Amendment to the CTR on IMP Labelling

As previously reported in the news entitled Labeling Requirements for IMPs Amended the European Commission (EC) revised the current labelling requirements provided in the Clinical Trials Regulation (CTR) for investigational medicinal products (IMPs) regarding expiry dates by means of a Delegated Regulation. Now the regulation has been published in the Official Journal of the European Union.

Background

The CTR applies as of January 31, 2022. This has been accompanied by a separation of the GMP requirements for IMPs from those for authorized medicinal products. In the case of products that have not yet been approved, the stability and shelf-life studies have often not been completed and new information regarding the expiry date of the IMP arises in the course of the development phase. This results in the need to subsequently re-label IMPs that have already been delivered and personalized for the patient with the new expiry date. The current regulations require labelling on both inner and outer packaging, so when a change is made, packages must also be opened to update the information on the inner packaging as well. Frequent updates of the expiry date on the primary packaging of unapproved drugs used in clinical trials may, in certain cases, pose potential risks to the quality and safety of these products (e.g., by the need to open the packaging, requiring tamper-evident seals to be broken and sets consisting of multiple layers to be disassembled or by prolonged exposure to light or higher temperatures for medicines that are sensitive in this regard).

The EU Commission therefore believes that in certain cases, given the nature and extent of the risk, it is appropriate and proportionate for the expiry date to be omitted from the immediate packaging. To implement this option in the CTR legislative framework, the EU Commission published an amendment to CTR with the Delegated Regulation 2022/2239. The regulation will enter into force 20 days after its publication in the Official Journal of the EU (published on 15. November 2022).