Grubiša: We Have Not Yet Received a Request for Import of Lung Cancer Vaccine

The new Cuban Cimavax vaccine for the treatment of lung cancer could also become available to patients in the RS, local media reported, noting that if it proves to be an adequate treatment in Serbia, the University Clinical Center of the RS will initiate a procurement process for this vaccine, reports the Patria news agency.

However, as confirmed to us by the Agency for Medicines and Medical Devices of Bosnia and Herzegovina, for a medicine to be placed on the market in BiH, it must be registered, i.e., have a marketing authorization issued by this Agency.

The registration process, i.e., granting a marketing authorization, begins with the submission of a request for registration and marketing authorization in BiH. The request is submitted by the manufacturer or its representative with a registered office in BiH, if it is a foreign manufacturer – says Hataša Grubiša, director of the Agency for Medicines.

She added that so far they have not received a request from the manufacturer or its representative for the registration of the Cuban lung cancer vaccine in Bosnia and Herzegovina.

- If a medicine is not registered but is needed for the treatment of a specific patient or group of patients, it can be imported through emergency import. Emergency import, i.e., import of a medicine without a marketing authorization, is approved by the entity ministries responsible for health affairs – Grubiša added.