The Amendment to the Korean Pharmaceutical Affairs Act 2019

The Korean Pharmaceutical Affairs Act (hereinafter as “Pharma-Act”) was proposed by the Chair of the Health and Welfare Committee of Korea on December 27, 2018. The Pharma Act shall adds more cumbersome regulations on the foreign qualifications of pharmacists, increases the limits of penalty surcharges and shall change the system to transfer a Korean pharmacy businesses. This Amendment shall become effective in July 2019. The major amendments are detailed below.

Key Highlights of the Korean Amendment to the Pharmaceutical Affairs Act

Criteria for the Qualification for the Korean Pharmacist Exam regarding Pharmacists Who Graduated from Foreign Colleges

The current Art 3 Pharma-Act, as part of Section 1 – Qualifications and Licenses of Pharmacists states that a person, which wants to become a pharmacist “…shall obtain a license from the Minister of Health and Welfare.” A license shall be granted if an individual has a bachelor’s degree from a national institution or a foreign college, as well as a passed a national pharmacist exam. After obtaining the license as a pharmacist in the Republic of Korea, these individuals can officially use the title “pharmacist.”

The Amendment enables the Minister of Health and Welfare to set criteria on foreign pharmacy colleges, thus, essentially making it more difficult for foreign-educated pharmacists from becoming pharmacists in Korea. To date, we are unsure if this shall effect those that are graduating from well-known foreign pharmacy programs.

The Korean Central Pharmaceutical Affairs Council

The Amendment, also, establishes a Central Pharmaceutical Affairs Council.

“A Central Pharmaceutical Affairs Council shall be established under the control of the Minister of Food and Drug Safety in order to respond to inquiries from the Minister of Health and Welfare and the Minister of Food and Drug Safety…” (Art 18 (1) Pharma-Act). The Amendment sets standards for the control of the composition of the Council with, only, a minority of members to be represented by public officials.

Mandatory Report of a Pharmacy Transfer

The Amendment changes the procedures for transferring management or ownership of a Korean pharmacy. If a founder of a pharmacy transfers his or her business to a transferee and the transferee wants to become the new founder, the transferee shall write a detailed report about the business transfer within a month of the transfer and provide it to the mayor of the city or other head of the place of the pharmacy’s location. This regulation shall be newly inserted to the current Art 21 (2) Pharma-Act, which states that “Each pharmacy founder shall manage his or her pharmacy in person: Provided, That where a pharmacy founder is unable to manage the pharmacy, he or she shall designate a pharmacist or a oriental medicine pharmacist who manages such pharmacy on his or her behalf.“

Increased Penalty Surcharges

In case of the suspension of the qualification as a Korean pharmacist or Korean oriental medicine pharmacist, the current Art 81 (1) Korea Pharma Act clarifies that the penalty surcharges for drug manufacturers and drug distributors etc. shall not exceed KRW 200,000,000. This limit shall be increased up to KRW 1,000,000,000. For pharmacy founders the limit shall be increased from KRW 50,000,000 to 100,000,000.

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