Labelling of unit-dose blisters (single dose blister)

In section 19 of guideline no. 9368 of 25 May 2018 to the executive order on labelling etc. of medicinal products, the Danish Medicines Agency specifies the applicable requirements for the labelling of unit-dose blisters. We have received several questions regarding the labelling of unit-dose blisters, and below we would like to answer these questions to describe the requirements applicable in this area.

Discussions are ongoing in the EU about the labelling of unit-dose blisters, and we have to point out that Denmark will follow any future recommendations from the EU in this area so this may lead to a change of practice.

Question 1: What is a perforated blister (unit-dose blister)?

Answer: A blister that is perforated to facilitate single tablet administration.

Question 2: Which information should be provided on the perforated blister?

Answer: Each single blister must be labelled in accordance with section 19 of the executive order no. 869 of 21 July 2011 on labelling etc. of medicinal products. This means that the following information must appear from each single unit-dose:

1. The name of the medicinal product
2. The strength of the medicinal product
3. The pharmaceutical form
4. The name of the marketing authorisation holder
5. Batch number*
6. Expiry date*

* It is sufficient to indicate the batch number and expiry date only once on the blister. However, it is recommended to indicate the expiry date and batch number on each single unit-dose, as the user may keep single unit-dose blisters/parts of the blister in different places.

Question 3: Pursuant to section 19(1)(iv) of the executive order no. 869, the name of the marketing authorisation holder must be stated on each blister. Does this also apply if the name of the medicinal product is a generic name followed by the name of the marketing authorisation holder?

Answer: In current practice, it is sufficient to indicate the name of the marketing authorisation holder as part of the name of the medicinal product.

Question 4: Does section 2.2.3.1 of the application form (e.g. 21 x 1 or 21) or information about perforation of the blister in Module 3 decide whether it is a unit-dose blister?

Answer: It is solely the form of the blister that determines whether it is a unit-dose blister.

Question 5: If a label is affixed to the blister so that the perforation can no longer be used, should each unit-dose blister still be labelled?

Answer: No. If a label is affixed to the blister so that the perforation can no longer be used, the blister is no longer considered a unit-dose blister. Current practice is that labelling in such cases should only be stated once on the blister and must be in accordance with section 19 of the executive order on the labelling etc. of medicinal products.

Question 6: What is the DKMA’s definition of a blister affixed with a label so that the perforation can no longer be used?

Answer: A label affixed to the blister in a way so that the user is not encouraged to use any perforation, for example if the label covers the entire back of the blister. To facilitate use of the medicinal product if the label covers the entire back of the blister, we recommend a perforation around each blisterpocket.