TerraLex Cross-Border Guide to Cannabis Guide

According to Sec. 27 Narcotic Drugs Act (Suchtmittelgesetz, BGBl. I Nr. 112/1997) purchasing, possession, production, processing, consumption and distribution of cannabis or marijuana (as defined in Annex I of the Administrative Act on Narcotic Drugs, Suchtgiftverord- nung, BGBl. II Nr. 374/1997) is illegal in Austria.

Though the distribution of cannabis for medical purposes to consumers is not permitted, the distribution of preparations made from cannabis extracts that are approved as proprietary medicinal products or isolated delta-9-THC for extemporaneous preparations with a purity of over 95% (magisterial preparation) is permitted.

Currently, five pharmaceutical preparations containing cannabis active ingredients are approved and commercially available in Austria (Sativex, Nabilone, Cesamet, Canemes, and Epidyolex).

Any physician can prescribe a magisterial preparation via a narcotic prescription.

According to the Narcotic Drugs Act the cultivation of cannabis plants for the purpose of obtaining narcotic drugs for the pro- duction of pharmaceuticals as well as related scientific purposes is only permitted to the Austrian Agency for Health and Food Safety GmbH (AGES) or a subsidiary established for this purpose.

As a processor of raw materials for the manufacture of pharmaceutical products containing ingredients such as dronabinol (THC) or other cannabinoids, you must apply for a number of licenses specified in various federal laws:

For the manufacture and wholesale of medicinal products, a commercial license in accordance with § 94 Z 32 GewO 1994 is required, which is issued by the locally competent trade authorities. The granting of a commercial license in Austria requires the appointment and approval of a commercial representative. The commercial law representative must have certain technical knowledge and have passed an aptitude test.

In addition, approval is required in accordance with § 63 of the Pharmaceutical Act (Arzneimittelgesetz, BGBl. No. 185/1983) by the Federal Office for Safety in Health Care (BASG). The latter must carry out an inspection and approve the operating facility.

For the manufacture of medicinal products containing active ingredients from cannabis, a further authorization is required in accordance with Section 2 of the Administrative Act on Narcotic Drugs, which is granted by the Minister of Health.

Needless to say the applicable rules demand for a wide range of reporting duties, production standards and safeguard measures in the context of manufacturing and the wholesale of pharmaceuticals (containing derivatives).

Cannabis may only be distributed and re-sold on the market by entities, which hold a license for manufacturing and wholesale of pharmaceuticals. The legal requirements for this type of license are described under Clause 1.2 above.

Cannabis may only be distributed for processing purposes to certain defined governmental agencies, scientific institutions and pharmacies.

Pharmaceutically manufactured products require governmental approval before they can be distributed in Austria. Various types of admission procedures exist, depending on the purpose of the pharmaceutical and the scope of the approval.

For the import of pharmaceuticals to Austria, different administrative procedures apply. Products from non-EEA member states, which are not yet approved by the European Medicines Agency (EMA) are treated differently than approved products from other EEA member states.

Entities vested with a license to manufacture pharmaceuticals containing cannabis effective ingredients (Section 2 of the Administrative Act on Narcotic Drugs) may also import cannabis. The import also requires the consent of the Minister of Health.

The distribution of pharmaceuticals containing cannabis active ingredients directly to the consumer is limited to pharmacies. Therefore, a license (concession) to run a pharmacy is required based on the Pharmacy Act (Apothekergesetz, BGBl. Nr. 185/1983). These licenses are amongst other premises subject to territorial re- strictions. A license is granted solely to natural persons vested with a pharmacy diploma. Pharmacies are exempt from the requirement of a separate trade law license for the production of pharmaceuticals and narcotics when preparing medicines within the scope of normal pharmacy operations (e.g., magisterial preparations).

As pointed out before the distribution of cannabis in its raw form directly to consumers is illegal, whereas the distribution of processed cannabis effective ingredients for medical purposes is allowed.

While specific daily maximum amounts are defined for many narcotics in the Administrative Act on Narcotic Drugs, the dosage for cannabis-based medications is not. It is based on science and experience in medical, dental, or veterinary science, particularly for pain relief, withdrawal, and substitution treatments.

