To the attention of interested persons
In 2011, the National Agency for Medicines and Medical Devices (NAMMD) approved variation to marketing authorisation (MA) terms concerning the trivalent purified inactivated influenza vaccine (Marketing authorisation holder – INCDMI Cantacuzino) as regards its composition in accordance with composition approved by the World Health Organisation for the 2011/2012 season.
Following NAMMD approval, the Cantacuzino Institute has performed monitoring and monthly reporting to the NAMMD of outcomes of tests for each viral strain strength of the three viral strengths included in the vaccine.
To this date, monthly outcomes recorded have been within the approved quality parameters. The NAMMD has been informed from the latest tests performed on decrease in strength below the approved limit of one of the three viral strains in the vaccine composition.
The non-compliance submitted to the Agency concerned 7 out of the 18 vaccine batches manufactured. At the same time, the Cantacuzino Institute informed the NAMMD about initiation of the procedure for discontinued use of the 7 batches affected in view of recall.
The NAMMD provided prompt reply to the Cantacuzino Institute concerning measures required under such circumstances. Such measures mainly involve mandatory NAMMD information on vaccine amounts recalled as compared to those manufactured and distributed, respectively, for each non-compliant batch. At the same time, it is the MAH’s obligation to destroy all amounts recalled, in compliance with legal provisions in the field.
The NAMMD will further monitor outcomes submitted by the Cantacuzino Institute on quantitative composition of influenza vaccine batches.