In accordance with the “Guideline on the responsibilities of the sponsor with regard to handling and shipping of IMPs for human use in accordance with GCP and GMP,” investigational medicinal products (IMPs) cannot be used in a clinical trial in a member state of the European Union until the two-step process has been completed. The draft of the recommendation was released in 2018. The CTR was first put into use at the beginning of last year, and now the final version of the guideline has been made public. On January 1, 2023, the law became operative.

Release Procedure for IMP

The first step, as per the Template for IMP batch release, is the certification of each batch by the Qualified Person (QP) of the manufacturer or importer in accordance with the Clinical Trials Regulation (EU) No 536/2014 (CTR) to ensure that the CTR’s requirements as well as those outlined in Article 12 (Responsibilities of the QP) of the Commission Delegated Regulation (EU) No 1569/2017 have been met and documented.

The second phase is the regulatory release by the sponsor, which entails confirming that the batch certification by the QP has been completed and that the clinical study has the required authorizations before supplying IMP to the clinical trial site. Both procedures must to be documented and kept in the clinical trial master file (TMF). IMPs should be in control of the sponsor until the release procedure is finished.

Shipping of IMPs

The risk of exposure to circumstances that can compromise the product’s quality and integrity should be kept to a minimum throughout the delivery of the IMPs. This covers the product’s security, as well as making sure that the applicable GDP principles are taken into account, for example, regarding documentation, transportation (including choosing a container and packaging, engaging in qualification and/or validation activities, and keeping an eye on the conditions of the transport), and outsourced activities.



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