Question about medicinal cannabis (dry buds)
Pharmacists in Belgium may not legally dispense cannabis for medical purposes (Royal Decree dated June 11, 2015 on the regulation of products that contain one or more tetrahydrocannabinols).
The Committee for Medicines for Human Use (CMHU) formulated a recommendation about medical cannabis. Based on that recommendation, the competent authorities examined the possibility of dispensing medicinal cannabis (plant parts as a magistral preparation) in Belgian pharmacies. The file is very complex, the FAMHP cannot at this time predict when a decision will be made.
Doctors enjoy therapeutic freedom and can thus, in principle, prescribe medicinal cannabis. If you have a doctor's prescription, you can legally purchase medicinal cannabis in a foreign pharmacy. Bringing that same medicinal cannabis into Belgium may only occur with a Schengen declaration in your name. That is a document provided by the government of the country where the patient is registered that allows crossing the border with narcotic substances. (Article 75 (1) of the agreement for implementation of the Schengen Accord dated June 14, 1985 between the governments of the states of the Benelux Economic Union, the Federal Republic of Germany and the Republic of France regarding the gradual abolition of controls at common borders)
Only the FAMHP can validate this type of Schengen declaration in Belgium. Because it is prohibited to dispense cannabis in Belgium, the FAMHP will not validate any Schengen declarations to bring cannabis into the country. The police can
confiscate any imported cannabis. (Law dated February 24, 1921 regarding the trafficking of poisons, sleeping agents and narcotic substances, psychotropic substances, disinfectants and antiseptics and of substances that may be used for the illegal preparation of narcotics and psychotropic substances)
Questions about growing cannabis
Growing cannabis is currently not permitted in Belgium. The FAMHP can also issue no authorisation for this, not even for medicinal or scientific purposes.
There is ONE exception to this legislation: cannabis with a THC content less than or equal to 0.2% (hemp). Farmers who wish to cultivate hemp in whole soil (not in pots) can acquire an authorisation from the regional government. (In Flanders this is determined in the ministerial decree dated January 23, 2015 on the implementation of the decree by the Flemish government dated October 24, 2014 to determine the regulations for direct payments to farmers within the framework of subsidy regulations of the communal agricultural policy, with regard to the direct payments. In Wallonia, the European Directives (EU1307/2013, EU 1306/2013, R809/2014 and EU 639/2014) apply.)
If a country wants to permit cannabis cultivation, the government must set up a special agency for this. The cannabis agency will determine the surface area, location and who can cultivate the cannabis. Growers must transfer their harvest to the cannabis agency that will then govern further distribution. (Simple Convention regarding narcotic substances dated March 30, 1961 of the United Nations)
The law provides a legal basis to establish a cannabis agency under the FAMHP. (The law changing provisions regarding providing scientific and technical advised by the Federal Agency for Medicines and Health Products and regarding the financing of the Federal Agency for Medicines and Health Products as well as the establishment of a cannabis agency.)
But as long as the Royal Decree with the practical effects of the cannabis agency has not been published, the FAMHP cannot answer questions about the authorisation of cannabis cultivation.
The further elaboration of the law provides for three types of cannabis cultivation:
- Cannabis for scientific purposes;
- Cannabis as a raw material for the pharmaceutical industry: the cannabis agency would then approve the cultivation and the extraction of active substances;
- Medicinal cannabis: the cannabis agency organises the cultivation, takes possession of the cannabis and regulates the sale. This may occur via public tenders and sub-contracting.
The law provides for no changes in the prohibition of dispensing medicinal cannabis.
Possessing, using or dealing in cannabis seeds is punishable by law if they can develop into cannabis plants with a THC content of more than 0.2%.
(Law dated February 24, 1921 regarding the trafficking of poisons, sleeping agents and narcotic substances, psychotropic substances, disinfectants and antiseptics and of substances that may be used for the illegal preparation of narcotics and psychotropic substances)
Cultivating cannabis plants that result in cannabis with a THC content of higher than 0.2% is illegal7. Confiscation and destruction of plants discovered is obligatory.
A communal guideline from the minister of justice and the attorneys general determines the criminal policy.
Associations that combine individual harvests for personal consumption by their members are illegal and subject to criminal prosecution7. This is namely the facilitation of someone else's use of narcotic substances.
In addition, implementing these practices within the framework of an association is considered aggravating circumstances under the law dated February 24, 1921 regarding the trafficking of poisons, sleeping agents and narcotic substances, psychotropic substances, disinfectants and antiseptics and of substances that may be used for the illegal preparation of narcotics and psychotropic substances.
Questions about medicines based on cannabis, CBD or THC
Pharmacists may dispense medicines based on cannabis by medical prescription. In Belgium there are currently two medicines approved that are cannabis based: Sativex® and Epidyolex® (not yet commercialised).
Pharmacists may also dispense magistral preparations based on the pharmaceutical raw material cannabidiol (CBD) if they follow the conditions in circular 648.
Sativex® is a medicine approved in Belgium based on a cannabis extract and contains delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).
Treatment with Sativex® is indicated to alleviate symptoms in adult patient with moderate to severe spasticity from multiple sclerosis (MS):
- if they do not sufficiently respond to other medication for spasticity;
- and if their spasticity related symptoms have clinically significantly improved during a first test treatment period.
Sativex® is only reimbursed:
- for the patients described above;
- if they have a medical prescription from a neurologist for it;
- and if the hospital pharmacy dispenses the medicine.
The studies and trials that must show that Sativex® is also indicated for analgesia are not currently concluded.
