Labelling shall be such as to ensure protection of the subject and traceability, to enable identification of
the product and trial, and to facilitate proper use of IMP.
Labelling of the containers should conform with the local regulatory requirements.
The labelling on each container should comprise at least the following information:
trial reference code;
trial subject identification number;
batch and/or code number to identify the contents and packaging operation;
period number;
pharmaceutical dosage form, route of administration, quantity of dosage units per container;
the identity of the product;
period of use (use-by date, expiry date or retest date as applicable), in month/year format and in
a manner that avoids any ambiguity;
storage conditions.
The note for guidance on the investigation of bioavailability and bioequivalence (CPMP/EWP
/QWP/1401/98) does not require bioavailability and bioequivalence trials to be conducted blinded.
