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 authorizations for a couple of years. The Netherlands was the first member state to realize this; in the meantime other member states have followed. Today, aside from 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 harmonized 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 harmonize requirements for quality and GMP, an EU-wide approach is needed. As a first step, this should be realized by implementing monographs for cannabis medicinal products in the European Pharmacopoeia.

Key words

Cannabis sativa - Cannabaceae - herbal preparation - herbal medicinal product - European Pharmacopoeia - European Medicines Agency - Committee on Herbal Medicinal Products

^# Dedicated to Professor Dr. Gerhard Franz on the occasion of his 85th birthday.

Publication History

Received: 28 January 2022

Accepted after revision: 22 March 2022

Accepted Manuscript online:
25 March 2022

Article published online:
23 June 2022

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