Medicinal cannabis and respective products have been available in EU member states as single-patient prescriptions without regular marketing authorisations for a couple of years. The Netherlands was the first member state to realise this, in the meantime other member states have followed. Today, beside the Netherlands, Germany is the most important market for such products. The regulatory framework for the approval of medicinal cannabis and its distribution to patients in the EU member states is, however, not harmonised at all and there are distinct national regulations. Regarding the quality of such products, the general requirements for herbal medicinal products as defined in the European Pharmacopoeia, national pharmacopoeias and the EMA guidance documents in place beside GMP requirements in the EU are applicable. However, for a couple of aspects every EU member state follows its own interpretation of these requirements.
Non-medicinal borderline products with low THC or based on CBD are marketed with health or well-being promoting claims in a regulatory grey zone. For these products as well there are quality requirements, or those requirements should at least be requested.
The webinars aims to provide an overview regarding the current requirements regarding CMC and GMP in EU member states and Switzerland for medicinal cannabis and borderline products. Aspects regarding regulations for narcotics will not be covered by the webinars.
If you would like to book only one lecture, please follow the links below:
Webinar 1 – QA, GACP and GMP requirements
Webinar 2 – CMC requirements for flowers, extracts and products, respectively