One of the options available to marketing authorisation holders to make it easier to increase the number of necessary medicines on the market, and thereby reduce or prevent medicine shortages, is the Zero Day Procedure. The Zero Day Procedure means that the Icelandic Medicines Agency (IMA) will accept the application dossier without comments as approved in the DCP/MRP concerned (Repeat use Procedure) or by the prospective RMS (MRP based on a national marketing authorisation).

The same applies to the product information texts (Summary of Product Characteristics, labelling and package leaflet). As the medicinal product is on the market in the country that will be the RMS and therefore meets the requirements for quality, safety and efficacy, IMA accepts the assessment carried out by the medicines agency concerned.

A prerequisite for IMA's acceptance of a medicinal product in the Zero Day Procedure is that the medicinal product will be placed on the market.

Request for the Zero Day Procedure

The marketing authorisation holder/local representative must complete a request for the Zero Day Procedure using a form on IMA's website. IMA reserves the right to assess, case by case, the circumstances and market need for medicinal products with regard to whether registration through the Zero Day Procedure is warranted.

The general criteria for acceptance are based on, among other things, whether the medicinal product or a comparable product is already in the unlicensed medicines system, whether the medicinal product can meet market needs, e.g. due to an imminent or current medicine shortage, or whether other circumstances in society call for such fast-track registration and marketing of the medicinal product. It should be noted that the same criteria as set out above form the basis of IMA's decision for all medicinal products, including tendered medicinal products.

IMA's decision will generally be available thirty days after the request for the Zero Day Procedure has been sent to IMA, and the applicant will be informed accordingly. If it is intended to refuse a request for the Zero Day Procedure, the applicant will be informed of this and given 14 days to submit objections.

For medicinal products with a proposed legal status as over-the-counter medicines, the national phase does not begin until IMA has reached a decision on over-the-counter status. The assessment of over-the-counter status begins at the end of the procedure (End of Procedure) as soon as the Icelandic texts have been received, and the assessment may take up to 60 days.

IMA may choose to refuse a request for the Zero Day Procedure. In such cases, the company can always apply for a marketing authorisation through the standard MRP.

More about the Zero Day Procedure

Once acceptance has been given

When IMA agrees that a medicinal product will be granted a marketing authorisation following a Zero Day Procedure where Iceland is the CMS, the following applies:

• All assessment reports available from the Reference Member State (RMS) are accepted by IMA without comments. Assessment reports do not need to be sent to IMA unless specifically requested.

• IMA makes no comments to the RMS so that approval can be given immediately.

• The renewal cycle and PSUR submission timelines of the RMS apply.

Documents to accompany the application

Documents that must accompany a Zero Day marketing authorisation application to IMA:

• A cover letter clearly stating that the application is a Zero Day application and that the accompanying dossier is identical to the one already approved in the RMS.

• The dossier, preferably in consolidated eCTD format, containing all approved changes and confirmation of the change history/approval.

• The current product information (PI) approved by the RMS

• The application form (eAF) without annexes, except those specified in the CMS validation checklist in MRP.

The procedure

• When the application is received, a validation period of 14 days begins. Validation follows the CMS validation checklist in MRP.

• When the application is valid, the RMS sets day zero (start).

• Zero Day applications are approved (End of Procedure) on the same day (day zero) by the RMS once IMA has completed validation.

• The RMS sends the "End of Procedure" documents to IMA.

• The standard 30-day national phase begins.

• The current product information texts may be submitted after the "End of Procedure" together with mock-ups, but this must be done before the medicinal product is placed on the market.

• For medicinal products with a proposed legal status as over-the-counter medicines, the national phase does not begin until IMA has reached a decision on over-the-counter status. The over-the-counter assessment may take 60 days.

Fee for the Zero Day Procedure

The fee for a marketing authorisation following a Zero Day Procedure is charged in accordance with item 2.17 of IMA's tariff of fees.

Attention is also drawn to the rules on fee reductions (only available in Icelandic) including the fee for the Zero Day Procedure.