Subject: Other medical sciences
Year: 2023
Type: Article
Type: PeerReviewed
Title: Cannabidiol based borderline products – from development to registration processes
Author: Aleksandrov, Mihail
Author: Gelevska, Olgica
Author: Stojova, Cvetanka
Author: Ivanov, Ivan
Author: Ananieva Bozinov, Lence
Author: Maksimova, Viktorija
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.
Publisher:
Relation: https://eprints.ugd.edu.mk/32890/
Identifier: oai:eprints.ugd.edu.mk:32890
Identifier: https://eprints.ugd.edu.mk/32890/1/Aleksandrov%20et%20al.%2C%202023%20Ohrid%20Maced%20Pharm%20Bull_69.pdfIdentifier: https://eprints.ugd.edu.mk/32890/2/POSTER-kor.Aleksandrov-14th%20CESPT-Ohrid%202023%20%281%29.pdfIdentifier: 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).
