Balancial has Been Authorised by the Danish Medicines Agency

April 22, 2021

Balancial has been authorised by the Danish medicines Agency to conduct activities with euphoriant substances and manufacture cannabis intermediate products. This important milestone ensures, that Balancial's imported products, contribute with high level of quality and patient safety.

Balancial has a high standard of quality of medical products and is equipped to respond appropriately if any errors occur during the process. Doctors and patients can now be ensured that Medicinal Cannabis products by Balancial can only be used for medical reasons and its high level of quality is assured for patient benefit. These permits guarantee, high reliability of prescriptions by doctors and reassurance for patient safety.

A message from Bo Tandrup, CEO of Balancial
"Medicinal cannabis is a controversial subject, and it took me some careful consideration before I accepted the position as CEO in Balancial. As a pharmacist I am just as cautious as any industry professional when it comes to putting my name behind something and we all know that medicinal cannabis products are not authorised medicines. They still miss large clinical trials to provide solid knowledge of effects and side effects.

However, a few important facts motivated me to join Balancial and start working with medicinal cannabis products.

Firstly, although not exhaustive, we do have some clinical data to support the use of medicinal cannabis. The Danish Medicines Agency has prepared guidelines for doctors based on extensive literature searches, assessments of the review of scientific evidence from the National Academy of Sciences (USA, 2017), evaluation of cannabis schemes in other countries and evaluation of the data leading to previous licensing of cannabis-containing medicines in Europe and the USA.

Secondly, the treatment with medicinal cannabis is something you try only if the patient has been treated with relevant authorised medicine with an insufficient result. In other words, it is not a substitute, but if the patient has not benefitted from authorised medicines, we can try medicinal cannabis.

Finally, it is my responsibility, as a pharmacist, to assist doctors and make any medicinal product available as long as such product is admitted or approved by the Danish Medicines Agency, including medicinal cannabis products.

At Balancial our job is to confer with doctors from various clinical fields, listen to their recommendations and select products to be made available for doctors to prescribe in Denmark. We are pharmaceutical industry professionals. We do not grow hemp and we do not develop products. We focus entirely on assuring that the products we select for the Danish market conforms with any and all regulatory requirements.

Doctors should be sceptical but remember that the intention with the Danish pilot programme is to provide a better basis to assess the use of medicinal cannabis."

Guidelines for doctors: https://laegemiddelstyrelsen.dk/en/special/medicinal-cannabis/healthcare-professionals/guidelines-for-doctors/

Balancial’s products should be considered only for the following indications that are supported by some evidence:

• Painful spasms caused by multiple sclerosis
• Painful spasms caused by spinal cord damage
• Nausea after chemotherapy
• Neuropathic pain, i.e. pain due to a disease of the brain, spinal cord or nerves

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