With the application of the EU Clinical Trials Regulation No 536/2014 (CTR) some labelling requirements for investigational medicinal products (IMP’s) have changed. According to these new requirements, the expiry date must be included on both the primary and secondary packaging of these products, without exception. Now, the proposed Commission Delegated Regulation amending the CTR as regards labelling requirements for unauthorized investigational (IMPs) and unauthorized auxiliary medicinal products (AxMPs) (Unauthorised medicinal products used in clinical trials (labelling rules)) 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 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 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 draft Delegated Regulation and its Annex can be downloaded from the Commission’s website, where comments are also available. The draft is open for comments until 29th of June 2022.