The advertisement of pharmaceuticals involves strict limitations. For prescription-only medicines (which includes all cannabis-based medications), advertising to the general public is prohibited. For other pharmaceuticals, advertisements must be explicitly labeled and carry specific mandatory disclosures.

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Since cannabis and cannabis effective ingredients may legally only serve medical purposes, the pharma industry has seen some impact. Since the cannabis cultivation is monopolized by the government there exists no industry in this respect.

Recreational marijuana is illegal in Austria. Anyone who culti- vates, manufactures, trades with, imports, exports, sells, gives away, otherwise puts into circulation, acquires or in any other way procures or possesses non-medical cannabis, commits a criminal offense under the narcotic Drugs Act. While severe cases (e.g., trafficking by leading gang members) can be punished with up to 20 years in prison, simple possession is generally subject to lower penalties (e.g., up to one year or six months for personal use).

Though ingredients of the hemp plant not containing THC in a pure form above 0.3% are not classified as a narcotic drug and may be consumed without infringing the law. See section 3 below.

The following section is therefore not applicable for the Austrian jurisdiction.

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Only cannabis or marijuana (as defined in Annex I of the Administrative Act on Narcotic Drugs) is considered illicit, with the exception of the use for medical purposes. Hence it is commonly hold that other parts of the hemp plant are not illegal. According to Annex I of the Administrative Act on Narcotic Drugs and the statutory acts referred therein also flowers and seed heads considered legal if the THC concentration does not exceed a certain threshold.

The cultivation of hemp (including the flower and the seed head) requires no license as long as the hemp strain is qualified in Section 65 of the Federal Act on Seeds (Saatgutgesetz 1997, BGBl. I Nr. 72/1997) or in Article 17 of the EU Direc- tive 2002/53/EG, and the THC concentration does not exceed 0.3%. The licensing of hemp strains not listed in the before mentioned provisions is possible but require at least two years due to cultivation tests over several growing seasons.

If the cultivation involves cannabis plants with a THC concentration exceeding 0.3% for the purpose of obtaining narcotic drugs for the production of pharmaceuticals, it is exclusively permitted to the Austrian Agency for Health and Food Safety (AGES). Scientific institutions may cultivate such plants for scientific purposes if they hold a confirmation from their supervisory authority."It has to be noted, that government funding of agricultural areas is only granted if the hemp is qualified in accordance with the Regulation (EU) Nr. 1307/2013.

A broad range of different regulations may apply depending on the kind of the manufactured products. Common and at the same time extensively regulated is the manufacturing of food- and cosmetic-products. The manufacturing of food per se does not require a license under trade law (except i.e. baker, confectioner or butcher). The use of certain ingredients such as ingredients from the hemp plant rely on the authorization of the product and not on the processing of the product.

No specific rules or licensing requirements apply for the dis- tribution of products containing hemp to other resellers. However, as mentioned before, a wide range of product-specific rules applies: Distributors of cosmetics must verify labeling compliance (Art. 6 EU Nr. 1223/2009), and distributors of pharmaceuticals require a specific wholesale license under the Medicines Act (§ 63 AMG).

The production of food containing hemp ingredients may conflict with the Regulation (EU) 2015/2283 (“Novell Food Regulation”). Food is qualified as “Novell Food” if it has not been consumed in the EU in a qualified amount before 15th May 1997 and if it falls within one of the 10 categories of the Regulation. Novell Foods require an admission before distribution to consumers.

When marketing products containing hemp based on disease-related statements the product may be classified as a presentation medicinal product (Präsentation- sarzneimittel) although it contains no ingredients adhering to a physiological, pharmacological or immunological effect, and thus require licensing for selling pharmaceutical products (see already Section 1.3 and 1.4.).

In respect to potency please refer to Section 3.1 above.

There may apply specific rules concerning the combination with other products depending on the regulation of the final product. In respect to food products please refer to Section 3.2 and 3.4 above.

No, the subject matter is solely regulated by the federal authorities.

