The new variation regulation – Implementation in Norway

From the 01.01.2010 the Variation Regulation will come into force. The Regulation describes variations to both veterinarian- and human products approved via the Mutual Recognition - , Decentralized- and Centralized Procedure.

EC/1234/2008 replaces the current EC/1084/2003 and 1085/2003.

With reservation in regards to the ongoing hearing on the legal implementation nationally, the Norwegian Medicines Agency will apply the same principles for all procedures.

For nationally approved products the hearing also suggest to follow the same procedures for nationally approved products, with the exception of longer timelines.

Nationally approved products:

• Variations Type IA and Type IA _IN: The variation is to be processed within 30 days
• Variations Type IB: The variation is to be processed within 60 days
• Variation Type II: The variation is to be processed within 120 days

The implementation of the work sharing procedure will have to be postponed until the nationally approved products in all EU/EEA countries are included in the EC variation regulation (expected 2011).

The longer timelines for nationally approved products is based on the current experience with these applications. This is however a transitional arrangement until nationally approved products formally are to be included the regulation.

See CMD(h)´s og CMD(v)´s ” Best practice guides for the submission and processing of variations in the mutual recognition procedure” for further information “.

Variations applications

Variations applications submitted after 01.01.2010 should be according to the new Variation Application form, while applications submitted prior to this date should be according to current Variation Application form.

See  Variation applications – What dates are to be included in the Product Information, and which responses are to be expected from the Norwegian Medicines Agency (pdf)

Sist gjennomgått: 17.12.2009
Første gang publisert: 17.12.2009