Renewal of marketing authorisations
Published:
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Updated:
Changes
- : Updated information regarding renewal of nationally approved products.
- : Changed information regarding mock-ups and labelling text
A marketing authorisation is generally valid for five years.
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.
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@dmp.no and should explain/include a justification to why the renewal application should be submitted in advance.
More information about each procedure
National procedure
The renewal of national marketing authorisations should be in accordance with the EU legislation. NOMA processes renewals for nationally authorised products according to CMDh's Best Practice Guide on the processing of renewals in the MRP/DCP.
Approved product information (SmPC and PL) will not be issued after finalisation of a national renewal. The renewal date in the SmPC section 9 should be implemented with the next update of the SmPC.
Decentralised Procedure (DCP) and Mutual Recognition Procedure (MRP)
Medicinal products approved via the decentralised procedure (DCP) and the mutual recognition procedure (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 significant 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. Norwegian labelling text shall be submitted if there are changes in common labelling.
The renewal can be granted without the Norwegian product information, if the product is initially approved without the Norwegian product information.
Further information:
Centralised procedure
Please see the guidelines for human and veterinary medicinal products regarding required documentation and application form below.