Pre-submission meetings provide an opportunity for advice and guidance prior to submission of a medicines dossier, as well as an opportunity for the applicant to meet the PQT medicines (PQTm) assessment team that will be involved with the assessment of their product.
Pre-submission meetings can be especially helpful to applicants that have limited experience with PQTm, and are compulsory for all new applicants to PQTm. However, pre-submission meetings are also useful for applicants experienced with PQTm, to address issues specific to their intended dossier.
A pre-submission meeting allows the PQT medicines team to review an overview of the product and
a) ensure that the applicant is on the right track,
b) provide general guidance on how to proceed, and
c) provide guidance on identified issues that should be dealt with prior to submission.
At the same time, it is an opportunity for the applicant to,
a) introduce and discuss the intended dossier,
b) raise questions and gain valuable feedback and
c) address issues prior to submission.
The pre-submission meeting should enable an applicant to submit a medicines dossier that can proceed more quickly through the screening and subsequent stages of assessment.
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