FAQs

All Bedrocan cannabis products that are produced in the Netherlands are gamma-irradiated by an external irradiation firm. The products that are being cultivated in the Danish facility have undertaken an electron beam sterilization, also executed by an external firm. Both methods sterilises the cannabis and give it a longer shelf life. In the Netherlands the irradiation is done on behalf of the Office of Medicinal Cannabis, in Denmark on behalf of Bedrocan. Cannabis naturally contains a number of micro-organisms that can cause dangerous infections in people with a poor state of health. Irradiation with gamma rays or e-beams destroy these micro-organisms, such as bacteria and fungi. Irradiation does not adversely affect the quality of the product or people’s health. Nor is the product made radioactive, as is sometimes thought.

Does irradiation make cannabis carcinogenic?

Irradiating does not make cannabis carcinogenic. Carcinogens are only caused in very small quantities when food containing a lot of fat, such as meat and eggs, is irradiated. Cannabis does not contain any fat, and this process therefore does not occur.

How is Bedrocan's cannabis irradiated?

The irradiation is done in a type of bunker with walls of 2.5 to 3 meters thick concrete, where the products are irradiated. Sterilisation, as the process is euphemistically called, is done 24 hours a day, seven days a week, and is fully automated. Read more >>    

Cannabis can have a relaxing effect on the body and mind. It can also be used as a pain killer, as an anti-inflammatory, and to prevent weight loss, nausea and vomiting. In some cases cannabis promotes sleep and appetite. Cannabis treatment is mainly for pain associated with the nervous system, for example pain caused by damaged nerves bundles, phantom pain, facial neuralgia and chronic pain that remains following recovery from shingles.

Chronic pain

To date, the therapeutic benefit of medicinal cannabis has only been seen in neuropathic pain studies – the suffering originating from injury or disease that affects the sensory nerves. By comparison, studies measuring the effects on acute pain (e.g. postoperative pain) often show no beneficial effects. Most likely, this difference is related to the role endocannabinoids play in both types of pain. However, the mechanism behind this difference is not yet fully understood. Chronic neuropathic pain is common, difficult to treat, and has limited treatment options. Consequently, even the modest effects of cannabinoids may be important for patients. Patient preference studies show the side effects from cannabinoids are better tolerated than strong opioid medications. Indeed, cannabis has often been studied in combination with other medicines, including for example morphine. It has been found that cannabinoids and opioids work together with a strong combined effect.

Scientific evidence

There is also sufficient scientific evidence to demonstrate that cannabis is effective for the treatment of:

• Muscle cramps, pain and convulsions caused by MS and spinal damage
• Nausea, diminished appetite, emaciation and weakness caused by cancer and AIDS
• Nausea and vomiting caused by chemotherapy or radiotherapy to treat cancer, hepatitis C and HIV infections and AIDS
• Gilles de la Tourette syndrome
• Therapy-resistant glaucoma

Also, more and more information and positive feedback is being received from patients and doctors concerning the efficacy of cannabis for other disorders. However, this is has not yet been sufficiently scientifically demonstrated. Examples include Crohn's disease, colitis ulcerosa, epilepsy, pruritus (itching), migraine, rheumatism, rheumatoid arthritis, ADHD and brain trauma. See also our medical conditions page.

Patient orders

As a patient, you cannot order medicinal cannabis products directly from Bedrocan. Bedrocan’s products are available exclusively on prescription. Your GP or treating specialist can prescribe Bedrocan’s medicinal cannabis. Provided that your government issues medicinal cannabis in your country, you can take the prescription to your own pharmacy. You can also collect Bedrocan products in the Netherlands with a valid European doctor’s prescription. You can take this prescription to any Dutch pharmacy. It is however advisable to check whether the pharmacy stocks medicinal cannabis.

Cannabis oil

Medicinal cannabis oil made of cannabis produced by Bedrocan is exclusively available on prescription from a number of Dutch pharmacies. Please check our contact page for the latest list. Bear in mind that you can only take medicinal cannabis back to your own country with an import licence. You should therefore always start by contacting the authorities in your own country. The Dutch Office of Medicinal Cannabis issues the export licence once the import licence has been issued. Please note:According to Dutch law, medicinal cannabis oil may not be exported from the Netherlands.

