This section is about Pharmaceutical Regulatory Affairs
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Regulatory Affairs News
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Written by Zdravko Mauko
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Thursday, 29 December 2005 |
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.
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Read more...
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Regulatory Affairs News
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Written by Zdravko Mauko
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Friday, 16 December 2005 |
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
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