The new variation Regulation

messages in brief | 22/03/2009

In 2006, after the completion of the major review of pharmaceutical legislation, the Commission published ideas to further improve the legislation of proprietary medicinal product variation applications.

The basic idea was:

  • Simplification of administrative processes
  • Harmonization of all procedures (national, MRP and CP)
  • Implementation of the ICH concept
  • etc.



After the Commission had offered all stakeholders various opportunities to comment on the new Variation Regulation as well as on the amendment of the EU Directive, the Variation Regulation EC/1234/2008 was published on December 12, 2008. This regulation is to be applied for the mutual recognition procedure and the centralized procedure as of 01.01.2010.


InnovationsTheinnovations of this regulation, which applies directly and does not have to be implemented in the national pharmaceutical law, are:

  • Revision and new definition of all categories of changes published in a Commission Guideline by the end of 2009.
  • Those changes that are not published in this guideline will automatically be classified as Type IB changes and no longer as Type II as before.
  • Possibility of immediate implementation of minor changes before they are reported to the authority ("Do & Tell"). On the one hand, certain minor changes (Type IA) must be reported immediately after implementation, on the other hand, there is the possibility of a summarized annual report.
  • The grouping of change requests according to certain rules is made possible.
  • To make procedures as efficient as possible, there are so-called "worksharing" procedures. This means that the assessment of a particular change request by a rapporteur is recognized by the other member states.
  • In case of existing disagreement between the member states concerned, there is now also the possibility of discussion in the CMD after amendment procedures.


This multitude of amended procedures, which will bring relief for both industry and authorities, will also apply to purely national procedures at a later date. However, a fully harmonized system will not be in place until mid to late 2011.


Further inquiry note