Labeling Requirements for IMPs Amended

Recommendation

12-14 December 2023

Stability by Design - Live Online Training
- Stability Testing in Product Design and Method Development- Focus mainly on small-molecule APIs and drug products

Following a 1-month feedback period on the draft published in June this year the European Commission (EC) finally adopted on 6 September the revised Annex VI to Regulation (EU) No 536/2014 (Clinical Trials Regulation, CTR) as regards labelling requirements for IMPs. The Regulation will enter into force on the twentieth day following its publication in the Official Journal of the European Union and will be binding and directly applicable in all Member States.

Background

The Commission Delegated Regulation amending the CTR as regards labelling requirements for unauthorized investigational (IMPs) and unauthorized auxiliary medicinal products (AxMPs) eliminates the obligation to include an expiry date on the primary packaging of IMPs / AxMPs in specific circumstances.

Feedback received from business organizations and companies on the draft delegated regulation, supported in majority the proposed rules. Some of these contributors proposed additional labelling exemptions, which were not considered due to the potential safety impact on clinical trial participants. Contributions were also received from citizens, who expressed their concerns. These concerns were mainly due to misunderstandings about the proposed rules, which were often understood as exemptions to label the expiry date for medicines or allowing unauthorized medicines to be put on the market. As a consequence, the draft Regulation was not amended after consultation.

The final Delegated Regulation and its Annex can be downloaded from the Commission's website, where the comments (including comments from EQPA's IMP Working Group) are also available. 

More information is provided under Unauthorised medicinal products used in clinical trials (labelling rules).