FAQs

Q?

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

A.

Since we are not members of the European Union, all imported goods are subject to customs clearance, ie. stops at customs. To clear the goods through customs and deliver to the end user-research center it is necessary that a licensed importer clears the consignment after which it may be delivered to the final destination.

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?

Who is considered a manufacturer of the medication that is under a clinical trial?

A.

Manufacturer of the medication that is tested is the manufacturer responsible for the release of the batch.

Q?

What is the wait time for obtaining import/export permits?

A.

The deadline for issuing import licenses is 30 days and the period for issuing export licenses is 15 days.

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 amount of medications and medical supplies which are planned and specified in the permit are sufficient until the end of the clinical trial.
If the entire quantity indicated on the import license is imported before the end of the clinical trials it is necessary to obtain a new license.
Export licenses issued by the Ministry of Health expire 4 months after the issue date. They must be revived if the study is active, ie. while there is a need for the export of samples of biological material.

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 Ministry of Health and the following documents are needed: the solution that the study is approved by the Agency, the original statement of the principal investigator and republic administrative fee.

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 ALIMS for obtaining import licenses you need the following: approval for conducting clinical trials in Serbia, proforma, the original statement of the principal investigator, certificate of analysis for the medication, the authorization of the approved importer by the Sponsor and taxes.