6. When, if an anti-tampering device (ATD) is implemented, is it necessary to submit a mock-up?

In case the ATD is located on the outer packaging, or located on the immediate packaging (because no outer packaging exists) and the package closing system is not affected, but the addition of the ATD will influence the readability of the packaging (change of font size, large shifts of texts, etc.), it is necessary for the marketing authorisation holder to submit the respective mock-up within the scope of a separate “P” type variation.

In case the ATD is to be located on the immediate packaging, because no outer packaging exists, and, concurrently, the ATD affects the package closing system, it is necessary for the marketing authorisation holder to mention this information in Module 3 (section 3.2.P.2.4 and/or 3.2.P.7). The introduction of an ATD on the immediate packaging where the packaging closing system is, concurrently, affected, shall require a submission of a B.II.e variation to marketing authorisation - a classification guideline refers. Should the ATD affect the readability of the packaging, the variation to marketing authorisation shall include also the submission of the relevant mock-up.