Information on how to manage marketing status for Liechtenstein

If centralised products are not launched in Liechtenstein but imported from other countries (e.g. Switzerland), we don't have any launch dates. How can we manage this situation in IRIS ? Thank you 








 

Dear iris colleagues,&nbsp;<br> If centralised products are not launched in Liechtenstein but imported from other countries (e.g. Switzerland), we don't have any launch dates. How can we manage this situation in IRIS ?&nbsp;Thank you&nbsp;<br> &nbsp;

<span lang="EN-GB" style="font-size:9.0pt"><span style="font-family:&quot;Verdana&quot;,sans-serif">The marketing status that needs to be reported in IRIS corresponds to the “placing on the market” which is defined in Chapter 1 of volume 2A of the Notice to Applicants as the date of release into the distribution chain i.e. out of the direct control of the&nbsp;<a href="https://www.ema.europa.eu/en/glossary/marketing-authorisation-holder" style="color:#0563c1; text-decoration:underline" target="_blank" title="The company or other legal entity that has the authorisation to market a medicine in one, several or all European Union Member States."><span style="text-decoration:none"><span style="text-underline:none">Marketing Authorisation Holder</span></span></a>. If the product is released for the Swiss market and later on imported in Liechtenstein, it does not need to be reported, since there is no obligation to report Imports in the Marketing Status portal, regardless if the import activity is done by the MAH or by another entity. Parallel imports are under the remit of National Competent Authorities. If the product is released for the Liechtenstein market (not an import), then it needs to be reported in IRIS.&nbsp;</span></span>

If we are in the case above reported of product imported in Liechtenstein from other Countries, should we marked "never marketed" for the baseline submission? Thank you very much

That is correct. Since imports are not required to be reported, the correct status would be Never marketed. That means that the Sunset clause provision may apply if the product is not considered Marketed in the European Union for a period of 3 years.