CONTENTS
- 1. Violation of the Pharmaceutical Affairs Act | Overview
- - Definition Under the Pharmaceutical Affairs Act and Its Scope of Application
- 2. Violation of the Pharmaceutical Affairs Act | Main Types and Punishment
- 3. Violation of the Pharmaceutical Affairs Act | Administrative Disposition
- - License Revocation and Suspension of Qualification
- - Business Suspension Disposition
- 4. Violation of the Pharmaceutical Affairs Act | Penalty Surcharge
- 5. Violation of the Pharmaceutical Affairs Act | Methods of Response
- - Police Investigation
- - Administrative Procedure
- 6. Violation of the Pharmaceutical Affairs Act | Establishing a Response Strategy
1. Violation of the Pharmaceutical Affairs Act | Overview
A violation of the Pharmaceutical Affairs Act refers to a case in which obligations under the Pharmaceutical Affairs Act, established to ensure the safety and public nature of pharmaceuticals, are violated.
The scope of application is not limited to pharmacists and pharmacy founders; it includes all parties involved across pharmaceutical distribution, such as pharmaceutical companies, pharmaceutical wholesalers, medical institutions, and sales promotion agents (CSOs).
Under the Pharmaceutical Affairs Act, criminal punishment provisions and administrative disposition provisions coexist depending on the type of violation, creating a structure in which a single violation can give rise to multiple sanctions at the same time.
Definition Under the Pharmaceutical Affairs Act and Its Scope of Application
The Pharmaceutical Affairs Act is a statute enacted for the safe manufacture, distribution, compounding, and guidance on the use of pharmaceuticals, and it applies not only to pharmacists and pharmacy operators but also to everyone who handles or sells pharmaceuticals.
It is a core public health and medical law for protecting public health and maintaining order in pharmaceutical affairs.
In addition to pharmacists and pharmacy operators, the Pharmaceutical Affairs Act can affect pharmaceutical companies, wholesalers, and medical institutions.
Because it regulates the entire process from the manufacture of pharmaceuticals to their distribution, sale, and compounding, it is a law under which a mistake or violation can lead directly to criminal punishment.
2. Violation of the Pharmaceutical Affairs Act | Main Types and Punishment
For acts that violate the Pharmaceutical Affairs Act, the level of punishment varies according to the gravity of the violation.
| Major types of violation | Level of punishment |
|---|---|
· Where a person has had a license lent to them or has arranged the lending of a license
· Where a person who is not a pharmacist or oriental pharmacist has established a pharmacy
· Where a person has destroyed, damaged, or occupied pharmacy facilities so as to interfere with the duties of a pharmacist or oriental pharmacist, or has instigated such conduct
· Where a person has obtained a manufacturing business permit or amended permit, or has filed a report or amended report, by false or improper means | Imprisonment for up to 5 years or a fine of up to 50 million won |
· Where a person without a pharmacist license has used the title "pharmacist"
· Where a person has provided an economic benefit to a medical professional for the purpose of arranging or receiving prescriptions or soliciting patients
· Where a person has obtained approval or amended approval of a clinical trial plan by false or improper means
· Where a person has conducted a clinical trial without designation by the Minister of Food and Drug Safety
· Where a person has entrusted sales promotion duties to a party that is not a pharmaceutical marketing business operator
· Where a person has manufactured, sold, imported, stored, or displayed pharmaceuticals that do not meet the standards | Imprisonment for up to 3 years or a fine of up to 30 million won |
· Where a person has sold pharmaceuticals at a place other than a pharmacy
· Where a person has refused to compound a prescription without justifiable grounds
· Where a person has changed or modified a prescription and compounded it without the physician's consent
· Where a person has failed to obtain insurance or to explain or carry out compensation procedures
· Where a person has violated the duties of pharmaceutical manufacturing and production management
· Where a person has prepared or disclosed an expenditure report falsely
· Where a person has unlawfully sold pharmaceuticals, or has arranged or advertised such sales | Imprisonment for up to 1 year or a fine of up to 10 million won |
3. Violation of the Pharmaceutical Affairs Act | Administrative Disposition
A violation of the Pharmaceutical Affairs Act and related statutes may result in various administrative dispositions, such as license revocation, suspension of qualification, and suspension of business.
Because these dispositions are strict measures intended to secure public health and the safety of pharmaceuticals, thorough compliance with the relevant statutes is very important.
License Revocation and Suspension of Qualification
Where a pharmacist or herbal pharmacist falls under a statutory ground for disqualification, violates ethical standards, or commits another serious unlawful act, the Minister of Health and Welfare may revoke the license or order a suspension of qualifications for a fixed period.
License revocation occurs where a serious ground prescribed by law exists, such as mental illness, appointment of a guardian, narcotics addiction, or a sentence of imprisonment without labor or heavier.
