Institute of Immunology proposed corrective actions on deficiencies discovered in inspections
15.07.2015
Based on the Institute of Immunology’s application for granting manufacturing licenses for bacterial vaccines and manufacturing of blood and plasma derivatives and animal sera, in June 2015 HALMED conducted inspections in order to verify the GMP compliance.
Following to the inspection, Institute of Immunology d.d., submitted a written statement on discovered deficiencies with a proposal for corrective actions with deadlines for their implementation.
HALMED will reconsider the Institute of Immunology’s proposal and if needed, ask for additional justifications as well as evidence of undertaken measures. We would like to clarify that the deadline of 90 days until the HALMED’s decision does not count as long as the applicant has not submitted the requested justifications and evidence (clock-stop).
In spite of the public interest, we would like to emphasize that while these procedures are pending, no information could be provided as HALMED is bound to professional confidentiality.
HALMED will promptly inform the public on the results of procedures as soon as they have been completed.
