Applications for type I variations to marketing authorisation of medicinal products authorised through the DCP/MRP, where the variation does not affect the summary of product characteristics, package information leaflet and package labelling (hereinafter referred to as the “texts”), shall be handled without issuing a decision on marketing authorisation variation or without issuing a notification of the implementation of marketing authorisation variation where applicable (where variations submitted before 1 January 2010 are concerned). This applies only to the variation procedures in which the Czech Republic is a participating member state.
As of 1 June 2012, the handling without issuing a decision on marketing authorisation variation shall also apply to type II marketing authorisation variations in the case of medicinal products authorised through DCP/MRP where the variation does not affect the texts. All marketing authorisation variations concerning products authorised through the DCP/MRP that were rejected by the reference member state shall be terminated without issuing a decision on the rejection of a marketing authorisation variation. This only applies to procedures in which the Czech Republic is a concerned member state. The rule also applies to previously submitted applications whose handling by the State Institute for Drug Control had not been terminated by the above date. The date of approval or rejection of the marketing authorisation shall be the date of termination of the procedure by the reference member state.
Marketing Authorisation Branch
21 May 2012
cz