The European Commission has published a draft template for the Qualified Person's (QP) declaration concerning GMP compliance of investigational medicinal products (IMPs) manufactured in non-EU countries. The template would be part of the dossier submitted with a request for authorisation of a clinical trial.
In this template, the QP should confirm that the IMP manufactured in a third country meets EU GMP standards for IMPs. This could be proved by either a personal on-site audit or an audit conducted by a third party or by another QP employed by the importer. If no audit has been performed, a brief justification and explanation should be provided, describing how the QP knows that standards at least equivalent to EU GMP are being followed at the site.
Stakeholders are invited to comment on this draft by 2 April 2013. Responses should be sent preferably by e-mail to email@example.com.