Draft on Labeling Requirements for IMPs Published

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

With the application of the EU Clinical Trials Regulation No 536/2014 (CTR) some labelling requirements for IMPs have changed, in particular regarding the expiry date. According to these new requirements, the expiry date must be included on both the primary and secondary packaging of these products, without exception. Now, an initiative eliminates the obligation to include an expiry date on the primary packaging of IMPs in specific circumstances. The draft is open for comment until 29 June 2022.

EU draft Commission Delegated Regulation on labeling requirements for IMPs

The proposed 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 unauthorized medicinal products used in clinical trials in specific circumstances (e.g. on syringes).

The specific circumstances, where the period of use (expiry date or re-test date as applicable) can be omitted on the primary packaging, are the following:

• In cases where the primary and secondary packaging are intended to remain together,
• If the primary packaging takes the form of blister packs or small units such as ampoules. However, a secondary packaging shall be provided bearing a label with all particulars (including the expiry date) required by the CTR.

The aim is to prevent additional safety and quality risks associated with the re-labelling procedure and the need for more frequent re-supply, which may lead to delays in clinical trials.

The draft Delegated Regulation and its Annex can be downloaded from the Commission's website, where comments are also available. Feedback will be taken into account in finalizing this initiative.

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