10 Q&A’s related to Medical Cannabis in Germany
In this article you can expect a market overview of the medical use of cannabis in Germany.
In particular, we discuss the legal situation, licensing and regulatory questions, distribution and, most recently, future business areas.
1. Is medical cannabis legal in Germany?
In 2017, the German legislator amended national narcotic laws and other related provisions legalizing the growth, distribution and consumption of cannabis for medical purposes. These provisions now enable doctors to prescribe medical cannabis on the basis of a medical prescription. In the course of this change in the law, the legislator also created corresponding guidelines and bodies to regulate this process from the cultivation up to the distribution to patients. However, it should be noted that cannabis is still classified as a narcotic drug as well as a pharmaceutical and is therefore only marketable in Germany under the specific legal conditions described below.
a.What are the licensing requirements to grow medical cannabis in Germany?
As cannabis is a non-marketable narcotic, the cultivation of cannabis is subject to authorization. This general principle has been confirmed various times by German Supreme Courts (BVerfG, Order of 09-03-1994 - 2 BvL 43/92; BVerfG, Order of 01-091994 - 2 BvQ 33/94; BVerwG, Judgment of 21-12-2000 - 3 C 20/00).
With the Act on the Amendment of Narcotic Drugs and Other Regulations (BtMRÄndG), which came into force on 10 March 2017, the legislator however has expanded the possibilities for growing and prescribing cannabis drugs. As a contracting state, Germany has complied with the requirements of Articles 23 and 28(1) of the 1961 United Nations Single Convention on Narcotic Drugs. According to this, a contracting state which permits the cultivation of THC-rich cannabis for medicinal purposes must establish a state agency which approves the cultivation and to which all growers must deliver the entire harvest. For this reason, Germany has created the Cannabis Agency (in German “Cannabisagentur”, a subdivision of the Federal Institute for Drugs and Medical Devices - BfArM), which controls cultivation, harvesting, processing, quality control, storage, packaging and distribution to wholesalers and pharmacists or manufacturers.
The Cannabis Agency issues tenders in a Europe-wide government bidding process for the quantities of cannabis to be procured for medical purposes in accordance with the relevant thresholds of Part 4 of the Act against Restraints of Competition (GWB). In this respect, the Cannabis Agency awards contracts to growers in Germany for the supply of cannabis and concludes supply or service contracts under civil law with them. The invitation to tender and the contracts with the growers include in particular the type and quantity of cannabis required for medical purposes. The successful bidders are obliged to fulfil on their own responsibility their performance obligations arising from the award of the contract and the subsequent supply contract, to organise the cultivation as well as the harvest etc. and to apply for the official approvals required for this (in particular a narcotics law permit to participate in narcotics traffic according to sec 3, i.e. a growing permit). The procedure will be carried out by the Cannabis Agency as layed out in sec. 19 (2a) of the German Narcotic Drugs Act (BtMG).
According to sec. 3 of the German Narcotic Drugs Act (BtMG) a licence issued by the Federal Institute for Drugs and Medical Devices (BfArM) shall be required for those who grow, manufacture, trade with narcotics, or – without trading with them - import, export, transfer, sell, otherwise market, or acquire them.
The applicant has to provide specific documentation, e.g. proof that the persons in charge have the required expertise, or a description how the facility is secured against unauthorized removal of narcotic drugs. Application requirements are fully listed in sec. 7 of the German Narcotic Drugs Act (BtMG).
Because cannabis is only cultivated for medical purposes and is therefore considered to be a medicinal product within the meaning of sec. 2 of the German Medicinal Products Act (AMG), the cultivator also has to obtain an authorisation to manufacture medicinal products according to sec. 13 of the German Medicinal Products Act (AMG). Therefore, any commercial or professional producer of cannabis as a medicinal product requires an authorisation from the competent authority according to sec. 13 para. 4 of the German Medicinal Products Act (AMG). The decision on the granting of the authorisation shall be reached by the competent authority of the federal Land where the factory site is situated or is to be situated.
