In Europe, the production of medical cannabis must adhere to the so-called “Good Manufacturing Practice” standards. Further information can be found here: https://www.bundesgesundheitsministerium.de/gmp.html (https://www.bundesgesundheitsministerium.de/gmp.html)

At present, cannabis is available on prescription and can be prescribed by physicians for therapeutic purposes on a narcotic prescription; in doing so, requirements under drug and narcotic law must be complied with. Medical cannabis is prescribed in the form of dried flowers and extracts as well as medicinal products with the active ingredients dronabinol and nabilone. The G-BA (Federal Joint Committee) is currently working on a revision of the Pharmaceutical Directive, in which the specifications for prescribing are laid down.

In December 2022 we launched our own premium medicinal cannabis brand ‘AMICI’. Our product line consists of the two types ‘Strawberry Banana’ and ‘Cherry Pie’. The products feature high microbiological purity and come from GMP-controlled indoor cultivation facilities. We are planning to expand our product portfolio in the near future to offer more options to our customers.

We as Cansativa would welcome the possibility of further product forms. This way the potential health benefits of cannabis could be studied better, and the cannabis market could develop in an innovative way. But it is still an open question what product diversity will look like exactly in the recreational cannabis market.Currently, only dosage forms for smoking, inhalation, nasal, and oral intake have been discussed. It has also been established that synthetically produced cannabinoids will not be approved.

The German Government presented a new key issues paper in April 2023 on the controlled distribution of recreational cannabis for adults with a two pillar plan which postpones the original legalization timetable. Instead of one extensive legalisation plan, cannabis is to be legalized in two separate draft legislations consecutively.

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The 1. pillar consists of decriminalization and legalizing the personal consumption and cultivation of up to three plants and the set-up of non-profit community clubs. The draft legislation is expected to be presented before the parliamentary summer break of 2023. The Ministers envision a swift implementation for this first pillar, within this year.

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The 2. pillar concerns regional scientifical pilot projects with commercial supply chains that will be limited to a five-year period for opt-in cities and regions. There are still a lot of specific details missing regarding implementation and scope. The draft legislation is scheduled for after the parliamentary summer break and requires the approval from the European Commission through the Notification Procedure. Due to this process the law is envisaged to be implemented in the third quarter of 2024.

Currently, only pharmacies can buy cannabis products from Cansativa. In a legalized market, we will also distribute our products through all types of licensed dispensaries.

So far, no specific plans have been made regarding the regulation of recreational cannabis.The Cannabis Agency is responsible for medical cannabis and came into being in the context of the 1961 UN Single Convention on Narcotic Drugs. It is possible that the Cannabis Agency or the Federal Institute for Drugs and Medical Devices will also assume responsibilities with regard torecreational cannabis.

At this point in time, there are no significant changes to road traffic regulations planned in relation to legalization. However, there are proposals to adjust the current limits in order to prevent issues with road traffic and in the judiciary due to the current low limit of 1.0 nanograms of THC per milliliter. It is yet to be determined how this adjustment will be implemented.

So far, only some content-related requirements are being discussed, e.g.

• Proof of the required reliability of the applicant or the person entrusted with the management of the business,
• Proof of the required reliability of the persons who have access to cannabis plants
• or products made from them,
• Proof of the required expertise of the applicant or the person in charge of the business,
• Proof of entry of the beneficial owner in an EU company register,
• Proof of sufficient financial resources in relation to the scope of the license applied for.

It is likely that the process for licensing will be developed by both the federal government and the individual states. The regulations for these certificates have not yet been officially established. At this time, one should not be paying for any courses related to obtaining these licenses.

It is conceivable that the currently applicable production conditions for medicinal cannabis will provide a strong guidance, although precise estimates are difficult to make at this time. In any case, there will be strict quality standards, which will probably be based on those for medical cannabis in a weakened form.

Protected and secure storage is expected to be outlined in detail in the final legalization law. However, it is currently unclear what specific regulations will apply to the safeguarding of the products.

The price of legal cannabis will be set to compete with the illicit market in order to discourage consumers from purchasing illegal products. The current price of illicit market cannabis is around 10 euros per gram.

The exact regulatory framework is still uncertain. What requirements will ultimately be imposed on companies depends in part on whether cannabis will continue to be part of the Narcotics Act (BtMG) after legalization. In order to prevent mixing with the black market, exhaustive documentation of the entire supply chain with the help of a track and trace system is likely.

The sale of cannabis will likely take place through licensed, officially approved, and supervised stores, which could include pharmacies. While the specific licensing requirements are currently under discussion,the exact regulations can only be determined once the law is finalized. Additionally, employees will be required to receive specialized training in order to be able to sell cannabis. The training requirements are also currently being discussed, and the specific regulations will be outlined in the final law.

Cansativa has been involved early on with this critical phase of legalisation and we are in constant exchange to raise awareness of the issue of potential shortages.

Existing proposals often only envisage products from national production, even though it is unlikely that German cultivation will be able to meet the expected demand for cannabis of a regularmarket launchin the short term. Therefore, international trade relations and the German-European supply chain should also be strengthened, and importation should be made possible.

In the future, specialty stores will play a decisive role in providing information and advice. However, the exact nature of this advice and the preventive measures to be taken by staff have not yet been specified. Conceivable measures include mandatory age checks, regular staff training, and mandatory information materials.

Currently, most products for therapeutic application come from Canada, Spain, Portugal, Denmark, the Netherlands, Uruguay and Australia. At the moment the goal is to meet the demand for recreational cannabis through domestic cultivation only, as international trade is unlikely to be possible due to EU and international law. The final draft of the law and its approach to retail chains is yet to be determined. 

This greatly depends on the type of legalization. At the beginning of legalization, it is likely that online distribution will not be permitted. However, in the long term, regulations could potentially be adapted to create thenecessary conditions for online distribution.

Consumption in dispensaries will probably not be possible for the time being, as dispensaries are not intended to encourage consumption. Nevertheless, as regulations may change over time, it is possible that the provision of separate designated spaces for consumption within dispensaries will be allowed.

We assume that recreation/consumption clubs will be created; however, regulated dispensing is currently only being discussed in regard to licensed specialty stores.

So far, it can be assumed that the legislator will also regulate the procurement process of companies. The entire supply and trading chain, as well as the granting of licenses, will be subject to government controls. However, we do not currently expect any restrictions with regard tothe selection of a licensed supplier (e.g. exclusively from wholesalers).

No, the commercial marketing of homegrown products is not expected to be possible in Germany. However, the German government plans to allow home cultivation of up to three plants for exclusively private purposes.

At the moment, this is still unclear. It is probable that training courses will be offered mainly for employees at the dispensaries. Possible contents relate to general knowledge of cannabis, addiction prevention and early detection of risky patterns of use, counselling, and educational services, as well asyouth protection.

In addition to public agencies such as substance abuse prevention centers, chambers of commerce, and consumer protection centers, state-licensed private companies could also offer and conduct the training.

We expect that active participation in a training tailored to German legalization will be a prerequisite for obtaining the qualification and cannot be replaced by American training.