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 ”See 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” (see page 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.
The Norwegian Medicines Agency encourages the generic product MAHs to apply for a type IB or Type II variation, according to the Variation Regulation, for updates of their products after an original/reference medicinal product has been updated by a CHMP referral Art 30 Dir. 2001/83/EC (see section 4).
It is suggested that Art 31 Dir 2001/83/EC updates of the original/reference medicinal product are followed by the generic products’ updates.
OTC packages: No subsequent update of the OTC packages after finalised Art 30 and 31 of Directive 2001/83/EC in CHMP referral to arbitration for the medicinal product. Any updates of the OTC packages for the medicinal product in question shall be proceeded with a variation application according to the Classification Guideline for the Variation Regulation 1234/2008/EC.
Contact information
Tatjana J. Aune, Senior Executive Officer
Section for Product Information, Regulatory Affairs
Email: Tatjana.aune@noma.no
Sist gjennomgått: 23.11.2011
Første gang publisert: 25.05.2009