Aleksandrov, Mihail and Gelevska, Olgica and Stojova, Cvetanka and Ivanov, Ivan and Ananieva Bozinov, Lence and Maksimova, Viktorija (2023) Cannabidiol based borderline products – from development to registration processes. Macedonian Pharmaceutical Bulletin, 69 (1).
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Abstract
Cannabidiol (CBD) is the second most abundant
phytocannabinoid structure in Cannabis sativa L.,
Cannabaceae family. It contains a bicyclic 21-carbon
skeleton with a double bond in the terpene ring (Jacobs et
al., 2016). Cannabidiol based products have been used
mainly for additional treatment of pain, depression and
anxiety in cancer suffering patients as well as
immunostimulatory agents. They are used for treatment of
nausea and vomiting, especially during chemotherapy or
radiation therapy. Their effects are exerted through the
endocannabinoid system through multiple receptors,
including cannabinoid receptors (CBRs), opioid and
serotonin receptors, adrenergic receptors, and G protein�coupled receptors (Pertwee & Cascio, 2014). At high doses
can modulate the intoxicating effects of THC through CB1-
dependent mechanisms despite having low CB1 binding
affinity (Jacobs et al., 2016). In Republic of North
Macedonia, the production, use and sale of registered
cannabis products are regulated by the Law of Use of
Narcotic Drugs and Psychotropic Substances (Official
Gazette of R.M no. 37/2016). A borderline product is a
product that contains: (1)probiotics; (2)active components
of plant origin and it is classified as a food supplement in at
least one member state of the European Union, and
according to the special regulations applied in the Republic
of Macedonia, it cannot be classified as a food supplement;
(3)vitamins and minerals in quantities greater than the
permitted prescribed in accordance with the special
regulations applied in the Republic of Macedonia, if it is
classified as a food supplement in at least one member state
of the European Union and there is no registered product
with the same strength in the Republic of Macedonia
(Official Gazette of R.M no. 203/2015). According to the
second term of this law CBD products are still registered as
borderline products in our country.
| Item Type: | Article |
|---|---|
| Subjects: | Medical and Health Sciences > Other medical sciences |
| Divisions: | Faculty of Medical Science |
| Depositing User: | Viktorija Maksimova |
| Date Deposited: | 13 Dec 2023 11:42 |
| Last Modified: | 13 Dec 2023 11:42 |
| URI: | https://eprints.ugd.edu.mk/id/eprint/32890 |
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