As of 1 October 2012 the procedure to request Norway to act as RMS in DCP is changing: The request can be submitted at any time, however at least three months before the planned submission of the Marketing Authorisation Application (MAA). The Norwegian Medicines Agency (NoMA) will consider the request in relation to available resources and will reply to the applicant as soon as possible and normally within three weeks upon receipt of the request.
Use the common request form
The common request form should be used when submitting a request. The request should be sent to PK@noma.no and the heading of the e-mail should read: “DCP RMS request”. The form must contain all relevant details. Please fill in which Concerned Member States (CMS) will be included and how many duplicate applications, if any, will be submitted.
Meet the agreed timelines
When it is agreed that Norway will act as RMS, a fee of 50 000 NOK will be payable by the applicant to NoMA. The applicant should also meet the agreed submission timeline. If the timeline is not met, the submission will usually be rejected. The agreed submission timeline can be used for the agreed MAA only; switching the product for which the MAA is made is usually not possible.