Europe Asks for Stakeholder Input in Refining and Harmonizing Its Variations Rules Across Member States

The European Commission (EC) has asked stakeholders to weigh in on its effort to further rationalize and harmonize the handling of variation filings across Europe.

The EC is looking at how best to extend the variation procedures it has worked out for applications regulated through its centralized and mutual recognition procedures to “purely national” marketing authorizations, for which the manufacturing change filing rules differ depending on the member state.  Over 80% of human and veterinary authorizations fall into this nationally-regulated category.

At the same time, the commission is seeking to adjust its variations process to focus regulator resources on the higher risk concerns in the wake of an expanding workload.

Two other issues for which the EC asked for input are: ● whether review timelines should be adjusted to allow more grouping of variations in a single application, and ● whether the variations procedure for authorizing human influenza vaccines for pandemic situations is sufficiently flexible.

A “public consultation paper” on the EC review of its 2008 variations regulation (1234/2008) was issued by the commission in September. The consultation period extended a month to October 22, 2011.

[More on the EC variations agenda and its relevance to advancing the quality regulatory paradigm internationally is provided for subscribers here. Nonsubscribers can purchase the full story for $95 by contacting Karen Bertani (  For subscription/license information, click here.]

Also see the following related IPQ coverage:

EMA’s IMP Guideline Will Provide Shelf-Life Flexibility and EU Harmonization

MHRA Has Been Rejecting One-Third of Type IA Variation Notifications Due to Information Shortcomings

IPQ May 2010 Report