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QRD text for Nationally Authorised Veterinary Medicinal Products

The VMD would like to have agreed QRD (Quality Review of Documents) for all veterinary medicinal products.

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We would like to have agreed QRD text for all veterinary medicinal products which can then be maintained throughout the product’s life.

This will make it easier to agree changes to the wording on your packaging and remove the need for full colour mock ups to always be submitted.

To achieve this we ask that you submit QRD text for review against the latest authorised mock-ups by 31st July 2017; no fee will apply.

We will notify relevant Marketing Authorisation Holder’s (MAH) of any products that already have an approved National QRD held by us.

Submit your QRD text to s.response@vmd.defra.gsi.gov.uk, using the Submission of QRD text for nationally authorised MAs (MS Word Document, 49.5KB) form and the National QRD template.

We will not routinely require mock ups to be submitted. However, if we do not already hold electronic copies of your approved mock ups, we will request these.

We aim to issue the agreed version within 90 days of receipt. You do not have to update your mock ups to the latest QRD version.

Once your QRD text has been issued, a revised version should be submitted with all future applications that affect it. If an authorisation is due for renewal you can submit QRD text for approval as part of the renewal process.

If you wish to make changes to your QRD text or submit mock-ups for approval alongside the QRD text, you need to submit an application for a Type IB variation (C.II.6(b)) instead.

For further information email; notification@vmd.defra.gsi.gov.uk.

Published 25 August 2016