The legalization of hemp had the most impact on the following branches:

• Non-woven fabric & Building materials: Enabled by the exemption of certified hemp varieties (listed in the EU Common Catalogue pursuant to Directive 2002/53/EC) with less than 0.3% THC from the definition of narcotic drugs (Annex I, Narcotic Drugs Decree), allowing the legal cultivation of fiber hemp.
• Food: Heavily impacted by the Novel Food Regulation (EU) 2015/2283, which requires authorization for extensive hemp extracts (like CBD) while permitting traditional hemp seeds.
• Cosmetics: Regulated by EU Regulation 1223/2009, which bans narcotics but allows ingredients derived from seeds/leaves or synthetic origin, provided a safety assessment confirms compliance.

The production, processing, conversion, acquisition and possession of narcotic drugs is, according to Section 2 par. 1 Administrative Act on Narcotic Drugs in principle only permitted in accordance with a license granted by the Federal Minister of Labor, Social Affairs, Health and Consumer Protection.

As long as cannabis ingredients or hemp ingredients as CBD are derived from a strain as qualified in Section 65 of the Federal Act on Seeds or in Article 17 of the EU Directive 2002/53/EG and the THC concentration does not exceed 0,3%, they do not qualify as narcotic drugs.

Please see in this respect Section 1.1 and 3.1 above.

As long as cannabis ingredients or hemp ingredients as CBD are derived from a strain as qualified in Section 65 of the Federal Act on Seeds and the THC concentration does not exceed 0.3%, they do not qualify as narcotic drugs (Annex I Narcotic Drugs Decree). Therefore, no narcotics license is required for the processing of such hemp.

However, depending on the final product category, specific manufacturing permits apply:

• Pharmaceuticals: The manufacturing of medicinal products requires a manufacturing authorization from the Federal Office for Safety in Health (BASG) pursuant to Section 63 of the Medicines Act (AMG) and adherence to Good Manufacturing Practice (GMP).
• Cosmetics: Manufacture must comply with Good Manufacturing Practice (Article 8 EU Regulation 1223/2009) and requires a safety assessment, though no specific facility license is needed.

As with manufacturing, products containing hemp ingredients derived from certified strains with <0.3% THC do not qualify as narcotic drugs (Annex I Narcotic Drugs Decree), so no narcotics license is required for their distribution.

However, specific licensing requirements for distribution apply depending on the product category:

• Pharmaceuticals: The distribution to other resellers requires a Wholesale Authorization (Großhandelsbewilligung) from the Federal Office for Safety in Health (BASG) pursuant to Section 63 of the Medicines Act (AMG).
• Cosmetics: No specific license is required for distributors. However, pursuant to Article 6 of EU Regulation 1223/2009, distributors must verify that the product bears the correct labeling, language information, and expiration date before making it available on the market. They do not need to perform safety assessments or adhere to GMP themselves, unless they modify the product or market it under their own name.

Depending on the characteristics of the products distributed to consumers a wide range of licensing requirements may apply under trade law and other branch related provisions. As already pointed out in Section 1 the distribution of pharmaceutical products to consumers requires more than one license. The same also applies for food products or tobacco products.

CBD containing extracts marketed as such or in foods - mainly as food supplements (e.g. CBD oil) - are generally considered novel foods under Novel Food Regulation (EU) 2015/2283. Novel foods are those that have not been used for human consumption to any significant degree in the European Union prior to May 15, 1997 ("history of safe consumption") and fall into at least one of the categories listed in Article 3(2)(a) of the above-mentioned Regulation. Only approved novel foods included in the Union list may be placed on the market as such or used in foods in accordance with the conditions and labeling requirements laid down in the list. At present, there is no such authorization for CBD. Thus, placing on the market is not permitted.

Regarding the use of cannabis and extracts thereof in cosmetic products, reference should be made to Article 14 (1) (a) in conjunction with Annex 2 No. 306 of Regulation (EC) No. 1223/2009. In this list of substances prohibited in cosmetic products, natural and synthetic narcotic drugs are mentioned. In this context any substance listed in Tables I and II of the UN Single Convention on Narcotic Drugs (ESK 1961) is considered a narcotic drug, thus including cannabis and extracts made from it. It is therefore not permissible to distribute cosmetic products containing CBD.

When marketing products containing CBD based on disease-related statements of the product the product may be classified as a presentation medicinal product although it contains no ingredients adhering to a physiological, pharmacological or immunological effect and thus require licensing for selling pharmaceutical products (for licensing for distribution of pharmaceutical products see already Section 1.3 and 1.4.).

