South Korea Ministry of Health

Ministry of Food and Drug Safety Pharmaceutical Traceability Requirements

Global Regulations

Labelling

Products are required to display information in writing.

Unit Level Traceability

Sellable units are uniquely identified enabling a more granular traceability.

Aggregation

The packaging hierarchy of products is required to be identified and documented.

Central repository

The traceability documentation is required to be centralized in a unique system.

Ensuring Pharmaceutical Integrity through Compliance with South Korea's Traceability Standards

In the dynamic realm of South Korea's pharmaceutical industry, compliance with traceability requirements is a cornerstone of responsible and secure pharmaceutical practices. The Ministry of Food and Drug Safety (MFDS) in South Korea has established stringent regulations to ensure the safety, authenticity, and traceability of medicinal products within the supply chain centered on the Korea Pharmaceutical Information Service system.

Read Official Regulation

South Korea Ministry of Health

Key Highlights of South Korea's Pharmaceutical Traceability Requirements

Unique Identification and Serialization

Products are mandated to carry a unique identification code and serialization, enabling precise tracking and tracing throughout the supply chain. This serialization acts as a digital fingerprint, ensuring the authenticity of pharmaceuticals.

Data Reporting at Every Stage

Companies must meticulously report data at various stages, including production, distribution, and sales. This comprehensive reporting system allows regulatory authorities to monitor the movement of pharmaceuticals, swiftly detecting any irregularities.

Compliance Oversight

The regulatory framework is supported by rigorous compliance measures. Regular inspections and audits are conducted to assess adherence to traceability regulations, with non-compliance potentially resulting in penalties and regulatory actions.

Global Alignment

South Korea's traceability requirements often align with international standards, fostering interoperability and facilitating global trade in pharmaceuticals.

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Conclusion

As a pharmaceutical entity operating in South Korea, understanding and embracing these traceability requirements are paramount. Navigating this regulatory landscape requires a proactive approach, leveraging cutting-edge technologies and strategic partnerships to ensure compliance, transparency, and the highest standards of patient safety. Stay informed, stay compliant – empower your pharmaceutical business for success in South Korea's regulated pharmaceutical environment.

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