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IP relabeling due to Sponsor's name change



  • Anna
    19/06/2020 11:39
    Dear colleagues, We have the following issue with IP in US. IP is now onsite, and Sponsor's name has been changed. The Sponsor created a completely new label. It is legal to place it as a booklet on the old one (not covering) to support traceability of data? In such a case, is it possible to relabel IP onsite or only relabeling at the warehouse is possible (due to QP sign of required)? Is FDA approval of new label required? Could we face problems with exporting relabeled IP out of US? Thank you very much for your answers.
  • GMP Committee response
    13/07/2020 17:46
    Without further information it is difficult to fully respond to this question. 1. “On site” could be understood to be at the clinical site. 2. “On site” could be understood to be at a GMP warehouse. 1. The most complex situation is labelling at the Clinical Site Firstly, the issue is not just an aspect of labelling. There are many other aspects of change of name that either need accepting or changing. E.g. Contracts, CRFs, Patient Information including Informed Consent etc. These are all impacted by the scope of the change – Ranging from an office address change through a company merger to the most extreme with the sale of the product / Intellectual Property from one company to another. Relabeling, and how this can be achieved most efficiently, should therefore be considered along with all of the above issues as part of a comprehensive Change review. The name and contact details (if not supplied by some other means) on the label are part of the overall change process for an ongoing clinical study. The overall process and timing will vary greatly depending on the circumstance. It is very common for existing labels to be used for a period without replacement. The length of that period being influenced by legal and practical aspects. 1 and 2, where IMP is both at the clinical site and in a warehouse not yet sent to Clinical Site. The first choice of relabeling would be to prepare new supplies or rework existing supplies in a manner to remove the old labeling and fully replace it in a controlled GMP environment appropriately contracted. Relabeling of this type at a clinical site would have high risk and critical GCP findings have occurred in the experience of the Committee when it has been attempted. It would not be acceptable in the EU unless the site itself possesses a MIA(IMP) and then the exercise would be subject to the same oversight as if it were executed at a warehouse, including QP certification. The point of QP (within the USA) is a confusing one. There would be no need for QP certification in the USA however, if the Sponsor is EU based, then the QP probably would be involved with the GMP contracting and release of the reworked IMP. FDA do not approve the labels. However, notification of Sponsor change for the IND would be a significant aspect of the change for the study outlined above. Exporting IP out of the USA is again confusing – If coming to the EU that would be a significant consideration. Import would be a QP related process as well as multiple regulatory considerations. It is highly unlikely that a QP would be able to certify IMP on import if it has been relabeled at a clinical site. This would be possible if relabeling is performed at a warehouse if the QP has full knowledge of what has taken place and can certify that the work was performed to EU-GMP or equivalent. This does also come back to the Change management of the wider impact of the sponsor change– to enable import the IMPD would have to be updated and a new QP declaration for a “Third country” site would be required
  • Anna
    13/07/2020 19:40
    Dear colleagues, Many thanks for your such a detailed reply, much appreciated.
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