A Russian-based veterinary pharmaceutical company seeking registration of a product line for the EAEU market.
2. Project Challenge
The client faced a regulatory classification ambiguity:
- The product set consisted of two components used in combination — a veterinary medicine and a medical device.
- The client was uncertain which regulatory pathway to apply for — whether to submit the set as a single entity, as separate products, or under a combined registration framework.
- An incorrect pathway selection would have resulted in rejection, procedural delays, and additional costs.
3. Soloreg's Scope of Work
Soloreg conducted a regulatory pathway assessment and provided a structured resolution:
- Product Classification Analysis: Performed a detailed review of the combined product set to determine the applicable regulatory category under EAEU rules for veterinary products.
- Regulatory Pathway Determination: Identified the correct registration procedure for a combined medicine–device set, ensuring compliance with the relevant EAEU technical regulations and registration requirements.
- Application Preparation: Guided the client through the dossier preparation and submission process in accordance with the determined pathway.
- Regulatory Liaison: Provided ongoing support in interactions with the competent authority to address any classification-related queries.
4. Project Outcome
Metric | Result |
Regulatory Pathway | Correctly identified and applied for the combined medicine–device product set. |
Application Status | Successfully prepared and submitted in accordance with applicable EAEU rules. |
Client Impact | Resolved the classification ambiguity and avoided rejection due to incorrect pathway selection. |
Process Efficiency | Eliminated procedural delays and unnecessary re-submission costs. |
