The Royal Decree of 11 June 2015 prohibits the
delivery of preparations containing tetrahydrocannabinolen (THC).
Because cannabidiol (CBD) may be contaminated
with a trace amount of THC, until recently CBD-based preparations were
completely out of the question.
The Federal Agency for Medicines and Health
Products (FAMHP) now interprets, by means of its circular of 16 July 2019, the Royal Decree of 11 June 2015 in the sense that pharmaceutical preparations
based on CBD are permitted.
In its circular, the FAMHP provides criteria on
the basis of which a pharmacist can determine whether a pharmaceutical raw
material contaminated with THC can be used in a preparation.
The reference point is the limit dose for THC
in food and the FAMHP is looking to the scientific committee of the Federal
Agency for the Safety of the Food Chain (FASFC) that has set thresholds for the
limit dose of THC in food of animal origin (i.e. for animals fed with hemp or
hemp derivatives).
The use of raw materials such as CBD with trace
amounts of THC for pharmaceutical preparations is acceptable if the maximum
dosage set by the FAMHP is not exceeded (i.e. if the patient’s exposure to THC
does not exceed 1 microgram per kg body weight per day).
Preparations based on CBD can only be delivered
on prescription. Free sale remains prohibited.
CORBUS ADVOCATEN specializes in all aspects of
the ever-growing market for cultivation and distribution of cannabis intended
for medicinal and scientific purposes.
For more information on this topic, please
contact Anton Buntinx (anton.buntinx@corbus.be).