Introduction of additional fee for variation applications

A new fee will be introduced for variation applications Type 1B, leading to changes in the product information (Summary of Product Characteristics (SmPC), patient information leaflet and labeling)

From January 2010 the EC Regulation 1234/2008 came into force (concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products). By this regulation several variations, previously categorized as Type II, are now classified as Type IB. The Norwegian Medicines Agency has, as of today, just invoiced Type II variations.

The Type IB variations leading to changes in the Product Information (Summary of Product Characteristics (SmPC), patient information leaflet and labeling), requires a lot of resources at the Norwegian Medicines Agency.  The Ministry of Health and Care Systems has, after proposal from the Norwegian Medicines Agency, set the fee for these variations to NOK 8000,- . The fee is the same for both nationally approved products, applications for which we are Reference Member State and Concerned Member State.
The amount is reasonable compared to the resources used.

The Norwegian Medicines Agency is from the 1. of October going to introduce the fee of NOK 8000,-

Contact person

Inger Heggebø
Seniorrådgiver
Regulatorisk avdeling
Tlf: 22 89 77 44
inger.heggebo[at]legemiddelverket.no

Sist gjennomgått: 02.09.2010
Første gang publisert: 02.09.2010