NHP Time is Running Out

Regular communication with the NHP Directorate over many years has enabled MCS to anticipate issues and opportunities for our clients’ submissions. This may translate into fewer delays on the road to NHP Registrations.

The most important things you can do to shorten approval times are:

  • Determine the correct type of submission required
  • Ensure full completion of the Product Licensing Application

Since it was established in January 2004, a large volume of submissions have been filed to the NHP Directorate. Many clients have asked how to “expedite the review process”. There is no fast track process, therefore, “Doing it right the first time” remains your best strategy for getting through the process as soon as possible.

Why delay? Contact us TODAY

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The NHPD issued an important notice on April 25th 2006, related to the backlog of over 10,000 product license applications (PLAs) for the NHP’s .

Performance standards and backlog elimination measures were put in place to address this backlog.

The NHPD is aiming to acknowledge all PLA’s within 3 days of receipt.

For example:
Only process complete applications will now be accepted by the NHPD. Incomplete applications will be refused entry to the “level one” processing queue and removed from the “level two” processing queue, and returned to the applicant.
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