU. The European Approach Medical cannabis in Europe is regulated as a true pharmaceutical product, however not as a true (registered) medicine. The latter requires a full clinical research pathway – such as with Sativex and Epidiolex (UK based GW Pharmaceuticals.) The European countries that allow patients to attain herbal cannabis (dried flower or extracts dissolved in food grade oil) use a unique capacity called compounding pharmacy. This allows pharmacists to compound specific medicines from Active Pharmaceutical Ingredients (APIs). All based upon a real prescription of a medical doctor or specialist. Canada and the Netherlands both started medical cannabis programs in the early 2000s. Canada separated cannabis from the true pharmaceutical route by establishing access through the ACMP Regulation. This made it easy for Prime Minister Trudeau to allow medical cannabis products for recreational use as well. However, this will not happen in Europe. Although we do see European countries considering access for recreational cannabis use (Netherlands and Luxembourg especially) it is crystal clear that such will only happen in separated programs. European Regulations The European approach is meant to protect the real patients by providing them with appropriate access to medical cannabis and derived products that are produced according to rules and regulations. This is why the European Medicines Agency (EMA) has …

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