Institute of Immunology d.d. did not fulfil the conditions for manufacturing of sterile medicinal products and bacterial vaccines
25.03.2015
With regard to the annulment of HALMED’s decisions on rejection of manufacturing licenses to Institute of Immunology d.d. HALMED acted completely in accordance with the Medicinal Products Act and Act on the Common Administrative Procedure. Based on all relevant facts, it was concluded that Institute of Immunology d.d. at that time did not fulfil the conditions for producing sterile medicinal products and bacterial vaccines, which was unbiasedly discovered by a scientific Committee, composed of the Ministry of Health’s Pharmaceutical Inspector and HALMED’s experts.
Namely, in the case of the annulment of decisions, it is about different interpretation of the Medicinal Products Act and Act on the Common Administrative Procedure that in the end does not influence the scientific decision that Institute of Immunology at that time did not fulfil the conditions for manufacturing.
To support this, the fact that Institute of Immunology d.d. has never initiated an administrative appeal procedure against these HALMED’s decisions, which testifies that they did not contradict the established situation of having unmet manufacturing conditions.
