Zero Days Repeat Use MRP
This refers to a simplified Mutual Recognition Procedure (MRP), which is completed on day 0, with an with Cyprus as the only Concerned Member State (CMS) or other Member States which adopt the RMS assessment report in its entirety and agree on the simplified timeframe. In order to request this procedure, the applicant must submit the Letter of Intent to the Medicines Council in a predetermined form (Φ.Υ.164).
Zero Days initial wave MRP
This refers to a Administrative Zero Days Mutual Recognition Procedure (Inititial Wave). which can be used for medicinal products which have a national marketing authorisation in an EU Member State and for registration in another Member State the MRP must be followed.
The procedure is administrative in nature and is completed in the Reference Member State upon commencement of the procedure (day 0) after the submission of a validated application. In order for this process to take place, the applicant must submit the Letter of Intent to the Medicines Council in a predetermined form (Φ.Υ.167).