In terms of personal and material requirements, the bidder has to provide proof of the required expertise, which, according to sec. 5 (1) No. 1 of the German Narcotic Drugs Act (BtMG), in the case of production (including the cultivation) of narcotic drugs in form of medicinal products, must be provided by proof of the required expert knowledge in accordance with sec. 15 (1) of the German Medicinal Products Act (AMG). The permission granted by the Cannabis Agency are hence tailored to a circle of bidders with industry knowledge and professional experience, as evidenced by its suitability and contract requirements. Once the approval has been granted, the manufacturer must take the necessary safety measures (sec. 15 BtMG), keep ongoing records (sec. 17 BtMG) and provide notifications (sec. 18 BtMG) to the competent authority.
Regarding the requirements for the growing process itself, cannabis must be cultivated in accordance with the Good Agricultural and Collection Practice (GACP), an annex to the European Union – Good Manufacturing Practices (EU-GMP), and meet the requirements of the Cannabis Flower Monograph (German Pharmacopoeia / Deutsches Arzneimittelbuch - DAB). The guidelines on the cultivation process are very comprehensive and must fully be taken into account by the approved bidders.
Besides domestic cultivation, supply of patients with cannabis products will be covered by imports requiring several licenses and authorizations according to Narcotic Drugs Law and Medicinal Products Law (for further information on import/export see below sec. c). The Cannabis Agency, however, is not responsible for the import of cannabis and will therefore neither buy nor distribute imported cannabis. This falls within the competence of the Federal Opium Agency.
The first successful tender procedure has been completed in May 2019. The tender covers a total of 10,400 kg of cannabis, spread over four years with 2,600 kg each. It is divided into 13 lots of 200 kg per year. This means that the first contract has been awarded for the cultivation and harvesting of a total of 7,200 kg of cannabis. The first harvest is expected for the fourth quarter of 2020. The total production will be bought up by the Cannabis Agency and subsequently resold without profit (sec. 19 (2a) sent. 3 of the German Narcotic Drugs Act (BtMG)) to pharmaceutical manufacturers, wholesalers and pharmacies holding the required licenses. Until the next bidding process is initiated, the growing of cannabis remains reserved only for those that have been already selected by the Cannabis Agency.
For the sake of completeness, please note that in the past in Germany under very special circumstances it was possible to receive a licence for self-growing and use of cannabis for medical reasons. In 2016 the Federal Administrative Court ruled that the claimant suffering from multiple sclerosis is permitted to self-grow cannabis because it was shown that there were no treatment alternatives and the purchase of cannabis in the pharmacy was unaffordable for the claimant (BVerwG, judgment of 6-4-2016 - 3 C 10/14). However with the Act on the Amendment of Narcotic Drugs and Other Regulations (BtMRÄndG) in 2016 the narcotics law changed in such a way that a licence is no longer necessary for these patients.
b. What are the licensing requirements to manufacture cannabis for medical use in Germany?
After cultivation, the Cannabis Agency resells the medical cannabis to manufacturers of cannabis drugs, wholesalers or pharmacies, among others. The Federal Institute for Drugs and Medical Devices - BfArM) sets its ex-factory price for this purpose. The personnel and material costs incurred by the BfArM are to be refinanced via a surcharge covering these costs. The BfArM is not allowed to make any profits or surpluses.
Because cannabis is considered to be a medicinal product, manufacturers must obtain the necessary licence for dealing with narcotic drugs and comply with the relevant provisions throughout Narcotic Drugs Law and Medicinal Products Law. This includes – similar to the prerequisites for cultivation – the application for a licence for dealing with narcotic drugs according to sec. 3 and 7 of the German Narcotic Drugs Act (BtMG). However, in contrast to the cultivation, the Federal Opium Agency is soley responsible for the narcotic aspects of the manufacturing of cannabis products. In this regard, applicants should take into account the application notes available on the homepage of the Federal Institute for Drugs and Medical Devices (BfArM) specifically for manufacturers. Furthermore, the manufacturing of cannabis products is subject to Medicinal Products Law and must be carried out in accordance with the German Medicinal Products Act (AMG) as described above (see above under a.).
c. What are the licensing requirements to distribute medical cannabis to other re-sellers in Germany?
Narcotics may only be distributed and re-sold on the market to persons or entities in possession of a licence to purchase narcotics in accordance with sec. 3 of the German Narcotic Drugs Act (BtMG) or entities which are excluded from the licensing requirement according to sec. 4 of the German Narcotic Drugs Act (BtMG), such as pharmacies. This follows from sec. 12 (1) of the German Narcotic Drugs Act (BtMG).
