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KMID : 1142220220170010011
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Regulatory Research on Food, Drug & Cosmetic
2022 Volume.17 No. 1 p.11 ~ p.18
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Policies on Using Personal Importation of Medicine
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Kang Dae-Won
Kim Sang-Yo
Kim Sang-Hyun
Choi Sang-Eun
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Abstract
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Due to the increased demand for various drugs, the importance of regulations on importing unapproved drugs by individuals into Korea is increasing. This study reviewed policy implications by comparing the regulatory status of personal import of medicines in the United States, Canada, Japan, Singapore, Australia, and New Zealand. In Singapore, Australia, New Zealand, and Canada, importers or their immediate family members can use personally imported medicines, and other countries did not specify them separately. In the United States, Canada, and Australia, the standards for bringing medicines from abroad differ depending on whether the importer has permanent residency or citizenship. There are different regulations on prescription drugs, over-the-counter drugs, and psychotropic drugs in most countries. In Korea, drugs within the scope of custom clearance exemption are worth USD 2,000 or less with a letter of recommendation issued by the head of the Korean orphan & essential drug center. On the other hand, in the case of the United States, Canada, Singapore, Australia, and New Zealand, the upper limit of drugs brought in is three months supply and two months supply in Japan. To harmonize international standards and reduce confusion, we suggest that the maximum dose of 2 to 3 months be a standard for personal drug importation.
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KEYWORD
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Personal Importation of Medicine, Unapproved Medicine, Policy Comparison, Customs Act, Pharmaceutical Affairs Act
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Listed journal information
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