IMA has published a new guideline on the Zero Day MRP/RUP process (in Icelandic).
IMA grants marketing authorisation through the Zero Day MRP/RUP process based on another RMS assessment without commenting. However, the applicant must ask IMA for permission to start the process, and for this purpose a separate electronic form (link found in the instruction) has also been published. A condition for the rather straightforward process is that the medicinal product will be marketed in Iceland. IMA assesses the need for the preparation and the suitability of the Zero day process upon receipt of the request and the evaluation will take approximately one month. If IMA rejects the zero day request, the applicant may continue to apply for marketing authorisation through the normal process.
For OTC products, the national stage will not start until IMA has processed the OTC classification, which can take about 45 days.
The documentation of the marketing authorisation application itself is recommended to be consolidated dossier, but if this is not available, the applicant will submit at least the following:
- A cover letter referring to the marketing authorisation dossier approved in the DCP/MRP. In addition, the applicant should commit that this will be submitted to the IMA if necessary. The cover letter shall mention the zero day procedure and the date on which IMA has accepted that a marketing authorisation may be applied through this procedure.
- Application form for marketing authorisation, with current data from DCP/MRP. However, the form attachments do not need to be provided.
- Common EN SmPC and Icelandic translation. EN labelling texts and leaflet. Translations of these can be delivered upon completion of the process. Mock-ups must be delivered before the product is marketed.