Alphatopics, Kaufering, Germany.
Planta Med. 2023 Jul;89(8):808-823. doi: 10.1055/a-1808-9708. Epub 2022 Mar 25.
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.
药用大麻及其制品作为单一患者处方，在没有常规上市许可的情况下，在欧盟成员国已经供应了几年。荷兰是第一个实现这一目标的成员国；与此同时，其他成员国也纷纷效仿。如今，除荷兰外，德国是此类产品最重要的市场。然而，欧盟成员国批准药用大麻及其分发给患者的监管框架根本没有协调一致，存在明显的国家法规。关于这些产品的质量，一般适用于草药药物的要求，如欧洲药典、国家药典以及 EMA 指导文件中规定的要求，除了欧盟的 GMP 要求外。然而，对于一些方面，每个欧盟成员国都按照自己的方式解释这些要求。为了促进未来此类产品在欧盟成员国之间的自由分配，并协调质量和 GMP 要求，需要采取全欧盟的方法。作为第一步，这应该通过在欧洲药典中实施大麻药用产品专论来实现。
