Zero day procedure

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.


Apply for a zero day procedure

Instructions

When a zero-day procedure is approved by the IMA, the applicant must subsequently submit the following documents:


  • A cover letter clearly stating that the application is being submitted as a Day Zero procedure and the submitted dossier is identical to the approved dossier in the RMS
  • Consolidated dossier, preferably in eCTD format
  • Currently approved common PI
  • Application form (eAF)


Icelandic translation of the product information can be submitted after the end of the procedure together with the mock-ups, but before placing the product on the market.