27-29 February 2024
The EU Commission has published the final Template for the qualified person's declaration equivalence to EU GMP for investigational medicinal products manufactured in third countries. It seems that they accepted some proposals made by stakeholders in their comments.
For example, Part B of the template has been revised. In the draft version, it was forseen that the QP states whether the audit was conducted personally or by someone else. Now the final version merely requires stating the details of the "auditing party" and the date when the manufacturing site was last audited. The reference that the QP declaration should be based on an audit conducted within the previous three years has been removed.
In cases where no site audit has been performed by or on behalf of the QP, it will be required that justification will be provided explaining how the QP knows that GMP standards are being followed at the site. This has been modified to allow QPs to make use of audits performed by national competent authorities and related GMP certificates. The revised template states that when providing a justification, QPs may refer to the assessment of documentation provided by the manufacturer, like e.g. valid GMP certificates.
It still will be required that the QP documents the manufacturing and/or importation authorization (MIA) number under which the declaration is being made. However, some Member States, like Germany, do not issue such ID numbers. The document has been revised accordingly, stating if no such number is issued, the QP should document the name of the authorization holder.
Source: Template for the qualified person's declaration equivalence to EU GMP for investigational medicinal products manufactured in third countries (SANCO/D/6/SF/mg/ddg1.d.6(2013)1104750).