What’s Inside the Q&A:

National Requirements

EMA approval is just the beginning. Critical country-specific steps including packaging and national license numbers.

Quality Person and Batch Release

Mandatory QP certification for every batch. How to establish EU import licenses and testing processes.

Serialization and Safety Compliance

EU Falsified Medicines Directive requirements for unique identifiers. Setting up connections to European verification systems.

Local PV and Compliance

Post-launch pharmacovigilance obligations. Ongoing compliance requirements and inspection readiness.