The path from cannabis plant to approved medical product is clearly regulated in Switzerland and Swissmedic monitors every step. From cultivation to processing and documentation: there are clear quality and safety requirements for companies to ensure the best possible product for patients.
Here we give you an overview of the most important requirements from Swissmedic. Ideal if you want to start production or want to ensure that your company meets all the requirements.
With the relaxation of the law in August 2022, Switzerland has officially approved medicinal cannabis. This means that responsibility for licensing, quality control and safety requirements lies with Swissmedic, the Swiss Agency for Therapeutic Products.
Despite the relaxation of the law, cannabis for medical purposes is still a controlled narcotic. Swissmedic therefore requires complete documentation and clear safety measures. Every step, from cultivation to processing and distribution, must be traceable and controlled.This means a great deal of effort for companies, but a clear legal basis and a reliable structure for safe production.
Before a business can cultivate or process cannabis, it needs several permits. The requirements for cannabis focus on two central licenses in particular:
Establishment Licence
This confirms that the business is fundamentally authorised to cultivate, store or process cannabis.
Individual Cultivation License
It is issued for a specific location, a defined amount of cultivation and a defined period of time.
In order to obtain a permit, companies must prove the following:
● a responsible, competent person
● secure, supervised production and storage facilities
● a functioning quality and traceability system
● complete process and batch documentation
● a customer contract for the harvest
● detailed cultivation, harvest and production plans
Swissmedic wants to ensure that no material is lost, misappropriated or gets out of the controlled cycle and thus sets strict rules.
The central part of the regulations concerns the quality assurance of medicinal cannabis. Companies must adhere to strict standards for both cultivation and processing, such as:
GACP - Good Agricultural Practice
Clear principles apply to cultivation:
● controlled and documented cultivation conditions are mandatory
● hygiene and safety concepts must be drawn up and implemented
● Every company needs trained staff
● Standardized harvesting, drying and storage processes follow
● Regular internal checks ensure that standards are adhered to.
GMP - Good Manufacturing Practice
GMP guidelines apply as soon as cannabis is further processed, for example into extracts, oils or pharmaceutical products.
These include:
● validated manufacturing processes
● test methods for quality, purity and active ingredient content
● complete batch documentation
● strict hygiene standards
● continuous quality checks
To ensure that the end product is of pure quality.
Traceability from start to finish
One of the most important Swissmedic requirements for cannabis is complete transparency. Every batch must be fully documented, from seed to finished product.
Mandatory requirements include:
● Harvest reports
● Documentation of all processing steps
● Listing of stocks
● Transportation documents
● Reporting of loss, theft or deviations in cannabis production
Many companies today rely on digital traceability systems to reliably meet these requirements.
The sale of medicinal cannabis is also strictly regulated. Companies are not allowed to sell their products freely, but require additional permits.
Important points to note:
● Import and export are only permitted with a special permit.
● Distribution within Switzerland is only permitted to authorized entities, e.g. licensed pharmacies.
● In Switzerland, few finished cannabis medicines have been officially approved to date.
● Health insurance companies only cover the costs in certain cases, depending on the diagnosis and proof of efficacy.
Despite the strict regulations, the market is growing continuously. Companies that invest in quality, safety and stable processes at an early stage can position themselves successfully in the long term.
The Swissmedic Cannabis Requirements provide a clear, binding framework for the production and processing of medicinal cannabis in Switzerland. They create safety for patients, transparency for authorities and guidance for companies.
Businesses that consistently implement these requirements not only meet the legal requirements, but also contribute to responsible and high-quality care in the medical sector.