Business orders

Bedrocan produces medicinal cannabis as an active pharmaceutical ingredient (API) or a raw material. Bedrocan does not produce cannabis oil. Orders for cannabis can be placed directly with Bedrocan. The Dutch government agency Office of Medicinal Cannabis (OMC) is responsible for issueing the export license. Follow the procedure given on the OMC website. For advice please contact us.

Many different types of pesticides can be used in cannabis cultivation, but none are approved for use in cannabis. They are very harmful to patients’ health. Therefore, Bedrocan does not use any pesticides. During the cultivation process Bedrocan only uses biological crop protectors to repel harmful insects. In addition, Bedrocan only grows cannabis indoors, so that pesticides used by farmers outdoors cannot cause contamination.

The absence/presence of microorganisms

During cultivation the cannabis plant can host harmful microorganisms like fungi and bacteria which can end up in the finished product. Strict hygiene measures prevent contamination with germs. Still decontamination treatment by gamma irradiation is required to eliminate microorganisms such as Staphylococcus Aureus and Escherichia Coli. The process does not affect the quality of the finished product.

The absence/presence of heavy metals

The cannabis plant can quickly take up heavy metals from soil – termed heavy metal bio-accumulation. Every batch is checked for the presence of harmful heavy metals such as arsenic, cadmium, lead and mercury.

Independent tests

Bedrocan's cannabis products are independently tested by a specialised laboratory. The test the laboratory undertakes include the absence/presence of pesticides, heavy metals and microorganisms. This test ensures the finished product does not contain any contamination. The test results of medicinal cannabis produced by Bedrocan in the Netherlands can be checked in the release certificates. More information about our method.  

When using higher doses of medicinal cannabis, the user may become ‘high’. People cannot get high from passive smoking, as is often thought. The main component of cannabis, THC, is responsible for the euphoric effect. With large doses of THC, uncontrolled fits of laughter, a feeling of joy and mild euphoria, or a distorted reality (in colors and sounds) can occur. Some patients may experience mild feelings of anxiety. This is also called overdose. Especially for people who have no experience with cannabis, the feeling of getting high is often unpleasant or even frightening. During treatment with medicinal cannabis, the patient is supervised by a doctor. This can adjust the dosage so that the chance of overdose, and therefore getting high, is very small. In general, patients report no or few side effects from medicinal cannabis. The side effects that can occur include: dry mouth, increased appetite, higher heart rate, dizziness and being easily distracted.

Bedrocan has several production locations from where Bedrocan cannabis products can be shipped. Cannabis products are only supplied to companies with a valid import permit. No cannabis products are supplied to private individuals.

Import from the Netherlands

The Dutch Office for Medical Cannabis (OMC) exports our medicinal cannabis products produced in the Netherlands to various countries on request. Please contact our commercial team if you need any help. For some countries separate rules apply, this is the case for the Canadian market where import and export of medicinal cannabis is restricted.

Import from Denmark

Medicinal cannabis products produced in the Danish facility are shipped directly by Bedrocan. Please contact our commercial team for more information on the procedure. Please note: Medicinal cannabis oil is not exported from the Netherlands.

There are several ways to use medicinal cannabis. A safe and widely used method is vaporization. Patients often use a vaporizer for this. A vaporizer does not burn the plant material, but heats it to a very high temperature. The vapor contains the active substances, including THC and CBD. These enter the bloodstream via the lungs.

Cannabis oil

Another widely used method is taking drops of cannabis oil. Oil is applied under the tongue. The mucous membranes absorb a large part of the active substances. Smoking cannabis, on the other hand, is not recommended. When smoking, the cannabis is burned, which releases high concentrations of toxic substances. These then enter the bloodstream via the lungs.

Bedrocan® medicinal cannabis has been available in Australia since June 2017.

Pharmacies

Australian pharmacies may order Bedrocan® cannabis online. The online portal is only accessible to registered pharmacies with a pharmacy account with the distribution agent Novachem. If you wish to apply for an account, please visit Novachem’s website. You can also contact Novachem through mail or phone:

• email: bedrocan@novachem.com.au
• phone: 1800 668 224 or +61 3 84151255

Patients in Australia

If you are an Australian patient, you cannot order medicinal cannabis directly from us. In Australia medicinal cannabis is available under the Special Access Scheme (SAS), on prescription from your prescribing doctor. The SAS allows certain health practitioners to prescribe medical cannabis products and medical devices that are not included in the Australian Register of Therapeutic Goods to a single patient in some circumstances.

