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General Guidelines
Written by Zdravko Mauko
Friday, 26 January 2007
New Legislation for Pediatric Medicines
On 23 October 2006, the Council of the European Union approved all the compromise amendments to the proposal for a Regulation on Medicinal Products for Paediatric Use which were agreed at its second Parliamentary reading. The Regulation was officially published on 27 December 2006 and will enter into force on 26 January 2007.
Requirement for GMP audit of API manufacturer by MAH
The implementation of EU directives 2004/27/EC and 2004/28/EC makes the requirement for marketing authorisation holder (MAH) to ensure that their Active Pharmaceutical Ingredients (API) have been manufactured to GMP.
Pliva gets first approval for biosimilar medicinal product (EPO)
Croatian pharmaceutical company Pliva has won its first European approval for generic erythropoietin, a biologic drug used for the treatment of low red blood cell counts.
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.
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.
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.
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