Information on production material imported from the Republic of Korea in 2013
Based on the newly received information, upon the Customs Office reported about infliximab, imported from the Republic of Korea, the Agency for Medicinal Products and Medical Devices (HALMED) hereby would like to provide information related to the production material from the Republic of Korea in 2013, that attracts great interest from the Croatian public and media and is being incorrectly associated to the revocation of the Zagreb Institute of Immunology’s manufacturing license.
There were no finished medicinal products or human vaccines to be used in Croatian patients, or any other alternative to products of the Zagreb Institute of Immunology, but an intermediate product for manufacturing , was imported, more precisely the active substance infliximab that has never been manufactured by the Zagreb Institute of Immunology. The biological substance infliximab is a monoclonal antibody used in manufacturing of a new generation so called “clever” biological medicines and cannot be in neither way associated with the products by the Zagreb Institute of Immunology, hence this manufacturer has never been producing neither this substance nor medicinal products or any other medicinal product intended to treat patients with the same indication as infliximab. Therefore, we are highlighting once again that the import of blood products from the Republic of Korea in 2013, that attracted great interest from the public, has not been associated with the revocation of the Zagreb Institute of Immunology’s manufacturing license.
The large amount of the active substance was not imported from the Republic of Korea to the Republic of Croatia for the Croatian healthcare system, but for the needs of the entire EU and it was imported in Croatia, because a part of the manufacturing process of this medicine for the whole EU takes place in Croatia.