Regading the “distribution itself”, there are no specific requirements; wholesalers or distributors must, however, meet the requirements described above and obtain the necessary licence for dealing with narcotics according to sec. 3 of the German Narcotic Drugs Act (BtMG) as well as further authorisations and comply with the relevant provisions throughout Narcotic Drugs Law and Medicinal Products Law.
In cases where the cannabis product is considered to be a so called “finished medicinal product” (in German: “Fertigarzneimittel”) as defined in sec. 4 of the German Medicinal Products Act (AMG), the distributor is obliged to acquire a marketing authorization for this specific product according to sec. 21 of the German Medicinal Products Act (AMG). The placing of such a cannabis product on the German market may be prohibited as an unfair competition practice in case there is no marketing authorization for the specific product in place. As a consequence, such products have to go through the entire marketing approval process and, hence, extensive clinical trials like any other finished medicinal product prior to placing them on the German market. In its decision dated Augsut 2, 2018, the Higher Regional Court in Düsseldorf (15 U 21/18) has clarified that, under specific circumstances, cannabis based products may be classified as finished medicinal product and therefore require an authorisation for them to be placed on the market. In the case at hand, the cannabis product was only distributed as a component for the manufacture of magistral medicinal preparations (in German: “Rezepturarzneimittel”) to pharmacies. According to the court, the classification of a finished medicinal product particularly depends on the manner the product is presented on the market. If, for example, the product is distributed with a child-proof packaging, its appearance alone indicates that such a product is not merely intended as a component for the manufacture of magistral medicinal preparations, but appears as a finished medicinal product. If products are only intended as a manufacturing component for pharmacies, distributors should therefore take great caution to ensure that their products are not presented as a finished medicinal product.
Companies engaging in the wholesale trading of medical cannabis must in addition obtain an authorization to do so under sec. 52a of the German Medicinal Products Act (AMG), just as needed for trading of any medicinal product.
Anyone wishing to import or export narcotic drugs is, in addition to the required license for dealing with narcotics according to sec. 3 of the German Narcotic Drugs Act (BtMG) as described above, required to apply for an import or export license at the Federal Institute for Drugs and Medical Devices (BfArM) according to sec. 11 of the German Narcotic Drugs Act (BtMG). Licences for import shall be issued after an import application has been submitted in accordance with sec. 1 of the German Narcotics Foreign Trade Regulation (BtMAHV), for export after an export application has been submitted in accordance with paragraph 7 of the German Narcotics Foreign Trade Regulation (BtMAHV).
Anyone wishing to import medical cannabis on a commercial or professional basis from countries that are not member states of the European Union or other signatory states to the Agreement on the European Economic Area (“third countries”), requires permission from the competent authority according to sec. 72 of the German Medicinal Products Act (AMG), just as needed for the import of any medicinal product. In this regard it is important to note that such an import authorisation only covers the “customs authorization” and therefore, if the product is also classified as a “finished medical product” within the meaning of the statute, must be combined with a marketing authorization under sec. 21 of the German Medicinal Products Act (AMG).
d.Can medical cannabis be distributed to consumers in Germany directly?
Medical cannabis may not directly be distributed to consumers. Cannabis is cultivated intended exclusively for medical purposes and is therefore a medicinal product.
Therefore it may only be prescribed by a doctor according to a strict indication. Please note that the prescription of cannabis by dentists and veterinarians is not permitted as there is no medical evidence of a dental or veterinary application.
From a legal point of view, the doctor must in particular take into account the existence of the requirements of sec. 13 (1) sent. 1 and 2 German Narcotic Drugs Act (BtMG) applicable to all other prescription drugs. Accordingly, the prescription of narcotic drugs described in BtMG is only permitted if the physician is convinced on the basis of his or her own examination that the use is permissible and necessary according to the recognized rules of medical science. However pursuant to sec. 13 (1) sent. 2 BtMG, the application is not justified in particular if the intended purpose can be achieved by other means, for example by therapy with a drug that is not an anaesthetic. The permissible prescription of an anaesthetic therefore presupposes that the doctor not only makes a concrete diagnosis and a corresponding indication for treatment, but also that other forms of therapy are not suitable.
