Table 4 Legislation for non-investigational medicinal products

Although non-IMPs do not fall within the rules for manufacturing of investigational medicinal products, the EC does require the sponsor of a study to “ensure that the non-IMPs are in accordance with the notification/request for authorisation to conduct the trial and that they are of appropriate quality for the purposes of the trial taking into account the source of the materials, whether or not they are the subject of a marketing authorisation and whether they have been repackaged. The advice and involvement of a Qualified Person is recommended”.