Version 11 of EU Q&As on Safety Features: Specific Questions on Stickers

Recommendation

18 June 2024
Barcelona, Spain

QP pre-course Session: Interpersonal and Soft Skills for the QP

As of 9th February 2019, many prescription medicines in Europe will only be marketable if they meet the required safety features.

The European Commission released version 11 of the questions and answers catalogue on safety features in September 2018.

In "Version 10 of EU Q&As on Safety Features: Specific Questions on Bundle Packaging" from 26 September 2018 you could already read about the specific questions around bundle packaging covered by this significant EU publication.

Compared to the previous version, the answers to a few questions are basically diverging from the answers first given. As already reported in "New Questions and Answers on Safety Features - EU Q&As Version 10 published!" this also affects the placing of safety features by means of stickers.

Question 2.21 gives a comprehensive view on the conditions when stickers may be used. This is an exception to the rule that the "unique identifier" - the 2D Data Matrix Code with the serial number - has to be printed directly on the outer packaging and correspondingly explicitly authorised.

Stickers must be placed under GMP conditions and the outer packaging on which the identifier is placed as a sticker has to meet all applicable labelling requirements. Moreover, the use of stickers is not acceptable when the readability of compulsory regulatory information is limited; the sticker can be easily removed  without damaging the packaging (please also see CEN 16679 on that topic); or the sticker with the identifier is  intended  to be placed on top of an existing sticker.

The following changes were incorporated to the previous version:

New Q&As: 5.8, 6.8 and 8.8
Revised Q&As: 1.23, 7.15, 8.4, 8.7

To find further details please see the complete document entitled "Safety Features for Medicinal Products for Human Use, Questsions and Answers, Version 11" from September 2018.