Investigational Medicinal Product (IMP) and Clinical Trial Materials (CTM) coordination
Biomapas proactively solves potential Clinical Trial Materials, IMP Coordination and Management process related issues and efficiently navigates challenging local import and export regulations. We have a well-established collaboration with local vendors in the service coverage area.
Some of the key terms to be aware of:
Investigational Product – is a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or once used to gain further information about an approved use.
Comparator (Product) – is an investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.
Clinical trial material – Laboratory kits, laptops, electronic or paper patient diaries, medical equipment, etc.
Rules and regulations of import/export IP and CTM vary from country to country:
- For example, In Lithuania as well as in other EU countries no customs clearance is required for importation of IMP (which contains non-controlled substances), study materials and equipment (e.g., laptop, ECG machine, test tubes) from the EU or EEA area. Sponsor should inform the RA about IMP (and related clinical trial supplies) imported from third countries. Export license for lab samples and tissues is not required.
- In Georgia the import license in not required. State Certificate issued by RA as an approval for the clinical trial is used for custom clearance purposes. Holder of State Certificate for clinical trial approval (local CRO or physical person) is authorized to be an importer. Name of imported medication as well name of Manufacturer in Proforma Invoice should match with data in State Certificate. Importation of comparators in frame of clinical trial requires Supportive letter from RA. After the customs clearance, IMP is sent to sites. Local Depot can also be used.
Most of the ancillary products can be imported without any import license. There is no label requirement for these items, if these products are not intended for sale or re-sale and provided only for the use in clinical trial. Customs clearance procedure is mandatory. Imported shipment should be accompanied by Proforma invoice with indication that this shipment has no commercial value, free of charge or clinical trial use only.
Export license for lab samples and tissues is not required.
- Similar process applies for Ukraine – RA approval is considered as Import License. Local depot is mandatory for storage and distribution of IP and CTM.
- In Belarus local depo company should be contracted to get IP in the country. Local depot should be legal entity registered in Belarus and having a license for pharmaceutical/medical activities issued by MoH of the Republic of Belarus. To receive IP in Belarus, the import license should be obtained before IP is sent.
This document can be obtained for multiple shipments or for a single shipment. In both cases, it is valid for 6 months from the date of issue. The actual amount of imported IP should not exceed the maximum planned amount indicated on the import license.
CTM can be locally sourced (if registered or available in Belarus) or imported. Most of the ancillary products can be imported without any import license. There is no label requirement for these items if these products are not intended for sale or re-sale and are provided only for use in a clinical trial. The customs clearance procedure is mandatory. The imported shipment should be accompanied by a proforma invoice indicating that the shipment has no commercial value, is free of charge, or for clinical trial use only. A technical description is desirable for customs. There are importation restrictions for mobile equipment. So called “notification” should be available for laptops, tablets, PC, smartphones etc. – they should be included in the state registry.
When central laboratory services are used, an export license is required for biological samples to be shipped outside Belarus. MoH issues an export license for shipping biological samples.
- Similar process applies for other CIS countries.
- Biomapas has long term successful cooperation with vendor companies in CIS countries and can provide import/export regulatory and customs support, delivery and transport, materials and equipment.