Pharmaceutical companies must ensure that the labelling on the medicine packages cannot disappear

When patients take medicine home, it is important that the text on the package does not fade or rub off when the patient have the package in their hands. The Danish Medicines Agency continuously tests whether the printed text meets the requirement that the labelling must be indelible. Find the Danish Medicines Agency's test method here. 

It is a requirement that the text on medicine packages must be indelible, because all information on the packaging, e.g. expiration date and batch number, shall always be readable. There are no standardised methods or guides on how to test the labelling on the packaging, but the Danish Medicines Agency has some clear expectations for the properties and quality of the packaging. Just as if the durability of the print's colours is to be assessed, the agency has a method for testing the risk of whether the labelling can be rubbed off the packaging.

When a printed colour on the packaging is to be assessed, it may be assessed with the Pantone Matching System. With the Pantone Matching System, you are able to assess if there has been a colour change, such as colour fading.

The packaging of the medicine is affected by, among other things, heat and oils from palm of your hand when the medicine is in use. The printed labelling must also be able to withstand this wear, e.g. containers with tablets must be able to be opened and closed tightly repeatedly without rubbing off the print. The test method takes this handling into account.

The Danish Medicines Agency's inspectors and laboratory control that the packaging of medicinal products complies with the requirements. Random sampling is carried out both by the laboratory and when the inspectors inspect the pharmaceutical companies.