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Norway > Legal Developments > Law firm and leading lawyer rankings

Editorial

Increased transparency for applications for marketing authorisation

On 17th July 2012, the Norwegian Medicines Agency (NMA) announced a change in their practice regarding disclosure of information for applications of marketing authorisations for medicinal products.

In the past, NMA has upheld a restrictive practice if someone wanted to know whether or not an application for a marketing authorisation for a medicinal product had been filed.  Upon request, NMA has previously not disclosed the name of the medicinal product nor the applicant until the marketing authorisation had been granted. From 1st August 2012, NMA will disclose such information after the procedure has ended.

Before the procedure has ended, NMA has announced that the following information may be disclosed upon request.

-The active ingredient

- The therapeutic class (ATC – second level)

- Date of submission of application

- Legal basis for the application

- Procedure for the application

The invented name, the name of the applicant, the Reference Member State (RMS) or Concerned Member States (CMS) will not be disclosed prior to the end of the procedure. Such information may however be disclosed after the procedure has ended, along with the public assessment report (PAR), the package leaflet and the summary of product characteristics (SmPC).

NMA has also announced that since EMA discloses information for applications that are rejected, suspended or withdrawn after a Commission decision, the same practice can be expected by the NMA.

The change in practice will apply for applications via mutual recognition procedure (MRP), decentralized procedure (DCP) and national procedure.

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For more information please visit www.grette.no

Grette

 

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