Several key legislative changes are needed to make medical cannabis-based products available in Ukraine. The pharmaceutical sector must also be ready for this. Deputy Minister of Health and Chief State Sanitary Doctor Igor Kuzin told UNN, adding that if the business gets involved in time, the sale mechanism will be able to start working at the end of this year.
Details
When asked what issues need to be resolved in order to launch the mechanism for selling medicines based on medical cannabis, Kuzin answered: "Several major legislative changes are needed. The first legislative change is that cannabidiol and cannabis itself should be transferred to the appropriate gradations or qualifications in the list of narcotic drugs.
Kuzin reminded that he is now in the so-called first table.
"The first table means that these are psychoactive substances that are prohibited for use. Now we are talking about the fact that they should be transferred to another table, which can be used for medical purposes, for medical reasons. The second key document is a list of medical indications for the use of medical cannabis products," Kuzin said.
He explained that it is essentially a list of nosologies in which the Ministry of Health allows the use of medical cannabis products.
"Therefore, we have now worked together with experts, international experts, the State Expert Center, analyzed the evidence base, and have already prepared draft documents that are currently undergoing scientific discussion in professional circles and professional associations. Today, there are at least 12 nosologies. That is, these are diseases for which the use of such drugs is indicated," Kuzin said.
He noted that the third part concerns the list of dosage forms or types of dosage forms that can be used in the country.
"We are talking about an oil solution, or an extract, or some other form. Once all three documents are approved, it will be possible to actually use such drugs," Kuzin explained.
He also added that there is a related document.
"We all remember that such medicines should be dispensed by electronic prescription, so the finalization should be done by the group dealing with digital solutions. And pharmacies must go through the procedure of registration of the active pharmaceutical ingredient, that is, register this active chemical substance so that it can be used to prepare a drug in a pharmacy," said the Chief State Sanitary Doctor.
13.07.23, 11:21 • [views_685065]
When asked how long it will take to start selling and prescribing medicines based on medical cannabis, Kuzin answered: "After the signing, the regulatory documents should be adopted within six months, so we are focused on July or so, when all the regulatory documents should be adopted according to the law, but the legislative framework and the actual readiness of the pharmaceutical sector are slightly different things.
Therefore, he noted that an appropriate legislative framework can be created, but businesses may not be ready to import and manufacture medicines with medical cannabis.
The requirements are quite stringent, meaning that not all pharmacies will be able to pass, because in order for such drugs to appear in pharmacies, the pharmacy must have a license not only to sell drugs, but also to manufacture drugs in a pharmacy. Therefore, all this work is being done with representatives of pharmacy associations so that they understand the potential changes and are already preparing for these changes. Therefore, we hope that if the business gets involved in time, it will be able to start working at the end of this year. If there are any delays on the part of the business, we will address them on a case-by-case basis