The zero day procedure is one of the means available for marketing authorisation holders to increase the number of important medicinal products on the Icelandic market and thereby reduce shortages. A zero day procedure means that the Icleandic Medicines Agency (IMA) will approve application documents as approved by the relevant DCP/MRP or prospective RMS (MRP on the basis of a national marketing authorisation) without any comments. The same applies to the SmPC, package leaflet and labelling. When the medicinal product is on the market in the country that becomes RMS it already meets the conditions for quality, safety and efficacy and the IMA therefore approves the assessments made by the relevant RMS. A prerequisite for the IMA‘s approval for a zero day procedure is that the medicinal product will be marketed in Iceland as a result.
Marketing authorisation holders/agents must complete a request for a zero day procedure. IMA subsequently assesses the need for the medicinal product and suitability for a zero day procedure and informs the applicant of the decision. The decision of the IMA will generally be made 30 after a request has been submitted. For medicines with a proposed OTC legal status, the national phase begins after the OTC decision has been made by the IMA. The OTC assessment can take 45 days.
The Icelandic Medicines Agency may choose to reject a request for a zero-day procedure. In such cases, the company can always apply for a marketing authorisation using traditional MRP/repeat-use procedure.
Detailed information on zero day procedures
1. As Iceland agrees as new CMS via zero day procedure, Iceland also agrees that:
- No assessment reports are needed unless requested in exceptional cases and IMA already agrees the reports from the RMS without comments.
- No comments will be sent by IS and the procedure can be approved immediately upon day 0.
- IS agrees to fall into the current renewal cycle and PSUR submission timelines of the RMS.
- In addition the RMS should inform IS about current state of the dossier as if any ongoing variations or upcoming along with renewal status.
2. Once a Zero day application is submitted the following documents should be included:
- Cover letter stating that a zero day procedure is enclosed and the enclosed documents are already approved by the RMS
- eAF – without annexes except annexed documents listed according to the published MRP CMS validation check list which IMA will follow to validate the application
- Current dossier (consolidated dossier eCTD) preferably with all approved variations and confirmation of variation approvals.
- Current approved PI by the RMS (word and in eCTD)
3. The process of a zero day application
- IMA takes regular D-14 validation phase once application is submitted
- Once the application is valid by new CMS IS the RMS set Day 0 then IMA confirm no comments at day 30 (at day 0) and the procedure is closed (EoP) on day 0.
- The RMS submits a EoP letter/e-mail.
- A regular 30 days national phase starts after EoP
- Icelandic translations of the product information can be submitted after the End of Procedure together with the mock-ups, but before placing the product on the market.
- For products with proposed OTC status the national phase will not start until IMA decision on an OTC status is published. An OTC asssessment takes up to 45 days.