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.
IMA emphasizes that medicinal products that are assessed as suitable for a zero day procedure are primarily drugs that are necessary for the Icelandic market, that they reduce or prevent drug shortages and reduce the use of medicinal products in the so-called exemption system
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 days 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 applicant can always apply for a marketing authorisation using traditional MRP/repeat-use procedure.
Detailed information on zero day procedures
1. As Iceland accepts to act as CMS via zero day procedure, Iceland also agrees that:
- No assessment reports are needed unless requested in exceptional cases and IMA already accepts the reports from the RMS without comments.
- No comments will be submitted by IMA and the procedure can be approved immediately upon day 0.
- IMA agrees to follow the current renewal cycle and PSUR submission timelines of the RMS.
- In addition the RMS should inform IMA about current state of the dossier along with any ongoing or upcoming variations and renewal status.
2. Once a Zero day application is submitted the following documents should be included:
- A 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 will be used 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 formats)
3. The process of a zero day application
- The validation period is 14 days once the application is submitted
- Once the application is valid by new IMA the RMS sets Day 0.
- IMA confirms „no comments“ at day 30 (at day 0) and the procedure is closed (EoP) on day 0.
- The RMS submits an EoP letter/e-mail.
- A regular 30 days national phase starts after EoP
- Icelandic translations of the product information can be submitted after the EoP along with the mock-ups, but before placing the product on the market.
- For products with proposed OTC status the national phase will start when IMA‘s decision on the OTC status is published. An OTC asssessment takes up to 45 days.
Fee for a zero day procedure
Fee for a marketing authorisation following a zero day procedure is charged according to section 2.17 of IMA’s tariff schedule
Rules on fee reduction including fee for the zero day procedure are in a separate document.