Expiry dating of investigational medicinal products


expiry dating of investigational medicinal products-68

The use of IVRS for expiry date handeling worries me if there is none on the box to double check against.

There was a large Pharma sponsored trial that has had a serious breach in the last few years due to the fact that the drug was allocated to a patient even though it would expire during the scheduled treatment for the patient.

In an effort to harmonize the clinical study drug supply labeling requirements, Chapter X of the Regulation provides rules for clinical labeling.

Further, to fill perceived gaps in individual member state requirements, annex VI was added to the regulation with additional detail about clinical labeling requirements. 536/2014 Annex VI defines the clinical labeling requirements for both investigational medicinal products (IMPs) and auxiliary medicinal products (AMPs) and the labeling requirements differ for each.

The most common query we receive relates to deciding if an activity should be considered as manufacture or reconstitution.