Shipment may be ready to leave the warehouse, but then a delay at the border can occur. This can be caused by issues with documentation, batch details, or import approvals. While it can be frustrating to find out why there is a delay, it doesn’t really matter to the site as they just want their treatment.
There are many reasons for this, including complexities with customs, logistics, and cold chain management. Importing can be planned.
What Clinical Trial Import Requirements Should You Consider Early?
Delays usually occur from a few simple issues. Documentation may not be complete or not consistent between shipments. Batch details may not be what the receiving country expects. Labelling may need to be adapted to meet local requirements, and approvals can take time.
When designing a study for one country, these issues can be easily overlooked. However, when trials are expanding to new markets, these are more likely to occur.
What import rules should we consider early?
This can vary depending on the country, product, and study design. It is best to speak to both your regulatory and logistics teams for the correct list. The European Medicines Agency provides guidelines on clinical trials, which can give you some insight into the regulatory requirements.
However, there are a few common questions:
- What documents are required to ship to each receiving country?
- Will the product require specific labelling or specific language on the packaging?
- What batch documents are required to be sent with the shipment and who has them?
- How long does it usually take to get import approvals per market?
- Who is responsible for each part of the process if there is an issue?
Asking these questions prior to placing your initial order will allow you time to resolve any issues. Usually, if there is an issue with the shipment, you won’t have time to resolve it.
Using a Local Supply
Sometimes comparators can be easy to purchase in one country but difficult to import. Therefore, it is best to source from the destination country. Some studies use a local supply; others use a centralised supply. Both options have pros and cons with documentation, lead time, and risk.
Neunco provides country-specific comparator sourcing services, including sourcing from specific markets and batch selection. This can help you ensure you are sourcing from the correct location. Depending on your product and markets, there may be a suitable option.
Plan in Time for Import
Import processes can take time. By building this into your timeline from the start, you won’t be caught out if anything goes wrong. If you don’t build time into your supply plan for the comparator to be cleared quickly, you won’t have any buffer. By building in time for approvals, documentation and shipment time per market, you will give your sites a realistic delivery time.
Simple steps such as ordering earlier for new markets, ensuring documentation is correct with the receiving sites, and having a clear owner for each part of the import process will help. These are simple to do but often are not done, causing a delay.
Have Consistent Documentation
Having documentation that isn’t consistent will cause issues. If one shipment has a batch certificate and another doesn’t, this will cause a delay with the customs and site staff. Having a set documentation pack that is checked before sending will help avoid this.
Having consistent documentation will also help if the shipment gets audited. If teams have consistent documentation for all batches, they won’t have to spend time trying to piece together what happened.
Plan Contingencies
Sometimes even with everything planned, the shipment can still be delayed. It is best to have a plan in place for this. This could be shipping from an approved source, using existing buffer stock, or changing the treatment visit. However, whatever you do needs to meet the protocol and regulatory requirements. Neunco has an international sourcing network which can help you understand what options you have. Depending on your product, study, and destination, there may be an option.
Adding a New Country?
This is the perfect time to check the import requirements. A new market may require extra documentation, approvals, or labelling. By checking this before adding sites, you give yourself time to prepare.