In this article, we’ll cover:
- Background on the Proposed Customs Declaration Changes
- Details of the Expanded Declaration Data Fields
- Aim to Support National Drug Labeling Programs
- Approval Process and Timeline
- Perspectives from Industry Stakeholders
- Benefits and Challenges of the Changes
Background on the Proposed Customs Declaration Changes
The Eurasian Economic Commission has put forward proposed amendments to the customs declarations required for pharmaceutical products imported into the Eurasian Economic Union (EAEU).
The changes would allow importers to voluntarily submit additional details on pharmaceutical materials, including the CAS number, name, batch number, and volume.
Details of the Expanded Declaration Data Fields
Specifically, the proposed amendments would enable the following enhanced data fields on customs forms for EAEU shipments:
- CAS Registry Number – The unique identifier for chemical substances
- Name – The commercial or scientific name of the material
- Batch Number – The manufacturer’s batch or lot number
- Volume – The quantity or volume of the substance
These additional pharmaceutical import data fields would be optional to include.
Aim to Support National Drug Labeling Programs
The expanded declaration data aims to support drug labeling and traceability programs that some EAEU countries have introduced domestically.
For example, Russia launched a new drug labeling system in 2020 to track medications across the supply chain within its borders. Declaring batch details on pharmaceutical imports could help confirm that resulting locally manufactured medicines in Russia match the declared ingredients.
Approval Process and Timeline
The Eurasian Economic Commission’s Council will need to review and approve changes to the customs declaration format and instructions before implementation.
If approved as drafted, the pharmaceutical data fields could be available for voluntary declaration starting October 1, 2024. However, the typical regulatory review process takes around 9 months.
Perspectives from Industry Stakeholders
Pharmaceutical industry stakeholders have expressed both positive and negative views on the potential impacts of the proposed customs declaration changes.
Some note it could aid supply chain visibility and regulatory compliance efforts. But others are concerned about intellectual property risks or added compliance costs.
Galaxy Pharm, a full service logistics company with a focus on Ukraine and the EAEU, reports that they plan on implementing the changes for their partners if adopted. Galaxy Pharm expects the additional information to clarify and expedite the clearance process. Delta Medical, a partner of Galaxy Pharm, confirms this plan.
Benefits and Challenges of the Changes
There are a few key benefits and challenges that pharmaceutical firms should monitor with the proposed EAEU customs declaration changes:
Potential Benefits:
- Enhanced supply chain visibility
- Support for national traceability programs
- Smoother regulatory compliance
Potential Challenges:
- Disclosure risks of proprietary information
- Added compliance costs and administrative workload
- Uneven incentives across EAEU markets
With careful implementation, the changes present an opportunity to modernize customs processes for the pharmaceutical industry across the Eurasian Economic Union.
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