Regulation and marketing of cannabidiol-containing products in European countries. Pharmacists’ knowledge in Bulgaria

Figures & data

Table 1. Cannabidiol-containing products on the market in European countries.

Group	Product/preparation	Indication
Medicinal products	Sativex^®, 27 mg/mL THC, 25 mg/mL CBD (oromucosal spray)	Multiple sclerosis (MS) spasticity
	Epidyolex^®, 100 mg/mL CBD (oral solution)	Dravet syndrome, Lennox–Gastaut syndrome (orphan designation)
Magistral preparations	CBD + THC^a	Off-label: for moderate and severe persisting pain; others
Standardized preparations	Tilray^®, 10 mg/mL THC, 10 mg/mL CBD in oil (oral solution)	Add-on therapy to a standard treatment of MS, cancer pain or chemotherapy-induced nausea/vomiting
	Bediol^®, 6.3% THC, 8% CBD (granulate)	Various medical conditions or for good health and well-being as supplementation
Investigational new drug or supplements	Cannabidiol^b [7,9] (pharmaceutical grade CBD: oils, caps, spray, etc.)	Proposed for different medical conditions, including cancer and pain; for good health and well-being

^a THC, Δ⁹-tetrahydrocannabinol; CBD, cannabidiol.

^b According to US Federal law [9] the content of THC ≦ 0.3; In Europe, THC ≦ 0.2 is recommended.

Table 2. Data analysis of the approaches for medical use of CBD-containing products in European countries.^a

Country	Sativex^®a	Epidiolex^®a	MPs^a	CBD^a	Comments
Austria	Yes	Yes	No	Yes	CBD introduced in 2019 as IND^c
Belgium	Yes	Yes	Yes	Yes	Licensed CBD as POM^c
Bulgaria	No	Yes	No	Yes	CBD approved as FS^conly in 2019
Croatia	No	Yes	Yes	Yes	Tilray^® (oral solution in oil) as SP, POM^c
Czechia	Yes^b	Yes	No	Yes	Herbal cannabis preparations for limited medical conditions for an individual patient
Denmark	Yes	Yes	Yes	Yes	Licensed CBD for medical use as IND: CBD-oils from 3%
Finland	Yes	Yes	Yes	No	CBD as POM; Import, manufacture and advertising of CBD unauthorized as medicine is not allowed
Germany	Yes	Yes	No	Yes	SPs of medicinal cannabis
Greece	No	Yes	No	Yes	CBD (pharmaceutical grade) used only after a decision by a specialized National Committee
Hungary	No	Yes	Yes	Yes	CBD with a content of THC^c < 10 mg/kg; or any other cannabis seed derivative with a maximum content of THC < 0.2 mg/kg
Ireland	Yes^b	Yes	Yes	Yes	Cannabis-based products for medicinal purposes for a named patient through a special program
Italy	Yes	Yes	Yes	Yes	CBD, oral/ for inhalation; SPs
Norway	Yes	Yes	No	Yes	Specific approach: CBD-only generally regarded as a medicine; with THC content as narcotic. Recently introduced a case-by-case evaluation for CBD as IND
Netherlands	Yes^b	Yes	No	Yes	Pharmaceutical-grade CBD (unauthorized) distributed at pharmacies; SPs (Bediol^®); Many other forms of CBD: oils, caps, crystals, extracts, tea, functional foods
Portugal	Yes	Yes	No	No	CBD is considered a controlled substance
Slovakia	Yes^b	Yes	No	No	CBD as a controlled substance; THC as a narcotic
Slovenia	No	Yes	Yes	No	CBD as MPs
Sweden	Yes	Yes	No	Yes	CBD-specific approach; SPs (oral solution; oil drops)
Great Britain	Yes	Yes	No	Yes	CBD-specific approach as IND

^a Marketing authorization of the medicinal products Sativex^® and Epidiolex^® (Yes/No); Availability of: MPs, Magistral Preparations (Yes/No); CBD, other Cannabidiol (Yes/No).

^b Sativex is currently not marketed although it has marketing authorization. In some cases, it may be made available to patients through patient programs/compassionate use permit/named-patient import.

^c THC, Δ9-tetrahydrocannabinol; IND, investigational new drug; POM, prescription-only medication; FS, food supplements; SPs, standardized preparations.

Figure 1. Cannabidiol products availability on the Bulgarian pharmacy market.

Figure 2. Demand for CBD products on the Bulgarian pharmacy market.

Figure 3. Demand for CBD by patients’ age.

Figure 4. CBD: sole and simultaneous use.

Figure 5. CBD: use for medical conditions.

Figure 6. Pharmacists’ knowledge, awareness and attitudes towards CBD. Note: In red (dark): No/Negative; in blue (light): Yes/Positive.

CANNABIDIOL (CBD) Critical Review Report Expert Committee on Drug Dependence Fortieth Meeting Geneva, 4–7 June 2018. Available from: https://www.who.int/medicines/access/controlled-substances/CannabidiolCriticalReview.pdf

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Office of the Commissioner. Public Health Focus—FDA and Marijuana: Questions and Answers. 2018. Available from: https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421168.htm

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