Suspension of qualifications is imposed for a period of up to one year for relatively minor grounds, such as document forgery or noncompliance with an order, and the license may also be suspended where a reporting obligation is not fulfilled.
Even where a license is revoked, it may be reissued if certain requirements are met, and a disposition suspending qualifications may be enforced only within a certain period.
Business Suspension Disposition
Where a drug manufacturer, a pharmacy establisher, a drug seller, or the like violates the Pharmaceutical Affairs Act, all or part of their business may, by decision of the competent authority (the Minister of Food and Drug Safety, a Mayor, a County Governor, the head of a Gu, or the like), be suspended for a certain period.
The period of business suspension varies depending on the content and degree of the violation, but it may be imposed for up to one year, so particular caution is required.
Where a business suspension disposition is issued, it can cause serious disruption to business operations, and a loss of trust along with legal disadvantages may follow, so preventing the violation in advance is very important.
4. Violation of the Pharmaceutical Affairs Act | Penalty Surcharge
A system is in place under which a fixed penalty surcharge may be paid in lieu of a business suspension disposition, so depending on the violation, a penalty surcharge may be chosen and imposed instead of a business suspension.
A penalty surcharge may be imposed up to 100 million won for a pharmacy founder or herbal pharmacist, and up to 1 billion won for other pharmaceutical manufacturers, sellers, and the like.
In particular, where a pharmacy founder who has received a disposition suspending the qualification of a pharmacist or herbal pharmacist is subject to a penalty surcharge three or more times, further imposition of a penalty surcharge is restricted, and a business suspension disposition is imposed.
The subjects of a penalty surcharge, the standards for calculating the amount, and other necessary matters are determined by Presidential Decree, and the competent authority may request related tax information, sales data, and the like in order to impose a penalty surcharge.
If a penalty surcharge is not paid by the prescribed deadline, it may be converted into a business suspension disposition, or compulsory collection such as a disposition for default on national taxes may proceed, so a prompt response and payment can be needed when a penalty surcharge is imposed.
5. Violation of the Pharmaceutical Affairs Act | Methods of Response
If an investigation has been conducted for a violation of the Pharmaceutical Affairs Act or an administrative disposition has been imposed, a prompt and systematic response may be needed.
This is because an accurate understanding of the violation and proper compliance with the relevant procedures can significantly affect later legal outcomes.
Police Investigation
When a person is investigated by the police on suspicion of violating the Pharmaceutical Affairs Act, the statements made in the early stage of the investigation can be central to determining the overall direction of the case.
Statements that differ from the facts may lead to legal disadvantages later, so false statements should be avoided entirely, and consistency of statements should be maintained.
Before giving a statement, it is important to organize one's own conduct and the legal issues sufficiently and then approach the investigation.
Administrative Procedure
The administrative procedures arising from a violation of the Pharmaceutical Affairs Act include various administrative dispositions, such as license revocation, suspension of qualifications, suspension of business, and imposition of a penalty surcharge.
Where a disposition is announced or notified, the party must comply with the procedures for submitting opinions and filing an objection within the prescribed period.
Reviewing the procedural legitimacy and the substantive validity of the administrative disposition is also necessary.
Within 90 days from the date of becoming aware that the disposition was made, or within 180 days from the date the disposition was made
※ Period for filing an administrative litigation
It must be filed within 90 days from the date of becoming aware that the disposition was made, and within one year from the date the disposition was made
6. Violation of the Pharmaceutical Affairs Act | Establishing a Response Strategy
| Category | Key response point |
|---|---|
| Early stage of investigation | Control of statements, organization of internal materials |
| Criminal liability | Denial of intent, narrowing the scope of management responsibility |
| Administrative disposition | Building the rationale for mitigating the level of the disposition |
| Penalty surcharge | Review of whether there are errors in the calculation criteria |
| Combined response | Maintaining consistency between criminal and administrative strategies |
A violation of the Pharmaceutical Affairs Act does not end as a mere statutory violation; it is a complex matter that may lead to criminal punishment, business suspension, license revocation, and the like.
In particular, depending on the nature of the violation, criminal punishment and administrative disposition may proceed at the same time, and the outcome can be directly tied to maintaining the pharmacist's qualification.
In addition, pharmaceutical companies and CSOs may also face substantial disadvantages, so if you respond arbitrarily without legal understanding ahead of significant legal proceedings, the essence of the matter may be distorted or an unfavorable determination may result.
This firm comprehensively handles defense against criminal punishment in violation of the Pharmaceutical Affairs Act cases, as well as advisory and procedural representation related to responding to administrative dispositions.
In addition, depending on the characteristics and degree of the violation, criminal and administrative specialist attorneys collaborate to design a strategy suited to the client.
If you are facing difficulties due to a violation of the Pharmaceutical Affairs Act, 🔗medical specialist attorneys can work with you to establish a prompt response plan from the early stage of the case.
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