Quality Requirements for Medicinal Cannabis and Respective Products in the European Union – Status Quo

Abstract

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 were 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. To facilitate free distribution of such products between EU member states in future and to harmonise requirements for quality and GMP, an EU-wide approach is needed. As a first step this should be realised by implementing monographs for cannabis medicinal products in the European Pharmacopoeia.

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