Information stating that a medicinal product does not have a package leaflet can also be uploaded to the package leaflet database

Updated 02 March 2016

If a medicinal product does not have a package leaflet, the company can upload information to the package leaflet database stating that the product is exempted from having a package leaflet. We believe that this information might be useful to consumers.

Companies may also upload the following Danish text to the package leaflet database to state that a specific medicinal product does not come with a package leaflet:

{name of medicinal product}

I henhold til §11 i den gældende bekendtgørelse om mærkning m.m af lægemidler* er der ikke udarbejdet en indlægsseddel for dette produkt.

{Company name and date of upload}

*I §11 i bekendtgørelse nr. 869 af 21. juli 2011 fremgår det, at:

"Indlægssedlen kan udelades, hvis lægemidlet er beregnet til udelukkende at skulle administreres af sundhedspersoner eller dyrlæger og hvis lægemidlet ikke er beregnet til langtidsvirkende effekt."

{name of medicinal product} in the above is replaced with the name of the medicinal product concerned.


The meaning of the Danish text is as follows:

{name of medicinal product} Pursuant to section 11 of the current executive order on the labelling etc. of medicinal products*, no package leaflet has been drawn up for this product.

{Company name and date of upload}*In section 11 of executive order no. 869 of 21 July 2011, it is written that:

“The package leaflet may be left out if the medicinal product is only intended for administration by healthcare professionals or veterinarians, and if the medicinal product is not intended to have a long-term effect.”

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