Companies that sell medicines on the Danish market are obliged to make the newest package leaflet available at the Danish package leaflet website indlaegsseddel.dk.
This way, patients and staff who handle medicines as part of their profession always have access to the latest revised product information.
The obligation to upload package leaflets to indlaegsseddel.dk has been in force since 1 January 2009. Please see the Danish Executive order no. 426 of 6 May 2011 on submission of package leaflets, which you can download in Danish via the link in the box to the right.
All 5,300 marketed medicines have been checked
To ensure compliance with the rules, the former Danish Medicines Agency (now the Danish National Board of Health) has checked if all medicines sold in Denmark have a corresponding package leaflet on the website indlaegsseddel.dk. The control process began in March 2010.
There are about 5,300 different medicines on the Danish market, and for all of them, we have checked the extent to which
- a package leaflet is available on indlaegsseddel.dk
- the package leaflet is easy to read
- the package leaflet has a revision date.
It is important that the package leaflet includes a revision date because it allows consumers to check if the package leaflet uploaded to indlaegsseddel.dk is newer than the one that came with the package supplied by the pharmacy.
Changes were required in 431 cases
Of the approx. 5,300 marketed medicines, about 8 % (431) had deficiencies in relation to the statutory requirements. All these deficiencies have since been corrected:
- A total of 356 package leaflets were missing. The majority of them have since been uploaded, but some companies chose to accelerate deregistrations of medicines or single strengths instead.
- 40 package leaflets did not have a revision date. These dates have since been added.
- 21 package leaflets had poor legibility. Legibility has since been improved.
- 14 medicines had been uploaded a summary of product characteristics or package leaflet for a wrong strength or pharmaceutical form. The right package leaflets have since been uploaded.
The control process
During the control period, which ended in September 2011, we have been in contact with approx. 200 companies. We decided on a risk-based approach, which meant that small companies, including those manufacturing natural medicines and strong vitamins and minerals, were chosen first.
We then moved on to larger companies. It turned out that especially small companies had not applied for access to DKMAnet - Package Leaflets, the portal for uploading the package leaflets, or had not renewed their access, and therefore had not uploaded any package leaflets at all or had only uploaded some.
As an integral part of the medicine control activities, the Danish Medicines Agency, now the Danish National Board of Health, has continuous focus on the quality of the packaging's label and the content of the package leaflets - see previous announcements in the box to the right.
Quantitative control supports focus on quality
The Danish National Board of Health will now focus on the quality of package leaflets and perform random checks of the package leaflets supplied with medicine packages and the package leaflets on the website indlaegsseddel.dk.
We will also focus on checking that the regulatory safety updates related to a medicine are inserted in the package leaflet.
