Legal Disclaimer: The information provided on this document does not, and is not intended to, constitute legal advice; instead, all information, content, and materials available in this document are for general informational purposes only. Information in this document may not constitute the most up-to-date legal or other information. This document contains links to other third-party websites. Such links are only for the convenience of the reader. All liability with respect to actions taken or not taken based on the contents of this document are hereby expressly disclaimed. The content on this posting is provided "as is;" no representations are
made that the content is error-free.
The following shall provide an overview of the regulatory steps necessary to import medical cannabis (MC) from non-EU countries to Germany. Due to the dynamic nature of this evolving industry and its legal and regulatory bilateral complexity, please consider this only for general informational and non-binding purposes.
Overall, it is a resource -/ and time-intensive process. It will require to comply to both the country of origin and German, and partly evolving, pharmaceutical regulatory regime. While the EU and German legal MC sector enjoys global attention to its immense growth and profit potential, many nations, especially in the emerging markets, are unlikely to fulfil the compliance hurdles (any time soon) due to their lack of GMP standards, poor track record of complying to safety, health and counterfeit hurdles.
So far, only two nations have been approved to supply shelf-ready medical grade cannabis for Germany, which are Canada and Netherlands. Australia has been approved to supply MC samples for initial testing research purposes already. Other nations, such as Portugal and Israel are probably to follow suit soon.
Country of Origin requirements
Hold respective federal, state or territory license and permit for cultivation and production (e.g. ODC for Australia)
Export license for country of Origin
Country of Origin needs to be a signatory nation to the Single Convention on Narcotic and Drugs 1961 (excludes US)
Possibly AMRadV-compliance if MC plants are radiated / ionized for pest control
German Import Authorisation by BfArM
"Basically, MC can be imported from any state that grows cannabis for medical purposes under state-sanctioned control & supervision, and that can offer medicinal-quality cannabis. The German Federal Institute for Drugs and Medical Devices (German: BfArM) will grant companies interested in importing medicinal cannabis flowers the necessary permits and approvalsas soon as possible upon request and if the requirements are met."
According to Appendix III of the Narcotics Act (BtMG), MC can be marketed and prescribed in Germany that comes from a cultivation that is used for medical purposes under state control in accordance with Articles 23 and 28 paragraph 1 of the 1961 Single Convention on Narcotic Drugs. This means that only MC that has a recognized medical purpose in the country of origin and is subject to control there in accordance with the aforementioned international legal requirements, on the basis of a BfArM permit pursuant to Section 3 (1) BtMG for medical care for the population imported to Germany. If the legal requirements are met, the BfArM grants the import licenses and permits requested by the market participants.
In addition, the qualitative requirements for medical cannabis are regulated by German pharmacy law, the German Drugs Act (GER: AMG). The state authorities involved in the monitoring and examination of medicinal products are responsible for the examination, determination and compliance with the pharmaceutical regulations regarding the import of medical cannabis.
1) Country of origin is UN Signatory
Under the Single Convention, cultivation for medicinal purposes can only occur under licence issued by the respective Government. Permits allow the Government to restrict how much is cultivated (and manufactured), thus meeting a key obligation of preventing accumulation of narcotic material.
2) EU-GMP Certificate
A Good Manufacturing Practice ("GMP") certificate is required in accordance with the rules governing medicinal products in the European Union ("EU"). The EU GMP certification is awarded by the German competent agency, the Authority for Medicines (GER: Arzneimittelbehörde).
EU GMP standards for pharmaceuticals are among the most rigorous in the world, demanding the highest levels of quality assurance and product consistency. Usually following a pre-audit review by a local compliance Auditor, a comprehensive inspection is conducted over a 4-day period by government officials from the responsible agency at the Company's facility.
Requirements for the microbiological quality of herbal medicinal products, e.g. B. cannabis flowers are specified in the European Pharmacopoeia. These requirements can be met either by defined cultivation and manufacturing conditions and/ or by treatment with ionizing radiation.
Medicinal products that are treated with ionizing radiation to reduce the number of germs require approval by the responsible federal government to place them on the market in accordance with section 1 (2) sentence 1 number 4 of the Ordinance on Radioactive Medicinal Products Treated with Ionizing Radiation (AMRadV).
4) German Import Authorisation
The German Federal Institute for Drugs and Medical Devices (German: BfArM) will grant companies interested in importing medicinal cannabis flowers the necessary permits and approvals as soon as possible upon request and if the above requirements are met