ECA conference on GMP for Cannabis

We attended the ECA conference on GMP for Cannabis in Heidelberg late October 2019 – time flies when you are busy…

International meeting

It was a great conference to gain and update knowledge and meet the other participants. People from all over the world had found their way to Heidelberg – e.g. from North Macedonia, Austria, Canada, USA, Colombia, Australia, Portugal, Greece, UK, Holland. And it was exciting to have their view on growing cannabis and the challenges in the business area. We met a very enthusiastic man from US who really couldn’t understand we talked so much about quality and then never had tasted cannabis and not knowing if we were selling / counselling on good stuff or not…

The focus was on Germany – and EU in general – but by teaming up with the other Danish participants we made sure that it became shared knowledge that not only Germany but also Denmark has strict national demands on medicinal cannabis.

Greece

We learned that Greece has posed cannabis laws that allows everybody to apply for licences to grow and produce cannabis – but does not have the legal foundation translated to English and have a lot of references into more common Greek laws. You cannot outsource any activities not even analysing and must be able to perform a NIR-spectroscopy to identify the active substances in cannabis.

The German regulation

The German regulation demands that cannabis products sold in usual pharmaceutical formulations e.g. capsules are approved as a medicinal product with a marketing authorisation. This was a big surprise for most of the participants. If a company doesn’t get it’s product / production approved by the yearly tender – and doesn’t have a marketing authorisation, you can only sell “small” amounts through the pharmacies which have to make a final production step. Interestingly, it was also revealed that it is possible to sell medicinal cannabis products, which have been radiated to obtain the necessary microbiological grade, by applying for permission to perform this production step.

Other learnings

It is only possible to export the final products – and only as oily extractions – from Colombia.

All in all, the conference gave an update of all relevant German regulatory and GMP/GDP/GACP requirements for production and growing of cannabis. Among other subjects on the conference were the steps of growing Cannabis for medicinal use, Supplier Qualification and handling (facilities, packaging, release), Inspections, and Quality testing of Cannabis Flos and Extract.

No harmonized legislation is a challenge

Currently no harmonized legislation is available neither globally nor in the EU, however in general – GACP, EU-GMP/GDP, Narcotics Law, Pharmacopeias and the national medicinal requirements applies for medicinal cannabis products in Europe. It also generally applies, that non-EU suppliers must implement EU-GMP standard for their productions.

The conference made it clear, that growing and production of cannabis in a pharmaceutical setting often requires specialist expertise and can be complicated for many start-up cannabis companies.

Facts

In Denmark, according to the Act on the medicinal cannabis pilot programme and the development scheme, permission can be obtained for cultivation, manufacture of primary products, manufacture and import of primary products, et al.

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