Regulations (EC) No 1084/2003 and (EC) No 1085/2003 regarding variations in the Mutual Recognition Procedure and the Centralized Procedure
The new regulations will be put into force in the EEA 1 October, 2003. As for the now existing regulations on variations the new regulations will by 1 October 2003 also be put into force for purely national MA’s in Norway. The now existing assessment time for national variation applications will however, be maintained.
The main difference between existing and new regulations is the introduction of notifications. In short a notification is a variation which may take place without further communication, provided certain conditions have been met.
Below is a guide to necessary and useful internet addresses:
Regulation (EC) No 1084/2003:
http://pharmacos.eudra.org/F2/eudralex/vol-1/new_v1/reg_comm_1084_2003_en.pdf
Regulation (EC) No 1085/2003:
http://pharmacos.eudra.org/F2/eudralex/vol-1/new_v1/reg_comm_1085_2003_en.pdf
Guideline:
http://pharmacos.eudra.org/F2/eudralex/vol-2/C/GdVarTypIAB_rev0_200307.pdf
New application form:
http://pharmacos.eudra.org/F2/eudralex/vol-6/newdoc/newvarform_%20250703.doc
Guideline from the MRFG:
Best Practice Guide for the submission and processing of variations in the Mutual Recognition Procedure :
http://heads.medagencies.org/mrfg/docs/bpg/MRFG_BPGs_Jul03_final.pdf