Following the crisis in Ukraine, Oximio has resumed some operations, knowing that previously established supply chains and logistics models are no longer feasible. This is given to the destruction of infrastructure, stock limitations, and most importantly, as we prioritise peoples’ physical safety. We are developing new approaches that include storage and distribution services, direct-to-patient transport, the possibility of alternative importation schemes.
In this webinar we discuss the current clinical trial landscape in Ukraine, the challenges resulting from the war, and how to solution new logistics models to ensure that patients continue to maintain treatment.
- Regulatory requirements updates: IMPs import/export process, MoH`s requirement, update of licenses
- First hand perspective for Ukrainian market of clinical trials, current challenges, impact and consequence of the crisis
- Oximio’s operational capabilities: status of exist UA facilities, Oximio`s business continuity plan re-defining supply chain and services, factors influencing cost to serve
- Case-studies: How alternative solutioning has enabled patients to continue on trials in Ukraine
Q: What exactly is the process for zoning the country, conducting risk assessments, prioritising people’s safety – what does the decision-making look like?
A: Zoning is based on the official information of Ukrainian government regarding military actions in the regions of Ukraine. Managing Director in Ukraine has ultimate responsibility to decide about these zones on the daily basis, again considering official information. If we see any changes in zones, we will inform our customers accordingly.
Q: Are you able to provide inbound solutions? From which countries?
A: Yes, importis feasible, by road. In Hungary, we have a regional depot and can plan transit solutions in partnership with our clients, depending on requirements. We can also determine the feasibility of other import schemes. Please note that there are additional planning requirements including increased transit times, temperature control maintenance, further product handing (storage, transport). These will need to be discussed prior to any import plans being finalized.
Q: Can you perform customs clearance activities?
A: We can perform customs clearance and brokerage services for studies that we are managing. Customs at airports in Ukraine are not operational, as flights are suspendedbut we can perform these services at road bordersto support product import from neighboring countries. Note that IMP is not considered to be humanitarian aidbut that from 22 March, critical goods can be imported without VAT and other expenses at customs.
Q: Will all new imports into Ukraine be stored in the regional depot in Brody City?
A: No. The Brody depot will be used as a secondary contingency and a cross dock depot. As a main rule, imports will be handled in our central depot near Kiev. However, if imported products can be pre-allocated to Western Ukraine and Rest of Ukraine at the time of the importation, then we can use Brody for storing the stock pre-allocated for the west.
Q: Are procurement and comparator sourcing services possible? How?
A: Many vendors are still operating, have relocated their offices and warehouses to the West of Ukraine. Some of them are still located in Kiev Region. Oximio`s partners are continue to receive import shipments. So, we don`t see any issues with availability of products and have already done several comparator sourcing deliveries since the war started.
Q: From a MoH perspective, how are quality standards maintained during this time?
A: From one side, we know that Government and State Export Center simplified the requirements of:
- import, selling of medical products;
- transportation conditions (medicinal products could be delivered by public transport and in postal or baggage carriages provided).
Also it was adopted:
- exceptions for premises for storing medical products by licensed operators.
But from the other hand, the companies must comply with all quality requirements including the temperature storage conditions and general quality system rules.
So, we can say that we really see the simplification the process, but as we mentioned in our webinar – all companies should think about the concluding Amendments to MSA and TQA to revise operations part, quality questions, security and liabilities measures.
The parties will be able to put all new simplified requirements according to the new regulation for a period of Martial law in this Amendment that will be good mechanism for future cooperation.
Q: Would it be any solution for laboratory samples shipment to Central Labs in Europe?
A: We are under developing of this procedure. The new approach here is to arrange the export of bio-sample through the ground border check-point and faster delivery of bio-samples within the EU to the central lab.
At this moment each request we receive is reviewed on a case-by-case basis. For new logistics requests, please contact the project management team: firstname.lastname@example.org