Customer Requirement
A leading American multinational pharmaceutical client required a Certificate of Pharmaceutical Product (CPP) that included a detailed composition, specifically covering all aspects of the solvent used in the formulation. The CPP was to be submitted to the Uzbekistan Health Authority (HA) as part of the product importation procedure.
Given Uzbekistan’s stringent documentation requirements, particularly around solvent identity, grade, concentration, and specifications, it was critical that the CPP be fully compliant to avoid regulatory delays and ensure continuous product importation.
Problem Statement
Following the CPP submission, the Uzbekistan team received a deficiency letter from the Health Authority indicating that the document lacked detailed solvent information. This omission made the CPP non-compliant and halted further regulatory progression.
The situation was urgent because:
- The Health Authority required a response within one week, including a corrected CPP.
- The standard CPP issuance timeline is 3–4 weeks, making it difficult to meet the deadline.
- The product importation was suspended until the issue was resolved.
Without immediate action, the client risked approval delays, regulatory non-compliance, and supply disruption in the Uzbekistan market.
Key Objective
To revise and reissue the CPP with comprehensive solvent details, including solvent identity, grade, concentration, and specifications, within one week, ensuring compliance with Uzbekistan HA requirements and restoring the client’s market operations.
DDReg Solutions & Processes Adopted
DDReg interacted with the relevant agency and coordinated closely with the Marketing Authorization Holder (MAH) to address the identified deficiency. Through this engagement, the necessary corrective actions were implemented, and the updated CPP including the required specifications was prepared and submitted to the Uzbekistan HA within the stipulated timeline.
Business Impact
By leveraging DDReg’s regulatory agility and global coordination capabilities, the client achieved:
- Rapid resolution within one week, compared to the standard 3–4 week process.
- Avoidance of import delays, maintaining uninterrupted product availability in Uzbekistan.
- Full regulatory compliance, addressing all solvent data deficiencies.
- Enhanced stakeholder confidence through efficient issue management and communication.
Key Learning
Even a minor omission in CPP details, such as incomplete solvent information, can result in regulatory deficiencies and import suspensions in markets with strict documentation requirements.
This case underscores the value of:
- Pre-submission data verification to ensure CPP completeness.
- Robust cross-border coordination between MAHs, consultants, and regulatory teams.
- Proactive, fast-track regulatory intervention to mitigate compliance risks.
With DDReg’s expertise in global regulatory management, clients can ensure swift issue resolution, sustained compliance, and seamless market continuity, even under time-critical conditions.
Read more client success story from DDReg here: Global Expansion Through MA Holding in Malaysia and Chile