Please note that the maximum amount of cannabis a doctor may prescribe for a patient within 30 days has been limited to 100,000 milligrams. This was derived from experience gained by the Federal Institute for Drugs and Medical Devices (BfArM) within the framework of the exemptions for patients required under previous narcotic drug legislation to purchase the monthly quantities of cannabis required for medical purposes in the form of dried flowers from pharmacies. Since different disease patterns and indications can be treated with different varieties of standardized cannabis for medical purposes, which may differ in THC content, the maximum prescription quantity was set independently of THC content for ease of use.
In addition, pursuant to sec. 13 (2) sent. 1 BtMG, the supply of cannabis is only permitted through pharmacies on presentation of a special prescription for this purpose. Pharmacies distributing cannabis must do so in accordance with the usual requirements for narcotic prescriptions, particularly sec. 9 and 12 of the Narcotics Prescription Ordinance (BtMVV).
In strictly limited exceptional cases, SHI insured persons have a right to be supplied with cannabis drugs in the form of dried flowers or extracts and to be supplied with drugs containing the active ingredients dronabinol or nabilone. However, according to sec. 31 (6) sent. 2 Social Insurance Code (Fünftes Buch Sozialgesetzbuch - SGB V), the approval of the health insurance company must be obtained before starting a therapy with cannabis as a flower or extract in or with drugs containing the active substances dronabinol or nabilone.
e.What are the limitations on purchasing and marketing medical cannabis in Germany?
Medical cannabis may not be purchased directly by consumers (see above under d.) as it is classified as a narcotic. Narcotics may only be purchased by persons or entities in possession of a licence to purchase narcotics in accordance with sec. 3 of the German Narcotic Drugs Act (BtMG). This follows from sec. 12 (1) of the German Narcotic Drugs Act (BtMG).
Medical cannabis may not be advertised to end consumers, but to healthcare professionals only, sec. 14 of the German Narcotic Drugs Act (BtMG).
Further, the German Ordinance on the Price of Medicinal Products (Arzneimittelpreisverordnung - AMPreisV) applies to price formation via sec. 78 of the German Medicines Act (Arzneimittelgesetz - AMG), so that for cannabis which is produced in advance and placed on the market in a package intended for sale to the consumer, the price ranges for finished medicinal products apply to wholesalers and pharmacists. For other forms of cannabis, the surcharges provided for in the AMPreisV also applies.
f. Which regulations are there around potency and formulation of drugs containing cannabis in Germany?
Medical cannabis must be cultivated in accordance with the Good Agricultural and Collection Practice (GACP) for Starting Materials on Herbal Origin, an annex to the European Union – Good Manufacturing Pracices (EU-GMP), and meet the requirements of the European Pharmacopoeia and the Cannabis Flower Monograph, which is part of the German Pharmacopoeia (Deutsches Arzneimittelbuch – DAB, published in the German Federal Gazette of 12.05.2017, p. 1-9). The Pharmacopoeia is a collection of recognized pharmaceutical rules regarding the quality, testing, storage, dispensing and designation of medicinal products and the substances used in their manufacture, published by the Federal Institute for Drugs and Medical Devices (BfArM) in agreement with the Paul Ehrlich Institute and the Federal Agency for Consumer Protection and Food Safety (sec. 55 (1) of the German Medicinal Products Act (AMG)).
Cannabis will – in general – either be distributed as a magistral medicinal preparation (in German: “Rezepturarzneimittel”) in form of medicinal cannabis flowers (dried flowers of the cannabis plant), as cannabis extract (an extract from components of the female cannabis plant) or as a specific composition of the active substance Dronabinol (THC). The exact recipe instructions for such preparations are laid down in the “New Prescription Form (NRF)”, which is the standard work for drug production in pharmacies and is part of the German Drug Codex (DAC). Additionally, there are two authorized “finished medicinal products” (in German: “Fertigarzneimittel”) containing cannabis on the market, namely Sativex® (thick extracts from cannabis, active ingredient: Nabiximol) and Canemes® (active ingredient: Nabilon).
g. Are there municipal, regional, provincial, or other licenses required
The license to deal with narcotics within the meaning of sec. 3 of the German Narcotic Drugs Act (BtMG) is granted by Federal Opium Agency (a national body).
However, the decision on the granting of licenses and authorisations issued in accordance with Medicinal Products Law, e.g the manufacturing authorisation (sec. 13 (4) German Medicinal Products Act - AMG) shall be reached by the competent authority of the federal Land where the factory site is situated or is to be situated.