Pharmaceutical companies

Bedrocan produces multiple chemovars of medicinal cannabis as an active pharmaceutical ingredient (API) and raw material. Each of these chemovars has a different THC:CBD ratio. Companies that wish to use our cannabis for product development can contact us directly. This includes placebo cannabis products. Australian industry may order API by contacting our distributor Novachem:

• email: bedrocan@novachem.com.au
• phone: 1800 668 224 or +61 3 84151255

In Australia medicinal cannabis is not a registered medicine and is not listed on the Australian Register of Therapeutic Good (ARTG). Products not included in the ARTG are referred to as unapproved therapeutic goods. Bedrocan® falls into this category of unapproved therapeutic goods.

Prescribe Bedrocan®

Australian doctors who wish to prescribe Bedrocan® need permission from the Therapeutic Goods Administration (TGA) and the health department of the relevant state or territory. Contact details for the health departments of each Australian state and territory can be found on the Department of Health website. There are two ways to prescribe Bedrocan®:

• Special Access Scheme (SAS) - an individual patient on a case-by-case basis
• Authorised Prescriber Scheme - multiple patients with the same condition

Special Access Scheme applications can be made online, with approval usually being given within 24–48 hours. More information about these two routes can be found on the Australian Authority's website. A doctor may also refer a patient to another doctor or clinic that already has experience prescribing cannabis. NOTE: You must be registered or licensed by the Australian Health Practitioner Regulation Agency (AHPRA) to get access to the online system.

More information

This website provides healthcare professionals with free, evidence-based information about cannabis-based medicines, including administration, dosing and potential drug interactions.

Bedrocan's medicinal cannabis products are available to patients in more and more countries. Our site contains a list of countries where Bedrocan can be obtained with a doctor's prescription.

Note to patients

You cannot order medicinal cannabis at Bedrocan. Bedrocan’s products are available exclusively on prescription. Your GP or treating specialist can prescribe Bedrocan’s medicinal cannabis. Provided that your government issues medicinal cannabis in your country, you can take the prescription to your own pharmacy.

Current cannabis products from Bedrocan can be administered by inhalation, through a high-quality vaporizer offered by Storz & Bickel or Syqe Medical. Typically, the administration method will depend on the type of treatment medicinal cannabis is used for. Typically, inhalation of cannabis material through a vaporizer offers a relatively quick effect, which is particularly beneficial for patients suffering from chronic pain, as they require an immediate relief of pain. For other treatments an oral or oromucosal route of administration may be more suitable, as it offers a longer effect. Bedrocan’s education material like the Clinical primer, and Prescribers Update will provide healthcare professionals with additional insight into the matter and hopefully facilitate the right decision.

Following each harvest the cannabis is tested by an independent laboratory for the presence of undesirable substances such as heavy metals, pesticides and contamination with other pathogens. The products are also tested for substances such as THC and CBD. Bedrocan’s products always have the same composition and therefore always contain the same quantity of active substances. This is government controlled. Batches of medicinal cannabis are not released until they have been fully approved.

Good manufacturing practice

The quality of medicinal cannabis from other  sources than Bedrocan can vary greatly. This poses risks and uncertainties to patients and their prescribers. All cannabis products from Bedrocan are of pharmaceutical-quality and meet good manufacturing practice (GMP) standards. GMP is the highest standard of medicine manufacture. Our personnel, premises and materials meet these standards consistently. Each part of our production and testing process is clearly documented. These processes provide patients and prescribers with the safest and most reliable products.

Also read

• Consistency through standardisation
• Our quality standards

 

Medicinal cannabis is usually prescribed in low doses, which means that the chance of developing a cannabis addiction is not to be expected. In addition, medicinal cannabis is prescribed by a doctor or specialist who is closely involved in the patient's health problems. When cannabis is used in a high(er) dose, there is a chance of addiction. If a patient suddenly stops, withdrawal symptoms such as restlessness, irritability, insomnia and nausea can occur.

Smoking cannabis, for therapeutic reasons or for pleasure, is harmful to the one's health and is therefore not recommended. It is unhealthy because smoking releases harmful substances into the lungs and bloodstream. In addition, it is unpleasant for the patient's environment, due to the strong smell and smoke.