Currently, tobacco and related products containing CBD or hemp are increasingly being marketed in the form of "hemp cigarettes", e-cigarettes containing CBD liquids, etc.

The distribution of tobacco products and e-cigarettes containing nicotine or liquids with vitamins or other additives that give the impression that these products have a health benefit or pose lower health risks are expressly prohibited pursuant to Section 8b and Section 10b of the Act on Tobacco and Nonsmoker Protection (Tabak- und Nichtraucherinnen- bzw. Nichtraucherschutzgesetz (TNRSG), BGBl. Nr. 431/1995). Since health benefits such as antiphlogistic or anxiolytic effects are generally attributed to CBD the distribution of tobacco products and e-cigarettes containing CBD might be considered illicit and carry a fine.

Please see Section 4.4 above.

Regarding CBD, there are no specific requirements on potency or formulation. However, all CBD products must comply with the threshold for THC concentration as described above.

For the combination with other products see Section 4.4.

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During 2018, there was a real boom in CBD products. In particular, food and dietary supplements with CBD were very popular.

The hype has cooled down since a writ was issued by the Federal Minister of Labour, Social Affairs, Health and Consumer Protection, stating that food, cosmetics and tobacco products containing CBD are under certain circumstances considered illicit.

Currently, the industry faces strict regulatory scrutiny at the EU level:

• Food: CBD extracts remain classified as Novel Foods under Regulation (EU) 2015/2283 and generally lack the necessary market authorization, making their distribution in food supplements largely non-compliant.
• Cosmetics: While formerly a gray area, the safety of CBD in cosmetics is now under active investigation. The Scientific Committee on Consumer Safety (SCCS) has issued a preliminary opinion investigating potential genotoxicity (DNA damage) caused by CBD.

The competent agencies are the Austrian Agency for Health and Food Safety GmbH (AGES), the Ministry of Labour, Social Affairs, Health and Consumer Protection and Federal Office for Safety in Health (BASG).

The relevant laws are:

• Administrative Act on Narcotic Drugs; and
• The Narcotic Drugs Act.

There are no special financial incentives to spur the cannabis industry development in Austria from the government.

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A legalization of recreational marijuana might be accomplished by legislative acts. The political intent of the legislative body does not provide for loosening of restrictions in this respect in the near future.

The loosening of the restrictions on the use of CBD as a food supplement or in cosmetics relies to a great extent on the EU legislative body. The development on this subject has to be monitored carefully.

Based on the recent regulatory changes in the EU and Austria, the legal landscape for cannabis-related products has shifted from general prohibitions toward specific safety thresholds and stricter enforcement. Most notably, the EU Scientific Committee on Consumer Safety (SCCS) issued a pivotal opinion in October 2025, establishing that Cannabidiol (CBD) in cosmetics is considered safe only up to a concentration of 0.19% in leave-on products, provided that trace THC does not exceed 0.00025% (2.5 ppm).

Based on the SCCS Scientific Opinion (SCCS/1685/25) adopted on 30 October 2025, a significant regulatory shift has occurred regarding the safety assessment of Cannabidiol (CBD) in cosmetics. The Scientific Committee on Consumer Safety (SCCS) concluded that CBD is safe for use in dermal leave-on and oral cosmetic products up to a maximum concentration of 0.19%, provided that the content of Delta-9-THC as an impurity does not exceed 0.00025% (2.5 ppm). This opinion clarifies that while CBD itself generally does not pose genotoxicity or carcinogenicity risks, the presence of trace cannabinoids like THC must be strictly controlled to ensure consumer safety. This scientific advice is expected to guide future amendments to Regulation (EC) No 1223/2009, effectively replacing the previous legal uncertainty with precise quantitative limits for the industry.

Although the use of hemp beyond the classical industrial utilization is not forbidden in Austria, the marketing and distribution to the consumer as a food product or recreational product is at the moment subject to restrictions and infringement might carry fines or in the worst case a prison sentence. Therefore, a sound analysis of the intended commercial activity in the context of the applicable laws is essential before engaging in any related business activities.