2. Is recreational marijuana legal in Germany?
Recreational marijuana is illegal in Germany. Anyone who cultivates, manufactures, trades with, imports, exports, sells, gives away, otherwise puts into circulation, acquires or in any other way procures non-medical cannabis, is punishable under §§ 29 et. seqq. of the German Narcotic Drugs Act (BtMG).
3. Is hemp legal in Germany?
In principle, industrial hemp is legal in Germany. However, according to appendix I (in the section “cannabis”) of the German Narcotic Drugs Act (BtMG) this only applies to hemp plants meeting specific criteria which are laid out in Article 9 of Delegate Regulation (EU) No 639/2014 which do not surpass a certain threshold of THC content. The cultivation of any form of cannabis is subject to very specific rules and requirements which are specified in various regulations and have to be fulfilled by anyone wishing to cultivate or trade hemp throughout Germany.
a. What are the licensing requirements to grow hemp in Germany?
The legal provisions applying for the cultivation of hemp are mainly contained in the Regulation (EU) No 1307/2013 as well as in the German Narcotic Drugs Act (BtMG). Responsible for the legal procedures concerning the cultivation of industrial hemp in Germany is the Federal Office for Agriculture and Food (Bundesanstalt für Landwirtschaft und Ernährung - BLE) and in special cases the Federal Institute for Drugs and Medical Devices (BfArM).
According to appendix I lit. d (in the section “cannabis”) of the German Narcotic Drugs Act (BtMG), the cultivation of hemp is only permitted to either agricultural enterprises which meet the conditions laid down in sec. 1 (4) of the Law on Old-Age Insurance for Farmers (Gesetz über die Alterssicherung der Landwirte - GAL) or to agricultural enterprises who are eligible for aid under Regulation (EU) No 1307/2013. In addition, the cultivation has to be carried out exclusively with certified seeds listed in the Common Catalogue of Varieties of Agricultural Plant Species referred to in Article 9 of Delegate Regulation (EU) No 639/2014.
In general, agricultural enterprises in accordance with sec. 1 (4) of the Law on Old-Age Insurance for Farmers (Gesetz über die Alterssicherung der Landwirte - GAL) are enterprises where the agriculturer is insured with an agricultural old-age insurance fund or has been exempted from the obligation to be insured and is engaged in agricultural activities not only for a very short period of time, but also for the purpose of predominantly planned cultivation of soil plants.
Private individuals who do not exercise agriculture as a profession or not independently do not fulfil these requirements. Furthermore, anyone engaged in forestry, horticulture, viticulture, fish farming, pond farming, beekeeping, inland fishing and transhumance is not allowed to cultivate hemp. Therefore, the cultivation of hemp for the purpose of sale as an ornamental plant is not permitted in Germany, as such would be considered horticulture.
As mentioned above, agricultural enterprises may further be authorized to grow hemp if they are eligible for aid in the form of “basic payments” under Regulation (EU) No 1307/2013. These regulations provide a complex and comprehensive framework and should therefore be reviewed carefully. The detailed rules implementing this procedure can be found in Regulation (EU) No 809/2014 and Regulation (EU) No 639/2014 as well as in the corresponding (national) regulation of support schemes and the Integrated Administration and Control System (InVeKoSV, IACS Regulation) which implements various EU regulations on agriculture.
The cultivation of industrial hemp does not require a permit. But agricultural enterprises wishing to cultivate hemp must notify the cultivation to the Federal Agency for Agriculture and Food, according to sec. 24a of the German Narcotic Drugs Act (BtMG).
The notification must contain:
1. the name, forename and address of the agricultural enterprise and, in the case of a legal person, the name of the agricultural undertaking and the legal representative, 2. the member/register number assigned to the agricultural enterprise by the competent trade association,
2. the variety, accompanied by the official labels, if these have not been submitted to the competent Land authority under the basic premium schemes,
3. the area sown in hectares and ares, stating the area identification number; if this is not available, the cadastral number or other information identifying the area sown which has been recognised by the Bundesanstalt für Landwirtschaft und Ernährung, such as the district, parcel and parcel, may be given.Anyone who does not, incorrectly, or in good time report the cultivation of hemp and does not attach the necessary seed labels, acts in violation of this regulation and may be fined.
The Federal Institute will carry out controls regarding the THC content of the hemp. The Federal Agency also publishes an updated list of hemp varieties which are suitable for permanent cultivation - this list may change in the course of time due to changing THC content values.
