New guidelines concerning publication of information in the Drug Catalogue and Price list.
A new form has been published.
The form „Guidelines concerning publication of information in the Drug Catalogue and the Price list“ has been updated. From now on this form shall be used when the marketing authorisation holder (MAH) applies for POM to OTC switch, which refers to the transfer of proven prescription only medication (POM) to nonprescription, over-the-counter (OTC) status.
The MAH can apply for this change when mock-ups of the outer packaging and patient information leaflet (PIL) are ready and available to consumers.
The Icelandic Medicines Agency (IMA) requests the form to be submitted at least one month before the new OTC package is introduced on the market.
The IMA wishes to remind MAHs that they might have to recall packages already available on the market if they do not fulfill the requirements of OTC sale, in which case cooperation with the IMA would be needed.