News and Educations

Inspections in Institute of Immunology started


HALMED will conduct audits from 8th to 12 June 2015 in Institute of Immunology d.d., due to establish whether the manufacturer complies with Good Manufacturing Practice. This audit upon Institute of Immunology’s application for granting a manufacturing license for bacterial vaccines and manufacture of medicinal products derived from human blood or plasma and sera of animal origin.

Since there are applications for two manufacturing licenses, two individual procedures for granting a manufacturing license take place and therefore also two audits in Institute of Immunology. Each audit is conducted by a HALMED’s Committee, composed of a senior inspector, inspector and lawyer.

Decisions on granting or rejecting the two manufacturing licenses to Institute of Immunology d.d., will be taken following the entire procedure of granting/rejecting manufacturing licenses, where audits make only a part of the procedure. HALMED will complete these procedures as a priority, but when the decision will be taken depends on the applicant and how fast he will respond to eventual deficiencies. Namely, under Medicinal Products Act, the deadline for granting or rejecting manufacturing licenses is 90 following submission of a valid application, where the deadline may be prolonged for a clock-stop period needed by the applicant to prepare written justifications during the procedure.

Following the completion of audits, the concerned inspectors of the Agency will prepare a report on GMP compliance within 30 days and send it to the applicant. In the case that deficiencies have been discovered during the audit, Institute of Immunology will be obliged to reply in writing with their proposals for corrective actions and alleviation of deficiencies no later than 30 days from the date of inspection.

Based on the two inspection reports and in the case of eventual deficiencies and based on the applicant’s written reply, the concerned inspectors of the Agency will provide their opinion in writing on the GMP compliance. Final decisions on granting or rejecting each of these manufacturing licenses will follow.

We remind that Institute of Immunology requested a postponement of HALMED’s inspection in other to better prepare for the audit. Therefore, the inspection is being prolonged and carried in June instead of April this years, as previously planned.

The information on the procedure may not be provided publically, while procedure are in the course and will be made publically available once the procedures have been completed.