National Procedure for Marketing Authorisation

Request for timeslot for submission of application  

As soon as the applicant has estimated an intended submission date of the application (quarter or alternatively month, year), the applicant fills out the form "Request for time-slot for national marketing authorisation application” and sends the completed form to MT@dmp.no. The Norwegian Medical Products Agency (NOMA) will reply to the applicant as soon as possible and normally within three weeks upon receipt of the request.

The applicant must expect delayed validation and start of procedure if submission date has not been agreed on beforehand.

Receipt of application, validation and regulatory fees

NOMA verifies that the application fulfils the requirements to enable start of the procedure.  If the submission date has been agreed upon in advance, the applicant will normally receive a validation letter 2 weeks after  NOMA has received the application.

In some cases, other procedures are mandatory.  In the validation phase, NOMA checks that criteria for using the national procedure is met.

NOMA sends an invoice to the applicant after receiving the application.  Information on valid regulatory fees are published on NOMA`s website.  

Timetable- from procedure start to end of procedure

General information

Within 210 calendar days after the submission of a valid application, NOMA shall either approve the medicinal product or notify the applicant that the applicant that the application will be rejected. Time used by the applicant to prepare their responses to the questions from NOMA, is not counted. The procedure will be closed before day 210 if there are no outstanding issues.

Guidelines published on the websites of CMDh and CMDv are used as far as they are applicable for national marketing authorisation (MA) applications.

Accelerated procedure may, in exceptional cases, be considered if the applicant submits a substantiate request to NOMA. This is only applicable if the medicinal product is listed on NOMA`s announcement of medicinal products needed in Norway, in a shortage situation, or to meet an unmet medical need. In the accelerated procedure, NOMA sends the first assessment report to the applicant on day 70, the second report on day 125, and the third report on day 155.  The end of procedure is by day 175.

Assessment, round 1

• Day 0: NOMA starts the procedure.
• Day 105: NOMA sends the Assessment Report and product information with comments to the applicant.
• Clock- stop: Deadline for responding to questions is 3 months. The applicant may request an extension of the response deadline to 6 months. Requests for an extended deadline must be sent to NOMA sufficiently in advance of the specified deadline.   

Assessment, round 2

• Day 106: NOMA restarts the procedure after complete responses are received.  
• Dag 160: NOMA sends the Second Assessment Report and product information with comments to the applicant.
• Clock -stop: If any outstanding issue, the applicant is given 1 month to respond.  The applicant may request an extension of the response deadline to 2 months. Requests for an extended deadline must be sent to NOMA sufficiently in advance of the specified deadline.   

Assessment, round 3

• Day 161: NOMA restarts the procedure after complete response are received.
• Day 190. NOMA sends the Third Assessment Report and product information with comments to the applicant.  If any outstanding issue, there are two outcomes:
• The NOMA informs the applicant that the application will be rejected, and the applicant is given the opportunity to withdraw the application.   
• The applicant is given a short deadline to respond to minor outstanding issues. These issues must be resolved quickly. It is not possible to request an additional round with an extended response deadline.
• Day 210 End of procedure:
• Negative outcome:  If the applicant has not withdrawn the application within the deadline, the applicant will receive a rejection letter.  
• Positive outcome: The applicant will receive an approval letter.

After End of procedure- positive outcome

The marketing authorisation (MA letter) will be issued only when DMP has given final approval of the summary of product characteristics, package leaflet, labelling text in Word format, and mock-ups of the labelling.