If the results of studies and trials are positive, the authorization holder of Sativex® can submit an application to add “analgesic” to the indication of Sativex®.
After the FAMHP has evaluated the file, it can acknowledge the extension of the indication. After that the RIZIV will decide whether there will be reimbursement of Sativex® for the new indication.
Belgian law also allows for the submission of an application for a medical emergency programme. Thanks to such an emergency programme, a patient can use an approved medicine for an indication not yet approved. Via the attending physician, contact the authorisation holder to submit this type of request. (Article 6 quater (1) (3) of the royal decree dated March 25, 1964 on medicines, and article 108 of the Royal decree dated December 14, 2006 regarding medicines for human and veterinary use)
Sativex® is subject to a limited medical prescription: in principle, a neurologist must issue the prescription. But doctors in Belgium enjoy therapeutic freedom.
A treating physician can prescribe Sativex® under their own responsibility:
- if he or she finds that responsible for a patient;
- if he or she has fully and correctly informed the patient of the possible risks and the patient agrees to the treatment.
The FAMHP advises patients to discuss this with their treating physician. Sativex® prescribed by a doctor who is not a neurologist is never considered for reimbursement.
However, in that case there is no reimbursement. This is only for Sativex® dispensed in a hospital pharmacy.
Pharma Logistics nv distributes Sativex® in Belgium. Wholesalers can order Sativex® from this company.
Yes. But only if they are medicines.
Products based on CBD may meet the definition of a medicine:
- depending on the composition (daily dose of CBD);
- if the manufacturer includes the therapeutic indications (e.g. “analgesic”, “promotes sleep”, “stress-reducing”) on the package or in the information and advertising of the product. Advertising can be written and oral: testimonies and user experiences on web pages are an example of this. Website administrators must keep active oversight and remove non-compliant posts).
Only pharmaceutical companies may manufacture and distribute these type of products and only pharmacies can sell them. Manufacturers may market them only if they have a marketing authorisation for them.
The European Medicines Agency recently granted an authorisation to market the medicine Epidyolex in Europe. The marketing authorisation holder (manufacturer) determines itself the European member states in which it will market the product. It is currently unclear whether that will be the case in Belgium. Only Sativex is currently for sale in Belgium, but that is a medicine based on a combination of CBD and THC. For more information on the approval procedure for medicines based on CBD, see email@example.com.
Pharmacists can dispense magistral preparations with CBD with a prescription if the meet the conditions in circular 648. This type of magistral preparation is a medicine and thus falls under the authority of the FAMHP. Patients using these types of magistral preparations (such as CBD oil) may ingest a maximum of 1 microgram Δ9-THC per kg of body weight per day.
Questions about cannabis in foodstuffs and other products
The FAMHP is only the authority for products that are sold in a pharmacy as a medicine. Other products that contain CBD or parts of a cannabis plant with a THC and THC acid content not higher than 0.2% fall under the authority of FPS Public health, Safety and the Food Chain and Environment.
The law considers nutritional supplements enriched with CBD as novel foods. Manufacturers of novel foods may not sell them without prior authorisation. No nutritional supplement with CBD has received such an authorisation.
No. But for one exception.
In Belgium, it is forbidden to sell hemp-based nutritional supplements and other foodstuffs and preparations as foodstuffs. For certain types of foods, a deviation may be permitted. The THC safety limit for foods is much lower than the limit of 0.2% that applies to other products. For herbal tea/tea with a basis of leaves and buds of hemp there is never a deviation permitted, even if the THC content is very low. (Royal Decree dated August 29, 1997 regarding the fabrication and sale of foodstuffs comprised of plants or plant preparations or that contain these)
You will find more information about foodstuffs enriched with CBD on the website of the Federal Agency for Food Safety and the Safety of the Food Chain. You can also send questions in an e-mail to firstname.lastname@example.org.
Yes, but only if they meet strict conditions.
Cannabis extracts and tinctures are prohibited, with the exception of extracts that are exclusively made from seeds and leaves and thus not from the blooming or fruit-bearing buds of the cannabis plant. (Point 306 in annex II in the European Directive (EU) no. 1223/2009 regarding cosmetic products, that prohibits the ingredients in table I and II of the Single Convention regarding narcotic substances signed in New York on March 30, 1961)
The party responsible for marketing in the European Union must also make up a technical file for each product and provide it to the authorities consistent with the provisions of European directive 1223/2009.
Questions about CBD-based cosmetics? Send them in an e-mail to email@example.com.
Some dealers sell CBD-based products under the statute for herbal products intended for smoking. That is permissible if the products meet certain conditions:
- The THC content must be lower than 0.2%.
- Dealers must not sell them as herbal tea or potpourri.
- They may not assert that they have health benefits (therapeutic indications), such as “analgesic”, “stress-reducing”, “promotes sleep”.
- The products must bear a fiscal symbol because they are considered smoking tobacco-equivalent products subject to excise duty. More information about this? Send an e-mail to firstname.lastname@example.org.
Some dealers sell CBD based products as vapour liquid for electronic cigarettes. They too must meet the criteria above.
You will find more products about herbal products for smoking on the website of the FPS Public Health, Safety of the Food Chain and Environment. Do you still have questions? Sen them in an e-mail to email@example.com.
Dealers may sell products such as plant parts for decorative uses. But only if the products:
- are not intended for human or animal consumption, not even implicitly;
- have absolutely no direct or indirect claims to health benefits (therapeutic indications).
In that case, the general legislation on products safety applies and the marketing authorisation holder can be contacted if there are any problems.
It is prohibited to market a medicine, nutritional supplement or herbal product for smoking (such as potpourri) in this way.