National implementation of Commission Decision after a Community referral to arbitration

The Norwegian Medicines Agency implements CHMP arbitration updates nationally as the respective Commission Decisions are issued. It is expected that a fully updated documentation is sent to our Agency in order to implement the CHMP arbitration decision:
• Annex I SmPC in Norwegian *
• Annex III a-b  PIL and line listing in Norwegian **
• Annex IV (acceptable in English)
• Artwork (outer and inner) packaging sheets for the Norwegian market***
*Art 29, Art 30, Art 31       
**Art 29, Art 30        
 ***Art 29, Art 30

The Product Information texts in Norwegian shall fully correspond to the Product Information Annexes enclosed to the Commission Decision, including the paragraphs that are to be completed nationally.
The Norwegian Product Information should be sent in Word files tracked for the updates as result of the ended CHMP referral to arbitration to PI@noma.no.

For rules related to the national implementation process of a CHMP referral to arbitration (original product og generics) please see the ” Guideline on the details of the various
categories of variations to the terms of marketing authorisations for medicinal products
for human use and veterinary medicinal products”:

http://ec.europa.eu/health/files/betterreg/pharmacos/classification_guideline_adopted.pdf p.68
The Norwegian Medicines Agency hereby informs that the evaluation time for the review of the texts shall be additionally extended each time the texts do not comply with the requirements, as mentioned above.

Sist gjennomgått: 11.08.2010
Første gang publisert: 25.05.2009