New questions and answers about safety features - Version 7 of the EU Q&As published

Recommendation

18 June 2024
Barcelona, Spain

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

From February 9th, 2019 forward, many prescription drugs may only be placed on the European market if they bear the mandatory safety features.

The European Commission published Version 7 of the questions and answers about safety features in June 2017. Compared to the previous version, eight new questions and answers have been added; also, six questions and answers have been revised. In total, the document now contains 65 questions and answers about safety features.

Question 1.15 has been newly added, for example, about whether there would be financial support for the implementation of safety features by the EU (or national). This question was negated.

Also newly added was question 2.14 about whether the Delegated Regulation would set guidelines on how the safety features should be applied to the outer packaging. The answer states that the Delegated Regulations do not contain any specific guidelines about the placement of the safety features on the outer packaging. It is therefore up the individual pharmaceutical manufacturer how he wishes to implement the safety features.

Question 1.2 confirmed the ambitious schedule. All European states with the exception of Belgium, Greece and Italy must have the newly-mandatory safety features implemented by February 9th, 2019.

Please also read version 7 of the questions and answers of the EU Commission about safety features for further details.