FAQs

Q?

What documents are needed to obtain an import license for the medication that is the subject of clinical trials and for the other study material?

A.

In order to apply to Medicines and Medical Devices Agency of Serbia (ALIMS) for obtaining import licenses you need the following: General approval for conducting the clinical trial in Serbia, proforma, the original statement of the principal investigator, the authorization of the approved importer by the Sponsor and administrative taxes.

Q?

What documents are needed to obtain an export license for the export of biological material of participants in clinical trials?

A.

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

Q?

Does an import/export license have an expiration date?

A.

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.

Q?

What is the deadline for obtaining import/export permits?

A.

The deadline for issuing import/export licenses is 30 days.

Q?

Who is considered a manufacturer of the study medication?

A.

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

Q?

How much is VAT on the import of the medication and other supplies for the clinical trial?

A.

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.

Q?

Can the medication be delivered from foreign suppliers directly to the research center?

A.

Since our country 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.