Smoking vs medical vaporizers

There are various other ways to use cannabis. Such as vaporizing cannabis by means of a (medical) vaporizer. They offer patients an effective, safe and user-friendly method of administration. The inhaled vapor is, just like with smoking, quickly absorbed by the lungs and the effect is therefore immediate and allows for rapid relief of symptoms. The amount of cannabinoids delivered in the vapor depends on the depth of inhalation and the duration of the breath-hold. Although inhalation results in higher levels of cannabinoids in the blood, the effects are shorter in duration compared to oral administration.

In the Netherlands, the prices for prescription CBD oil (based on the raw material Bedrolite®) vary between 50 and 150 euros for a bottle of 10ml. The price depends on the concentration of CBD (cannabidiol).  There are a number of Dutch pharmacies (e.g. Transvaal, Clinical Cannabis Care) in the Netherlands that prepare CBD oil according to pharmaceutical guidelines. This oil meets the highest requirements, has a constant composition and is guaranteed to contain no THC. Please check our contact page for Dutch pharmacy contact details. These pharmacies also have more information on treatment, indications and the composition of medicinal cannabis. Medicinal CBD oil is only available on prescription.

In the Netherlands, the prices for prescription THC oils (or medicinal cannabis oil) vary between 25 and 178 euros for a 10 ml bottle. The price depends on the concentration of THC, which can vary between 0.5 and 10 percent. Most prescription THC oils also contain CBD (cannabidiol). That percentage can also differ per oil. There are several pharmacies in the Netherlands that compound THC oil according to pharmaceutical guidelines. This oil meets the highest requirements, has a constant composition and is guaranteed to contain no contaminants such as pesticides, fungi or heavy metals. This oil is specially prepared for patients and is only available with a doctor's prescription. There are various routes of administration for medicinal cannabis. Cannabis oil is the most commonly prescribed, followed by vaporization and tea as popular modes of administration. On our Dutch contact page you will find the contact details of the Dutch pharmacies (e.g. Transvaal, Clinical Cannabis Care) that can supply medicinal cannabis oil. Also read: What does prescription CBD oil from a Dutch pharmacy cost?

Medicinal cannabis, or medical marijuana, is cannabis that is dispensed exclusively by pharmacies and is intended for therapeutic use. It is prescribed by a trained medical professional, for a known medical condition or a set of conditions where it has proven to be an effective treatment.

Cannabis sativa L.

Cannabis is a member of the Cannabaceae family and contains a number of active elements such as phytocannabinoids. They occur naturally in cannabis. The most studied phytocannabinoids are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is the most well-known cannabinoid. THC is responsible for many of the medicinal effects of cannabis. These may include, among others, reduction of nausea, vomiting, pain and muscle spasms, and improvement of sleep and appetite. CBD is another major cannabinoid. It has medicinal effects, but does not induce a psychotropic state (i.e. its use does not result in feelings of intoxication). CBD may be effective in conditions such as epilepsy, posttraumatic stress disorder (PTSD), and anxiety disorder.

Bedrocan's products

Bedrocan's medicinal cannabis contains both THC and CBD. The cannabis is of pharmaceutical quality and meets the highest standards. As with ordinary medicines, the composition of the active substances in our cannabis is always the same. Also, Bedrocan's  cannabis products are guaranteed to be free of pesticides, heavy metals, bacteria and fungi. Each batch is tested for this by an independent laboratory.

Medicinal cannabis or medical marijuana?

Actually, we are not a fan of the term medical marijuana, or words like weed, grass, pot or dope. At Bedrocan we prefer to use the term medicinal cannabis. Why that is, you can read in the article Medicinal cannabis or medical marijuana?

A primer to medicinal cannabis

We have also written an introductory text to the therapeutic use of cannabis which you can download for free from the downloads page. It is meant to give health professionals, regulators and patients valuable insights on how this plant can be used in the chain of therapeutic options.

Medicinal cannabis oil is oil made of pharmaceutical quality standardised medicinal cannabis. Medicinal cannabis oil is made using the products Bedrocan®, Bediol®, Bedrobinol®, Bedrolite® and Bedica®. This oil may contain THC, depending on which materials have been used. These oils are produced in a pharmaceutical setting. The active substances are listed on the packaging. This is the only controlled cannabis oil.

