Symposium on MEDICINAL CANNABIS | Online intensive training | more part-series (10524)

Medicinal cannabis and cannabis-based 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 allow this, and since then, other member states have followed. Besides the Netherlands, Germany is currently the most important market for such products. However, the regulatory framework for the approval of medicinal cannabis and its distribution to patients in the distinct EU member states is not at all harmonised, 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 alongside GMP requirements in the EU are applicable. However, for a couple of aspects, every EU member state follows its own interpretation of these requirements. With the symposium, we aim to provide an overview of the current requirements in the EU and distinct member states and to enable communication between stakeholders regarding current developments and how to achieve greater harmonisation. 

Brief description of the lectures:

Dr. Malgorzata Meunier, Panaxia Pharmaceutical Industries Ltd.

"Examples of different medicinal cannabis products and respective regulatory frameworks in EU member states" 

After a long period of prohibition, European health institutions have understood the need to regulate patient access to medical cannabis. However, due to regulatory differences in the perception of "what is medical cannabis", Europe still does not facilitate the pathway to obtain finished pharmaceutical products registered under MA.

The aim of this presentation is to provide an overview of the regulations in the main European countries where medical cannabis products are commercially available. Magistral preparations as a means to provide patients with access to medical cannabis (in Germany and Poland) will also be discussed.

Dr. Martin Ziak, Swissmedic

Regulations on medicinal cannabis in Switzerland

The Swiss Parliament approved a revision of the Narcotics Act on 19th March 2021. The revised Narcotics Act and the revised ordinances are expected to enter into force in autumn 2022. The consequences for the marketing authorisation of medicinal products containing the active substance "cannabis" will be discussed.

Kristine Hvolby, Danish Medicines Agency

The Danish pilot programme for medicinal cannabis: quality requirements – so far 

A Danish pilot programme for medicinal cannabis products was initiated in 2018. Since then, it has been possible to obtain a license to grow cannabis plants in Denmark, in order to use the attained herbal drug in medicinal cannabis products. Export of medicinal cannabis is also allowed. Alternatively, cannabis products from other countries can be imported to Denmark.

The pilot programme was renewed in January 2022.

The products are exempted from a marketing authorisation. However, detailed requirements are set for product quality, product information, and manufacturing licenses ensuring compliance with GACP and GMP. The field is constantly evolving at a national and international level; both the Applicants and the Agency are gradually gaining more and more experience, trying to navigate with limited harmonization within the EU.

The presentation will focus on regulatory challenges related to the quality requirements for the products.

E.g.: What kind of active ingredients are allowed? Can homogeneity be ensured? Is it acceptable to decarboxylate cannabis? To irradiate? How should the products be declared? How to deal with stability? What quality requirements should be set for imported products?

Dr. Andreas Ziegler, ZIENCE – Exchange of Ideas

Extemporaneous medicinal cannabis preparations in Germany (framework – experiences – problems) 

The processing of cannabis and cannabinoids in compounded preparations is a particular challenge for pharmacies, since the relevant manufacturing techniques are very specific and hardly ever occur in other compounded preparations. At the same time, this special kind of pharmaceuticals and its specific implications are largely unknown for many companies, as they are often familiar with the processes of industrial production, but not with drug preparation in pharmacies, for which special legal regulations apply. However, considering that in 2021 78% of all cannabis prescriptions dispensed in Germany were compounded preparations, the importance of this type of medicinal preparation is enormous for the cannabis sector. In order to contribute to a better understanding of this special drug class, the most important aspects of the legal framework will be presented in this lecture. Common problems arising in everyday work for both parties – pharmacies and industry – will also be discussed, as well as conclusions that can be drawn from 5 years of experience with cannabis in compounding.

Prof. Dr. Markus Veit, Alphatopics GmbH

Quality requirements for medicinal cannabis products in Europe

Regarding the quality of medicinal cannabis (flowers, preparations, medicinal 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 the 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. In the presentation the most important requirements and areas of conflict will be discussed.

Henrike Otting, Federal Institute for Drugs and Medical Devices, Bonn, Germany

The German Cannabis Agency – federal institution, pharmaceutical company and wholesaler

Following a change in policy, a new regulatory framework for medicinal cannabis came into force in Germany in 2017. In line with the provisions of the Single Convention on Narcotic Drugs, the German Cannabis Agency was established to direct and control the cultivation, production and distribution of medicinal canabis grown in Germany. Meanwhile, medicinal cannabis cultivated in Germany by three different contract partners of BfArM is distributed and available to patients with individual prescriptions. It is a particular experience to act as pharmaceutical company and wholesaler within the structure of a federal institution.

Dr. Reinhard Kerker, GMP Inspector, RP Tübingen

Classification, GMP requirements and supply chain for medicinal cannabis products

What is the correct classification of medical cannabis products? Starting material, active ingredient, bulk drug or finished medicinal product, nothing like that or maybe all of them? The authorities and inspectorates outside the continent, in European countries and the German federal states could have different views. Based on this, there are different requirements: GACP, GMP Part I or II, marketing authorisations; written confirmation or third-country inspection. Which sales channels and supply chains are established in the German market? Are there any court cases and changes based on them? What developments may be expected in Germany?

Within the scope of the lecture, an attempt will be made to answer these questions and further questions from the participants from a pharmacist‘s and GMP inspector‘s point of view

Dr. Dirk Lachenmeier, CVUA Karlsruhe

Regulatory challenges of low-THC cannabis products 

According to EMCDDA, the increase in the open sale of cannabis products in Europe has raised questions around the possible legal and commercial status of these products. The products are marketed for their low THC (tetrahydrocannabinol) content, which sellers claim exempt them from control by narcotics laws, or as sources of CBD (cannabidiol). On the other hand, legal forms of low-THC cannabis products include medicinal products available on prescription in pharmacies. However, most products for oral consumption are marketed OTC as food supplement, cosmetic, food flavour or even non-food, such as room fragrances or animal feeds, mostly to circumvent legal requirements, such as mandatory novel food approvals. Another group of products increasingly found on the market are low-THC variants intended for smoking (CBD-flowers) or vaping (CBD-containing liquids).

Apart from the general question on the legality of sale to the end consumer, the product group raises questions regarding safety, as some products may exceed toxicological thresholds for THC, such as the acute reference dose (ARfD) or even the lowest obeserved adverse effect level (LOAEL). Concerns about possible toxicity of chronic CBD exposure have also been raised.

This presentation will provide current examples from the practice of an official control laboratory with reference to the most recent court cases on low-THC cannabis and CBD in the area of lifestyle consumer products.

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Attendance fee online: € 950.- plus VAT per trained person

You can view all the presentations described via the recording link, in one piece or in parts whenever your schedule allows. You will receive a personalised access code, a certificate of attendance and the lecture documents as printable PDF documents.

If you are only interested in individual lectures, please contact us. We will make you a personal offer.

10% discount: For simultaneous registration of several persons from a single company. We are also happy to offer you and your team attractive special prices for groups. Please contact us.