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TSE/BSE Statements



  • Ferenc Erdos
    10/04/2020 14:49
    I am working closely with drug packaging/labelling/distributor companies and the getting the TSE/BSE certificates for the medicinal products used in the trial is always a question. I was just wondering - and sorry for the maybe inappropriate question - if these certificates are issued and needed for all products or there is a way to find out (from IMPD, IB, SMPC maybe) if for a product this certificate is not applicable.
  • GMP Committee response
    10/06/2020 13:13
    There are two clear situations. 1. The product is fully the responsibility of the Study Sponsor and the TSE assessment by the QP is within section 2 of the IMPD. Access to the IMPD is all that is required. 2. Use of a commercial product from the EU market, then TSE requirements must have been met by the MAH prior to QP certification. The EMA ‘Guideline on the requirements for the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials’ (EMA/CHMP/QWP/545525/2017) allows “For test and comparator products to be used in clinical trials which have already been authorised in the EU/EEA or in one of the ICH-regions (and are sourced from these countries), it will be sufficient to provide the name of the MA-holder and the MA-number as proof for the existence of a MA, incl. copy of the SmPC/Summary of Product Characteristics or its equivalent e.g. Prescribing information” in lieu of detailed IMPD documentation. The less clear situation is the case of import of Unlicensed Medicinal Product where there is no EU consistent requirement however the expectation of review of adequate TSE certification would be expected.
  • Ferenc
    08/07/2020 20:43
    Thank you! These helped a lot already. I was also wondering if there are certain kind of products where TSE/BSE statement is not applicable due to the API and excipients. Sorry if this is a naive question, I just assume that for instance for a saline solution this is not applicable, as there is no way that this type of does it? Maybe this can help us for the NIMPs not authorised in EU.
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