SIDC as RMS for 2011
Článok
Obsah
In case, the applicant would like to ask for a slot in 2011 with SIDC acting as RMS for MRP or DCP procedure, common CMDh template is requested:
The request should be sent back (to kyrczova@sukl.sk) until 30.4.2010 at latest. During May 2010, it will be decided by management meeting (based on free scientific and personnel capacities), for which application submitted, the SIDC is able to act as RMS. The applicant will be consequently informed by the end of May, beginning of June 2010.
In period 2010 - 2011, SIDC is specializing on assessment of abridged MAA where BEQ is used as a mean of demonstrating similarity against the reference product.
In total, there are 12 free slots allocated for 2011 with SIDC a s RMS.