Notice to applicants - type IA & IB variations

We kindly ask the applicants to submit the proposed national translations of SmPC, PL and Labelling at the the time of submission of variation applications where the product information is also concerned. We will circulate our comments with regards to the Hungarian texts during the international phase of the procedures. As soon as the variations are positively closed we will publish the updated texts on our website. Decisions for the type IA and IB variations are issued within 6 months after the closure of the procedure.

Please see the concerning guidelines:

Type IA:

http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_293_2013_Rev20_04_2013_cl.pdf

· Start of notification process (Day 0)

Type IB:

http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_294_2013_Rev19_2013_03_Cl.pdf

· 2.2 Validation of the application