Medicinal CBD oil contains cannabidiol as active ingredient, one major cannabinoid from the cannabis plant. CBD is a psychoactive substance, but does not have intoxicating effects, even at higher doses. Patients should preferably consult a doctor if they want to start using a product containing CBD. CBD is a cannabinoid that acts on specific receptors in humans and interacts with other medication. Furthermore, patients should obtain CBD oil, e.g. Bedrolite® oil, for oral or oromucosal dosing from the pharmacy. Oils compounded by a pharmacy meet the highest pharmaceutical quality requirements. That cannot be said about the oil that can be bought online or at the drugstore. In recent years, a large, unregulated market for CBD oils and extracts have emerged. These products are typically derived from fibre-type cannabis strains, the industrial hemp plant, which contain large concentrations of CBD, but negligible THC. Most of the times it does not contain the amount of CBD that is stated on the label. The origin of the raw materials is often unclear. It is also possible that the oil is contaminated with heavy metals or pesticides. The production of this unregulated CBD oil is not controlled by the government in most countries. These oils are sold as a nutritional supplement. Also read: Label accuracy of unregulated cannabidiol (CBD) products: measured concentration vs. label claim To learn more about the effect of CBD, download a free copy of  A clinical primer.    

THCA (tetrahydrocannabinolic acid) is a phytocannabinoid acid, an inactive form found in a fresh cannabis plant. THCA turns into THC (delta-9-tetrahydrocannabinol) when sufficient heat is applied. Therefore, contrary to popular belief THC is not actually present in fresh cannabis plants. Heating THCA to temperatures above 100ºC causes decarboxylation (releasing CO2), converting the acid into their bioactive form THC. THC is psychoactive, euphorigenic, and has intoxicating effects at high doses. In the body, THC is converted to a potent psychoactive metabolite, 11-hydroxy-THC (11-OH- THC). Current prescribing indicates that cannabis-based medicines containing THC or THC:CBD are mainly used in the context of pain, oncology, or palliative care settings. Clinical benefits are observed in conditions such as pain, nausea, and vomiting.

Cannabidiolic acid

Another abundant acid form is cannabidiolic acid (CBDA). The active form is CBD (cannabidiol). CBD is psychoactive but does not have intoxicating effects. Source: Clinical primer - A guide to the rational use of cannabis-based medicines  

Bedrocan has published an introductory text to the therapeutic use of cannabis. This brochure gives health care professionals, regulators and patients insights into the medical and scientific aspects. Go to our download page to get a free copy.  

There is currently one cannabis product available in Australia. It carries the same name as the company: Bedrocan®. Bedrocan® is the brand name of the cultivar Cannabis sativa L. ‘Afina’. It was the first cultivar produced by us, with the first seed grown in the early 1990s. The product is the most used in clinical research and is commonly prescribed for the treatment of pain. Bedrocan® is currently produced in our facilities in the Netherlands and Denmark. There are currently two product forms available.

Bedrocan® flos

Content 22% THC | < 1% CBD

Cannabis flos is the whole, dried inflorescence of the cannabis plant. Bedrocan® cannabis flos is fully standardised, with a consistent cannabinoid and terpene composition. The product is free of pesticides and heavy metals and is irradiated for microbiological purity.

Bedrocan® cut flos

Content 21% THC | < 1% CBD

Cut flos has a uniform distribution of cannabinoids, terpenes, flavonoids, and other plant compounds throughout the product – batch-to-batch, dose-to-dose. This results in an even more consistent content compared to flos. This form is also free of pesticides and heavy metals and irradiated for microbiological purity. Because cut flos is already ground, patients no longer need to grind the cannabis themselves. This is not only practical for those who have difficulty with this procedure but also avoids contamination during dose preparation.

Bedrocan®-derived extracts

Partner companies produce extracts made from Bedrocan®  raw material and these products should be also available in Australia soon.

Other products from Bedrocan

Bedrocan produces multiple cannabis varieties for product development and therapeutic use. Each cannabis product is standardised according to pharmaceutical standards with a defined active ingredient composition. Check the products page to learn more.

More information for Australian healthcare practitioners

If you are an Australian healthcare practitioner and wish to find out more about our Bedrocan® product, please contact our local distributor Novachem:

• email: bedrocan@novachem.com.au
• phone: 1800 668 224 or +61 3 84151255

You can also go to our HCP section on our website.