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보도참고자료
보도시점배포 즉시배포2025. 2. 6.(목)식약처, 올해 의약품 소량포장 공급 대상 공고 – 2025년도 의약품 소량포장 의무 공급 대상 19,168개 품목 공고 – 정제·캡슐제·시럽제, 연간 제조·수입량의 10% 이상 소량포장 공급 의무 식품의약품안전처(처장 오유경)는 의약품 제조·수입자가 소량포장 공급 대상을 정확히 확인할 수 있도록 2025년도 의약품 소량포장단위 의무 공급 대상 1만 9,168개 품목을 2월 6일 공고*했다고 밝혔다. * ‘식약처 대표 누리집(www.mfds.go.kr) → 알림 → 공고’ 의약품 제조·수입자는 의약품 중 정제·캡슐제·시럽제의 경우 수출용, 희귀, 퇴장방지의약품 등을 제외하고 연간 제조·수입량의 10%를 소량포장단위로 공급해야 한다. 소량포장단위에 대한 수요가 적은 품목*은 공급 기준을 10% 이하로 차등 적용할 수 있는데, 필요할 경우 업체는 오는 2월 10일까지 한국제약바이오협회나 한국의약품수출입협회에 품목별로 차등적용을 신청할 수 있다. * 전년도 소량포장단위 출고 비율 10% 이하이며 재고량 3% 초과 품목 등<2025년 의약품 소량포장단위 의무 공급 대상 현황>제형공고 품목 수 (총 19,168개 품목) 소량포장단위정제16,335개 품목낱알모음포장: 100정·캡슐 이하 병포장: 30정·캡슐 이하캡슐제2,724개 품목시럽제109개 품목500mL이하 식약처는 앞으로도 소비자는 편리하게 사용하고 업계는 폐기 등 낭비를 줄일 수 있도록 의약품 소량포장단위 공급을 합리적으로 운영하겠다고 밝혔다.담당 부서의약품안전국책임자과 장 문은희(043-719-2651)의약품관리과담당자사무관한은경(043-719-2664)
Brief
"On "06/02/2025", the "Korea Food and Drug Administration (KFDA)" issued an update regarding "Ministry of Food and Drug Safety announces target for small-scale pharmaceutical packaging supply this year". The KFDA has announced that 19,168 pharmaceutical products will be subject to mandatory small-scale packaging from January 1. This includes categories such as purified liquids, capsules, and syrups."
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Purpose
The South Korean Ministry of Food and Drug Safety (MFDS) has released a press notice announcing the 2025 edition of the Pharmaceutical Products Packaging Regulation. The regulation aims to promote the use of small packaging for pharmaceutical products, making it easier for consumers to use and reducing waste in the industry.
This update is crucial as it establishes a clear guideline for manufacturers to follow when packing their pharmaceutical products. By setting a standard, the MFDS is promoting sustainability and efficiency in the production process, which will have a positive impact on both businesses and consumers.
Effects on Industry
The implementation of this regulation will have a significant impact on the pharmaceutical industry in South Korea. Manufacturers will be required to pack 10% or more of their annual sales volume in small packaging units, which may lead to increased costs for some companies. However, this move is expected to reduce waste and improve sustainability in the long run.
Additionally, this regulation will also affect suppliers and distributors, as they will need to adapt to the new packaging requirements. Companies that are not compliant with the regulations may face penalties or reputational damage, making it essential for them to adjust their practices accordingly.
Relevant Stakeholders
The stakeholders affected by this update include:
- Pharmaceutical manufacturers and importers
- Suppliers and distributors of pharmaceutical products
- Regulatory bodies responsible for enforcing the packaging regulations
- Consumers who will benefit from reduced waste and increased convenience
Businesses that need to adapt to the new packaging requirements should take immediate action. They must review their current practices, update their packaging systems, and ensure compliance with the regulations by the deadline.
Next Steps
To comply with this regulation, manufacturers should:
- Review their current packaging practices and identify areas for improvement.
- Update their packaging systems to meet the new requirements.
- Communicate changes to suppliers, distributors, and relevant stakeholders.
- Ensure that all products are packaged in small units by the designated deadline.
Any Other Relevant Information
The MFDS has emphasized its commitment to promoting sustainability and efficiency in the pharmaceutical industry. By implementing this regulation, they aim to reduce waste, improve consumer convenience, and create a more environmentally friendly production process.
To facilitate compliance with this update, the MFDS provides resources such as guidelines, training sessions, and online support tools on their website. This information is available for stakeholders who need to adjust their practices to meet the new requirements.
As this regulation takes effect, businesses should be prepared to adapt to the changes and ensure that they are in compliance by the deadline.