According to sec. 28 of the Regulation on the implementation of support schemes and the Integrated Administration and Control System (InVeKoSV, IACS Regulation), growers are also obliged to report the flowering of hemp to the Federal Agency for Agriculture and Nutrition. This provision also determines the exact date of the harvest.
b. What are the licensing requirements to manufacture hemp products in Germany?
The manufacturing of hemp based products is only permitted if the used plants originate from the cultivation in countries of the European Union and were listed as a certified seed in the Common Catalogue of Varieties of Agricultural Plant Species referred to in Article 9 of Commission Delegate Regulation (EU) No 639/2014, or if their tetrahydrocannabinol content does not exceed 0.2 per cent and their marketing (other than cultivation) is exclusively for commercial or scientific purposes that rule out the possibility of intoxication. Hemp is often used in food products and must therefore be manufactured in accordance with the corresponding food regulations (see for further information cannabis based food products the sec. 6 lit. c on CBD).
c. What are the licensing requirements to distribute hemp products to other re-sellers in Germany?
Generally, the same regulations apply as described above in sec. b. Trade in hemp crops originating from the cultivation of certified EU seeds is exempt from narcotic legislation provided that the trade is exclusively for commercial or scientific purposes excluding abuse. The handling of industrial hemp for industrial processing and recycling into paper, insulating materials, fuel, textiles, in which misuse for intoxication purposes is excluded, is therefore excluded from narcotic monitoring. This exemption was created in order to develop the market potential for the hemp plant and a large number of its possible uses for industrial and energy purposes.
The import and export of agricultural products to or from the European Union is, however, partly subject to the presentation of a licence application to the Federal Office for Agriculture and Food (Bundesanstalt für Landwirtschaft und Ernährung - BLE).
d. Can hemp products be distributed to consumers in Germany directly?
Selling hemp plants to the end-consumer for personal consumption is illegal and punishable if abuse for intoxication purposes is not ruled out, e.g. if cannabis plants are sold to cannabis consumers in a flower pot.
e. What are the limitations on purchasing and marketing of hemp products in Germany?
No special regulations apparent. Otherwise see sec. b.
f. Which regulations are there around potency and formulation of products containing hemp?
There are very specific regulations concerning the potency and formulation of industrial hemp. These measures are kept to ensure that illegal crops cannot be hidden among the crops and thereby adversely disturb the market for industrial hemp.
A catalogue of varieties can be obtained through the Federal Office for Agriculture and Food (Bundesanstalt für Landwirtschaft und Ernährung - BLE) listing all varieties permitted for cultivation by European Union law. The catalogue is updated annually.
g. Are there municipal, regional, provincial, or other licenses required?
The Federal Agency for Agriculture and Food (Bundesanstalt für Landwirtschaft und Ernährung - BLE) is responsible for import from third countries, the cultivation license for useful hemp and the implementation of THC controls for hemp cultivation.
However, the necessary declaration of areas used for agricultural purposes required under Article 17 No. 7 of the Regulation (EU) No 809/2014 must be submitted to the competent agricultural office of the states.
4. Is CBD legal in Germany?
The legal status of CBD in Germany is in various aspects unclear. Therefore, the provided answers in the following section should be treated with caution since there is only very little jurisdiction on this matter and there may be recent changes in the public legal opinion.
a. What are the licensing requirements for the cultivation of CBD in Germany?
As CBD is produced from cannabis plants, the growing of these plants must be in accordance with the regulations for either cultivating (industrial) hemp or medical cannabis (see above). Cannabis cultivated for medical purposes under the supervision of the Cannabis Agency can also be used to manufacture CBD based medicines.
b. What are the licensing requirements to manufacture CBD products in Germany?
CBD is not listed in the German Narcotic Drugs Act (BtMG) Annexes as an individual substance that does not have an intoxicating effect and is therefore not a narcotic within the meaning of the BtMG. However, according to letter (b) under the heading Cannabis in Annex I to Paragraph 1(1) of the German Narcotic Drugs Act (BtMG), plants and parts of plants belonging to the genus Cannabis are only excluded from the narcotic regulations if they originate from cultivation in countries of the European Union with certified seeds (useful hemp) or if their content of THC does not exceed 0,2 % and the trade with them (with the exception of cultivation) serves exclusively commercial or scientific purposes which exclude abuse for intoxication purposes. Therefore, only CBD extracts which do not exceed the THC limit value of 0.2 percent are therefore not subject to the provisions of the German Narcotic Drugs Act (BtMG) are free to manufacture.
