As Korea moves to allow medical marijuana imports for self-treatment purposes from March 12, the government reiterated that the Korea Orphan & Essential Drug Center (KODC) would be the only authorized importer.

Epidiolex is the first cannabis-containing medicine approved by the U.S. Food and Drug Administration on June 25, 2018.

The Ministry of Food and Drug Safety held a briefing on the use of medical cannabis and raw materials at the Construction Management Training Center in Seoul, Thursday.

Hyun Mi-young, assistant director at the narcotics policy division at the ministry, said the government received inquiries such as whether a company could supply cannabis-derived products for the KODC after importing them directly or whether a distributor could supply them directly for patients.

Under the revised laws, patients with a rare or intractable disease must submit to the ministry an application to recognize them as eligible patients and a medical certificate (that displays the name of the treatment, and dosage per one time, the number of doses per day, and the total number of days for medication). Also required are medical records and a medical statement that there is no other alternative treatment in Korea.

After the ministry’s review, patients can get access to hemp-based medicines only through the KODC.

Patients have pointed out that such a procedure was too complicated and would take too much time to import medical cannabis.

Hyun said there has been criticism about why the only KODC was allowed to deliver marijuana-based drugs to patients. However, the ministry decided to allow the imports through the KODC only, to prevent the abuse and illegal distribution of the drugs, she said.

“Whether we should expand distribution channels needs a social consensus. To tackle concerns over a delay of supply, we will make every effort to import the drugs as soon as possible and distribute them,” she said.

Hyun requested the pharmaceutical industry to share any information about medical cannabis other than the four items eligible for imports.

The four medicines allowed for import are epilepsy treatment Epidiolex (ingredient: CBD), Marinol (dronabinol), Cesamet (nabilone), Canemes (nabilone), and Sativex (THC/CBD).

Except for the four, the government will continue to prohibit imports and the use of unauthorized food containing marijuana, hemp oil, and cannabis extracts.

lhs@docdocdoc.co.kr

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