VARIOUS players and individuals in the pharmaceutical as well as complimentary medicines sector have already submitted applications seeking approval to dispense hemp-based canabidiol products as complementary medicines.
By Michael Gwarisa
The Medicines Control Authority of Zimbabwe (MCAZ) recently put out a call to submit applications for registration in the form of a dossier as required by complementary medicines guidelines.
In an interview with HealthTimes, MCAZ Acting Director General, Mr Richard Rukwata said the response to their call has been overwhelming of late.
Quite a number of individuals have expressed interest in submitting their products for approval, and the Authority has since started receiving applications for approval of Hemp-base CBD complementary medicines,” said Mr Rukwata.
The complementary medicine product application fee is USD 600 per application and no applications have neither been approved nor disapproved as yet.
“The only condition is that the specified complementary CBD product should have been approved by the Authority. In terms of what conditions or ailments such products treat of address, it is up to the applicant to provide this information and we await sub-submissions to be included in the applications.”
Anyone who has acquired the approved complementary CBD product through the right channels, that is either in a retail shop or a pharmacy is eligible for a license.
The Government of Zimbabwe has gazetted three different Statutory instruments, two deal with industrial hemp and one deals with medicinal cannabis.
“It is critical to note that although HEMP and medicinal cannabis are related, they are grown under very different legal frameworks. There has been lot of confusion partly from the media with respect to these issues. Mbanje is still a highly controlled substance nationally and internationally and requires a special licence to grow it and to export it. HEMP is an agricultural product with lot of potential as a source of CBD oil which the Authority recognizes as a complimentary medicine. It is also a source of raw material for the textile industry and a source of food. Hemp has lot of potential, but it is not the same as medicinal cannabis,” added Mr Rukwata.
According to MCAZ, Product samples and certificates analyses detailing the amount of cannabidiols in the product and traces of the psychoactively intoxicating tetrahydrocannabinols are required. The suppliers and retailers of the hemp based CBD products must clearly specify the indications, warnings, contraindications among other information as part of product information in line with the complemetary medicines guidelines.
Satisfactory inspection of manufacturing site by the MCAZ inspectorate to ensure the site complies with Good manufacturing practices for the manufacture of complementary medicines will be conducted.
In their circular, MCAZ noted that selling of unapproved complentary medicines warrants prosection adding that products that are short of their conditions will be forfeited.
“Any Hemp based CBD product applications that do not meet the criteria above may not be approved for distribution and will be confiscated. Further, sellers may be prosecuted for selling unapproved complementary medicines.”