Apart from narcotics law, CBD products meant for human consumption are in any case subject to pharmaceutical law as well as food law and may only be produced under specific conditions. From the point of view of the Federal Opium Agency and the Federal Agency for Consumer Protection and Food Safety, products containing CBD are to be classified as a pharmaceutical and hence require a permit to produce according to sec. 13 of the German Medicinal Products Act (AMG) (see further on this above sec. 3 lit. a).
c. What are the licensing requirements to distribute CBD products to other re-sellers in Germany?
Same applies as for the production of CBD described above (see above sec. 6 lit. b).
d. Can CBD products be distributed to consumers in Germany directly?
The purchasing and (re-)selling of CBD containing products without any license, which is has become a common practice in Germany, must be treated with caution and can until today only be carried out under high legal risks. The distribution of CBD is restricted by narcotics law, pharmaceutical law and specific food laws.
In some regions of Germany, the public prosecutor's office and the police have conducted searches of business owners selling CBD based products (“CBD-Shops”). German authorities have repeatedly underlined that the specific regulations for medical cannabis use and industrial hemp should not to be abused to supply consumers with THC-weak preparations for personal consumption purposes (“legal highs”).
According to letter (b) under the heading Cannabis in Annex I to sec. 1 (1) of the German Narcotic Drugs Act (BtMG), plants and parts of plants belonging to the genus Cannabis are only excluded from the narcotic regulations if they originate from cultivation in countries of the European Union with certified seeds (useful hemp) or if their content of THC does not exceed 0,2 % and the trade with them (with the exception of cultivation) serves exclusively commercial or scientific purposes which exclude abuse for intoxication purposes. This also applies to preparations from the plants and parts of plants if they fulfil the aforementioned conditions.
The Federal Institute for Drugs and Medical Devices (BfArM) has stated, that, due to the limitations above, unprocessed or only processed plant parts (e.g. dried and crushed plant material) may not be supplied to the consumer. This does however not apply to all preparations with processed hemp of the above varieties, even if they still contain low THC residues from the parts of the plant. In any case, condition for supply to the end consumer is that misuse for intoxication purposes can be ruled out. If a CBD based product meets these requirements, it can be deemed “legal” in accordance with narcotics law.
Hence, products such as tea, tobacco substitutes or scented cushions made solely from dried and crushed hemp plants may not be sold to the end consumer. CBD extracts which do not exceed the THC limit value of 0.2 percent are therefore not subject to narcotics law. CBD oils, which are very widely common on the market, may therefore be permissible under narcotics law. Regarding cosmetic products made of processed cannabis, distributors of these products must prove that misuse for intoxication purposes can be ruled out. Otherwise, these products may not be sold to the final consumer or imported by private individuals. Products made exclusively from cannabis seeds, however, are legal with regards to narcotic law.
However, even if a products meets the requirements of narcotics law described above, it may not be legally distributable. CBD is considered a pharmaceutical preparation and has recently (October 2016) been included in Annex 1 of the Drug Prescription Ordinance (AMVV). This means that products containing CDB are in many cases subject to prescription under drug law in accordance with sec. 48 of the German Medicinal Products Act (AMG), irrespective of the dose or route of administration.
CBD containing products which do not fall under the provisions mentioned above and are therefore not classified as a pharmaceutical or a narcotic may further be subject to food law regulations. Particularly, extracts of Cannabis sativa L. and derived products containing cannabinoids are considered to be “novel foods” within the scope of Regulation (EU) 2015/2283 on Novel Foods by the representatives of the EU Commission and the authorities responsible for novel foods in the EU Member States requiring a specific license under EU food law. This seems to be the prevailing opinion on the part of the competent authorities and the scientific service to be, but is controversially discussed in the literature and press. If CBD containing products are to be distributed to the consumer directly, these provisions should however be reviewed carefully with the inclusion of the recent legal developments in Germany. Distributors should, however, in any case assume a licence obligation under the Novel Food Regulation.
