Request for Norway as RMS in decentralised procedure
The Norwegian Medicines Agency participates in the decentralised procedure as reference member state (RMS). During the last few years we have received an increasing number of requests to act as RMS. We will accept to act as RMS for as many submissions as possible within the limitation of our resources. In order to better schedule expected applications and optimising the use of our resources, a new procedure for requesting time slots is introduced.
The Norwegian Medicines Agency (NoMA) will open for RMS requests 4 times a year. After each period we will consider the received requests and give our response to the applicant whether the request is accepted or not. The applicant is asked to send the request 6-9 months before planned submission, according to the following schedule:
| Request to be submitted |
Response from NoMA at the latest |
Application to be submitted |
| 1.-31. January |
15. February |
1. August – 30. September |
| 1.-30. April |
15. May |
1. October – 31. December |
| 1.-31. July |
15. August |
1. January – 31. March |
| 1.-31. October |
15. November |
1. April – 30. June |
- The request should be made by filling in the common request form, which can be found here.
- The request should be sent by e-mail only to PK[at]noma.no Please include the following text in the heading of the email: DCP RMS request.
- The enclosed form must contain all relevant details. The applicant is requested to consider number of Concerned Member States and how many duplicate applications, if any, will be included in the procedure.
Applicants who receive a confirmation for a time slot must be prepared to keep the submission deadline. Submissions not delivered within the allocated time slot will usually be rejected. Request to switch medicinal product will also usually be rejected.
NoMA will not operate with a waiting list. This means that applicants who are not allocated a time slot will have to send a new request.
NoMA gives priority to
-
Applications within NoMA’s areas of interest (Human medicines: antibiotics, antidiabetics, therapy areas within cancer treatment and the central nerve system (preferably treatment of pain), human vaccines).
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Indications and active substances which the Agency previously has assessed.
For Veterinary medicinal products we will consider the requests according to available resources.
Kontaktpersoner:
Ørjan Walderhaug, Scientific officer
Tlf: + 47 22 16 84 11
Section for Regulatory Affairs
Norwegian Medicines Agency
e-mail: orjan.walderhaug[at]noma.no
Sist gjennomgått: 09.11.2011
Første gang publisert: 14.02.2008