FAQs

In order to apply to Medicines and Medical Devices Agency of Serbia (ALIMS) for obtaining Import License one needs the following: General approval for conducting the clinical trial in Serbia, Proforma invoice, the original statement from the Principal Investigator, the Authorization for the approved Importer by the Sponsor.

The request is submitted to the Medicines and Medical Devices Agency of Serbia (ALIMS) and the following documents are needed: General approval of the clinical trial issued by ALIMS or the Letter of Formal Completeness, the original statement from the Principal Investigator, Letter of Authorization from Sponsor/CRO.

Import licenses for medication and other medical supplies have no expiration date.

If the entire quantity of medication and other medical supplies, indicated on the import license, is imported before the end of the clinical trial, it is necessary to obtain a new license.

Export licenses issued by the ALIMS are valid till the end of the clinical trial.

Upon regulatory approval for conducting the clinical trial in Serbia is issued, import / export licenses are issued and received in the period of 5 - 10 days.

The final batch releaser is considered as the manufacturer of the study medication.

When importing a medication, 10% VAT is paid on the total value of medication in addition to customs duty. For other study material, 20% VAT is paid on the entire amount of the invoice in addition to customs duty.

Since Serbia is not a member of the European Union, imported medications are subject to customs clearance. In order to clear the medications through customs and deliver it to the end user-research center it is necessary that a licensed importer clears the consignment.