The Federal Agency for Consumer Protection and Food Safety (BVL) has also derived THC guideline values for cannabinoids in foods. They are intended for orientation for manufacturers and food monitoring. According to a recent study of the Federal Institute for Risk Assessment (BfR), these guideline values are often exceeded. Very high THC contents were for example found in hemp-containing dietary supplements. According to the BfR, almost all samples (94%) exceeded the guideline value.
e. What are the limitations on purchasing and marketing CBD products in Germany?
The marketing of pharmaceuticals is subject to strict regulation under the German Drug Advertising Act (Heilmittelgesetz - HWG). According to sec. 10 para 1 of the German Drug Advertising Act (HWG), CBD, as a prescription-only medicinal product, may only be advertised by doctors, dentists, veterinary surgeons, pharmacists and persons who lawfully trade in these medicinal products.
f. Which regulations are there around potency and formulation of products containing CBD in Germany?
Regarding cannabidiol, there are no specific requirements on potency or formulation. However, all CBD products must comply with the requirements for THC content as described above.
g. Are there municipal, regional, provincial, or other licenses required?
h. What industries have been most impacted by the legalization of CBD and how?
Since the introduction of CBD on the German market, CBD specialised (online) shops can increasingly be found in Germany. However, as described above, the legal situation is still unclear and there have been repeated official interventions regarding the CBD market. It is to be expected that the clarification of legal issues relating to the use of
CBD products will continue and that the market for CBD products in Germany will continue to develop accordingly.
5. What agencies and relevant laws in Germany are responsible for regulating cannabis and cannabis-related products?
The Cannabis Agency (in Geman: “Cannabisagentur”), a sub-unit of the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM), is responsible for monitoring and controlling the cultivation of medicinal cannabis in Germany in accordance with sec. 19 (2a) of the German Narcotic Drugs Act (BtMG).
The Federal Opium Authority, also a sub-unit of the Federal Institute for Drugs and Medical Devices (BfArM), is in charge of regulating the legal trade of narcotics, including cannabis, and issues the necessary narcotic trade licenses in accordance with sec. 3 et. seqq. of the German Narcotic Drugs Act (BtMG).
The Federal Office for Agriculture and Food (Bundesanstalt für Landwirtschaft und Ernährung - BLE) is responsible for the import regulations from third countries, the cultivation declaration for industrial hemp and the implementation of the THC controls for hemp cultivation.
6. Are there any special financial incentives to spur cannabis industry development?
There are no special financial incentives to spur the cannabis industry development in Germany from the government. However, in the private sector, there are some financial incentives aiming to finance cannabis startups and companies. Since these companies still mainly rely on imports of (medical) cannabis and are very limited on the German market, financial incentives have been considerably “slow” in Germany.
7. What are the prospects for adoption or loosening of restrictions?
It is unclear whether recreational marijuana will be legalized in Germany in the foreseeable future. Just recently, two motions for liberalization of cannabis by the neoliberal Federal Democratic Party (FDP) and the Left Party (Die Linke) were rejected in the health committee of the German Bundestag. The Green Party (Die Grünen) has also introduced a bill for a Cannabis Control Act which aims to exclude cannabis from criminal sanctions and instead open up a controlled, legal market for cannabis. A decision on this draft is still pending. However, Angela Merkel’s Christian Democratic Union (CDU) remains a strong opponent of legalization.
8. What do you consider to be the top recent cannabis developments in Germany?
The most important development remains the legalization of medicinal cannabis in 2017. While the use of cannabis for pharmaceutical purposes previously required a special permit from the Federal Institute for Drugs and Medical Devices (BfArM), doctors can now prescribe cannabis flowers and cannabis extracts to seriously ill patients on a narcotics prescription; costs are in general covered by the health insurance. As a result, the demand for medicinal cannabis has tripled during the past two years, creating a new market around the import and trade of medicinal cannabis.
9. Are there special tax considerations related to cannabis commerce in Germany?
There are no special tax regulations concerning the commercial distribution of (medicinal) cannabis in Germany.
10. What do you consider will be the top cannabis developments in the next year in Germany?
Since a possible legalization is still unclear and will most likely not happen under the present government, the development of the legal situation cannot be foreseen. Apart from legal developments, the German cannabis market will most likely grow considerably in the next years and play an important role in pharmaceutical research and medical development and to all businesses involved. Above all, it remains to be seen how the distribution process controlled by the cannabis agency will develop in the future, especially in interaction with private players on the cannabis market.
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