Cannabis as prescription

Definition
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With the Act on the Amendment of Narcotics Law and Other Regulations, which came into force on March 10, 2017, the legislator expanded the options for prescribing cannabis medicines.

Since April 1, 2024, key parts of the Act on the Controlled Use of Cannabis and the Amendment of Other Regulations (Cannabis Act - CanG) have come into force. Possession of cannabis up to 25 grams of dried cannabis in public spaces and 50 grams in private spaces is exempt from punishment for adults. Consumption is prohibited in pedestrian zones from 7 a.m. to 8 p.m.

Cannabis is excluded from the scope of the Narcotics Act. Cannabis for medical purposes and cannabis for medical-scientific purposes will in future be regulated by the MedCanG, the competent authority being the Federal Institute for Drugs and Medical Devices (BfArM). The sale of medicinal cannabis by doctors and in pharmacies is subject to supervision by the respective state authorities.

For questions and answers on cannabis as medicine, see also information from the Federal Ministry of Health and information from the health insurance funds.

General information
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What must be considered before prescribing a cannabis medicine for the first time? When prescribing the approved finished medicinal products ^Sativex® or ^Canemes® outside the approved indications or cannabis flowers, cannabis extracts not approved as finished medicinal products or dronabinol at the expense of the SHI, the patient must submit an application for approval of cost coverage to the responsible health insurance fund before the first prescription. Reference is made to Section 31 (6) of the Fifth Book of the German Social Code. In each of the aforementioned cases, the patient must be informed that a concomitant survey will be carried out . For information on prescribing at the expense of the statutory health insurance funds, see information from the KBV

How must cannabis medicines be prescribed? Since 01.04.2024, cannabis medicines no longer have to be prescribed on a narcotic prescription, but can be prescribed on a normal prescription (e-prescription, sample 16). Important: the only exception is the synthetic cannabinoid nabilone(trade name ^Canemes®), which is still subject to the BtMG and may only be dispensed on a BtMG prescription! (Narcotics in Annex III to § 1 paragraph 1 of the Narcotics Act).

Who may prescribe cannabis medicines? In principle, all persons who are authorized to practice medicine are entitled to prescribe narcotics (nabilone) on a narcotics prescription. Dentists and veterinarians, however, are not authorized to prescribe cannabis. The generally applicable regulations for prescribing narcotics must be observed for every prescription of Nabilone.

All other cannabis medicines can be prescribed by all doctors (general practitioners and specialists) on a normal prescription (e-prescription, sample 16) in compliance with the statutory regulations and the requirements for reimbursement by the statutory health insurance funds.

Will there be different types of cannabis products? There will be different varieties of cannabis flowers and extracts. The respective varieties will be clearly identifiable by their name and defined by their THC and CBD content. The content of ingredients will vary.

How can I ensure safety in therapy? As with other natural products, the content of the ingredients in the individual products varies. However, the range of fluctuation is limited by the definition in the monograph on cannabis. Since, according to the scientific information available to date, cannabis has a relatively high therapeutic range, fluctuations in the active ingredient content in the acceptance range should only have a minor effect - if any - on the efficacy and safety of therapy with these products.

Where can I get information about the available varieties? The BfArM assumes that the relevant suppliers will make the available varieties known to healthcare professionals.

Where can I get information on dosage? With regard to the finished medicinal products ^Sativex® (thick extracts of cannabis), ^Marinol® (active ingredient: dronabinol) and ^Canemes®(active ingredient: nabilone), please refer to the respective product information. Scientific information on the dosage of unauthorized cannabis medicinal products (especially flowers) is only available to a very limited extent. Further information can be found on the website of the Canadian authority Health Canada under the title "Information for Health Care Professionals". The BfArM assumes no responsibility for the completeness and accuracy of this information.

What must be on the prescription for narcotics (BtM prescription)? Can I prescribe cannabis medicines even if the health insurance company does not agree to cover the costs? The current legal framework allows the prescription of cannabis medicines in all justified cases. Cost coverage by health insurance companies is not a mandatory condition for prescribing.

Since, with the exception of Sativex®, no finished cannabis-based medicinal products are currently available, extracts and flowers are dispensed as prescription medicines in pharmacies. The prescription of cannabis medicinal products is also permitted in the case of patient care via narcotic request forms.