Instructions for the correct interpretation of the standard terms "blister" and "unit-dose blister"
This instruction is intended for applicants/marketing authorization holders as a guide for the correct interpretation of the standard terms "blister" and "unit dose blister", in accordance with the definitions available on the website of the European Directorate for the Quality of Medicines (EDQM) of the Council of Europe. The instruction was created with the aim of avoiding possible medication errors due to the separation of perforated blister units that do not contain all the necessary information as stated below.
Blister
Container (usually multidose) consisting of two layers of which one is shaped to contain the individual doses. Strips and unit-dose blisters are excluded.
Unit-dose blister
Container consisting of two layers of which one is shaped to contain the individual unit, usually provided with perforations, the intention being to allow each individual unit to be separated for single unit administration. All the information required for blister packs must appear on each unit dose presentation. Blisters and strips are excluded.
With regard to unit-dose blisters, in the application form, Summary of product characteristics, Package leaflet and on the outer packaging of the medicinal product, the package size should be stated as in the following example: "20 x 1 tablet". All information that should be contained in the inner packaging of the "blister" type (name of the medicinal product, active substance, marketing authorization holder, batch number and expiration date) should be located on each unit of the unit-dose blister, in accordance with point 9. of the Instructions for preparing a mock-up of the packaging of the medicinal product.
Blisters with perforations (perforated blisters) should be approved exclusively as unit-dose blisters, in accordance with the EDQM definition for the standard term "unit-dose blister".
In procedures for granting marketing authorisation and variation applications in which a new type of blister is introduced, it is necessary to submit a mock-up of the inner packaging of the medicinal product (Module 1.3.2). In case of unit-dose blisters perforations should be clearly indicated on the mock-up, while perforations are not acceptable in regular blisters.
