Korean Healthcare Products: EU Market Entry & Regulatory Support

COSMETICS

Cosmetics

• Coordination with an EU Responsible Person (RP) and qualified safety assessors for CPSR/PIF preparation.
• Coordination of CPNP notification preparation, plus label and claims review and country-specific launch readiness.

CPNP is an EU cosmetic product notification system; it is not pre-market approval or a certification.

MEDICINES

Medicines

• Screening of potential authorisation routes and information requirements against the product and target countries.
• Initial data-gap review and coordination or introductions to relevant pharmaceutical regulatory experts and EU partners.

EID coordinates specialist support; it does not itself perform regulated medicine-authorisation work.

MEDICAL DEVICES & HEALTHCARE PRODUCTS

Medical devices and related products

• Initial review of product classification factors and the likely regulatory route.
• Readiness and information-gap checks, with connections to relevant specialist bodies and regulatory partners.

Product classification and applicable requirements must be confirmed for the specific product by the relevant qualified parties.

PACKAGING

PPWR coordination

• Review of packaging materials, components, composition and available supporting records.
• Packaging-data readiness and coordination with the relevant packaging-compliance work.

CONDITIONAL CHECK

CBAM applicability

CBAM is checked separately only where the CN code of relevant packaging or another imported item falls within the applicable CBAM goods scope. We do not present CBAM as generally applying to finished cosmetics or medicines.