5.6 Investigational product

The sponsor is responsible for supplying the investigational pharmaceutical product(s) and, if applicable, comparator products, prepared in accordance with principles of Good Manufacturing Practice (GMP) (see also Section 10). The product(s) should be fully characterized, properly coded, and suitably packaged in such a way as to provide protection against deterioration and safeguard blinding procedures (if applicable); appropriate investigational labelling should be affixed.

Sufficient samples of each batch and a record of analyses and characteristics must be kept for reference so that, if necessary, an independent laboratory is able to re-check the investigational product(s), e.g. for quality control or bioequivalence.

Records of the quantities of investigational pharmaceutical products supplied must be maintained with batch or serial numbers. The sponsor must ensure that the investigator is able to establish a system within his or her institution for adequate and safe handling, storage, use, return (to the investigator or sponsor) and, if appropriate, destruction of the investigational product(s).