Version 10 of EU Q&As on Safety Features: Specific Questions on Bundle Packaging

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.

In "New Questions and Answers on Safety Features - EU Q&As Version 10 published!" from earlier this September you could read about this important EU publication. Now, a significant aspect of this document is bundle packaging.

Compared to the previous version, the answers to a few questions are basically diverging from the answers first given - for example, the answer to question 1.19 regarding bundle packaging. As in the previous version it is specified that depending on the marketing authorisation the safety features have to be placed on the outer packaging: either on each single pack or on the bundle packaging itself. In contrast to the previous version yet, labels are also authorised.

However, in this case the label on the bundle must include all the necessary markings including the safety features.

Please also see the complete document entitled "Safety Features for Medicinal Products for Human Use, Questsions and Answers, Version 10" from July 2018 for further information.