The marketing authorisation may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by the competent authority. Once renewed, the marketing authorisation shall be valid for an unlimited period unless the competent authority decides, on justified grounds relating to pharmacovigilance, to proceed with one additional five-year renewal.
The renewal dossier should contain a consolidated version of the file in respect of quality, safety and efficacy including all variations introduced since the marketing authorisation was granted or since the last renewal.
A renewal application shall be submitted to the NoMA at the latest nine months before the end of the five year period. The renewal application can also be submitted earlier than nine months after agreement with the NoMA. The request should be submitted to us by mail or e-mail to MT@legemiddelverket.no and should explain/include a justification to why the renewal application should be submitted in advance.
National procedure (NP)
The renewal of national marketing authorisations should be in accordance with the EU legislation. Please see the guidelines for human and veterinary medicinal products regarding required documentation and application form.
You will not receive approved product information (SmPC and PIL) for national renewals, unless one of the following categories applies to you:
- your medicinal product has not earlier had an approved PIL
- veterinary products that earlier only have had SmPC in the format of the Felleskatalogen
For these exceptions approved PIL and SmPC/PIL, respectively, will be forwarded to you.
Thus, if not covered by the exeptions mentioned above. the renewal date in the SmPC (p 9) may be implemented by the next update of the SmPC.Other updates of the SmPC, not covered by the exeptions mentioned above, may be implemented by the next variation application for your product. Changes to the labeling/mock-ups must be submitted separately.
Mutual recognition- (MRP) and decentralised procedure (DCP)
Medicinal products approved via the DCP and the MRP follow the MRP renewal procedure.
Please see the guidelines for human and veterinary medicinal products regarding required documentation and application form.
Submission of the Norwegian product information after the end of procedure in MRP
In case of changes to the common product information, please submit updated Norwegian product information (SmPC, PL and labelling as Word-files with “tracked-changes”). This can be done by replying to the automatic e-mail sent by the NoMA. If there are changes in design or layout of the mock-ups, please submit these as PDF-files. Note that mock-ups must be in line with the current guidelines and that NoMA may request updated mock-ups when needed. Mock-ups and Norwegian labelling text shall be submitted if there are changes in common labelling and design.
The renewal can be granted without the Norwegian product information, if the product is initially approved without the Norwegian product information.
Centralised procedure (CP)
Please see the guidelines for human and veterinary medicinal products regarding required documentation and application form below.