Safety Features on the Packaging of Authorised Medicinal Products vs. Clinical Trials on Pharmaceuticals

In what form is it necessary to place safety features on the packaging of a medicinal product used within the scope of a clinical trial?

The requirements for the placement of safety features on the packaging do not apply to investigational medicinal products. Yet in case a medicinal product authorised in the Czech Republic is used in a clinical trial, safety features may be placed on the packaging. In this case, a label/sticker authorised for the clinical trial shall be used for the authorised medicinal product bearing safety features on the packaging; this label/sticker shall not – even partially – cover the unique identifier (UI).

The removal of the unique identifier from the repository system shall be performed by the pharmacy upon the dispensing of this medicinal product (to the trial site or directly to the trial subject).

In case the UI would be partially covered, it is necessary to cover it entirely and the entity relabelling the medicinal product shall remove the UI from the repository system. In case an authorised medicinal product with safety features on the packaging is repackaged by the manufacturer, it shall be removed from the repository system by the entity performing the repackaging of the medicinal product; nevertheless, this entity shall not place any new safety features (UI or ATD) on the packaging. 

The procedure for the labelling of authorised medicinal products for the purposes of clinical trials is available from: Informace o změně sekundárního obalu léčivého přípravku – SÚKL (gov.cz)

May 2, 2019

Department of Clinical Trials on Pharmaceuticals