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General:

Equipment, intended for clinical trials conducted in Russia needs to be imported (custom cleared) just like any other piece of material being shipped for the same purposes.

Importation of equipment is considered to be the most complicated and requires thorough advance preparation to avoid clearance delays or even fines at the customs

Certification:

For importation of equipment the local certification of compliance is required. For the local certification of compliance the certifying body requires the description of the equipment in Russian and English including pictures, technical specification and other details. Starting from the January 1^st, 2013 every certificate of compliance will be accompanied by the test record sheet.

Notification:

Notification is a process of registering equipment or parts of equipment, containing cryptography – as per the Federal Security Service’s Centre for Licensing, Certification and Protection of National Security Information, such Notification has to be registered with the Centre and be recorded with the Customs Union Database.

Importation process:

The following documents must be provided for customs clearance of each shipment:

• clinical trial contract between the importing agent and the sponsor/representative (copy);

• study protocol synopsis (Russian, copy);

• CT Authorization (copy);

• certificate of compliance (Russian, original or notarized copy);

• Federal Security Service Notification letter for devices containing encrypting algorithms/modules;

• master airway bill (copy);

• proforma-invoice (English and translation into Russian, copies);

• packaging list (where applicable) — English and translation into Russian;

• other letters/documents from the sponsor/shipper upon request.

The sponsor/representative provides the documentation to a customs broker located at the appropriate customs office; the broker collates the documents, prepares a customs declaration, and submits to customs. The sponsor/representative liaises with the customs broker to resolve any problems with the importation of the clinical supplies.