What essential content must be included on the label for a study drug in the EU?

In the context of labeling for study drugs in the EU, including the period of use is critical for ensuring proper usage and safety during the clinical trial. This information provides essential guidance for trial participants, allowing them to understand how long they can expect to take the medication and any relevant implications regarding its timing and usage. It supports compliance with the study protocol and helps maintain participants' safety by clarifying when they should take the drug and for how long.

It's important to note that while the other elements can be relevant in different contexts, the specific requirement for the period of use on the label stands out as a distinct regulatory expectation to avoid potential misuse. This ensures that participants have clear information about drug administration timelines, which is crucial for studies assessing the drug's efficacy and safety over defined periods.