Non-essential modifications

A new resolution has set out the methods of communication of non-essential modifications to manufacturing sites and/or the importation of non-sterile active substances and those of a non-biological origin.  For the first year of application of the resolution, these sites must transmit the list of non-essential modifications that occurred in the period between 8th March, 2014 – 31st March, 2015 to the Manufacturing Site Authorization Office by 30th April, 2015. In the following years, the modifications will be notified by 30th April of each year with reference to the modifications that occurred between 1st April of the previous year and 31st March of the current year. The resolution also applies to manufacturers and/or importers in possession of valid GMP certificate who have already carried out the registration of their activities. It does not apply to manufacturers and/or importers of sterile active substances and/or those of a biological origin.