Regulatory Affairs - FarmavitaR - Regulatory affairs network

Regulatory Affairs

DMF project

Tuesday, 03 January 2006 11:43 Regulatory Affairs - General Gulielines

Timeframe for DMF development

Timeframe to development and submission of DMF is 8 to 9 months. In some cases when you have an experienced project team and when you are in a hurry timeframe could be squeezed to 4 months.

Data Exclusivity

Thursday, 29 December 2005 01:28 Regulatory Affairs - General Gulielines

New legal framework for harmonisation of the data exclusivity

The new periods of data exclusivity will only take effect for reference products applying for marketing authorisation after the new law is fully in effect (around November 2005). Therefore, the first generics applications under the 8+2+1-year data exclusivity period will not occur until late 2013.

New CADREAC

Friday, 16 December 2005 22:26 Regulatory Affairs - General Gulielines

Simplified MRP procedure for EU candidates

For the Czech R., Slovak R., Hungary, Croatia, Romania and Bulgaria there is simplified MRP procedure, also known as CADREAC prcedure. Because of simplicity of CADREAC procedure we suggest you to use this procedure for this countries, in cases when you have MA in RMS. Details about procedure could be submitted by Farmavita.

Please take a look at the official nCADREAC web site http://www.newcadreac.org/cadreac.html