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Product Literature Standard

11 October 2011

This Standard is meant as a guide for both Applicants when they are creating mock-ups for submission to regulatory authorities, and regulatory authorities when they are assessing mock-ups. This reference is to be used as a joint document between the Veterinary Medicines Directorate (VMD) and the Irish Medicines Board (IMB) (hereafter referred to collectively as the competent authority).

The main body of this standard includes requirements and guidance that are common to both the VMD and the IMB. Separate Annexes have been created that deal with requirements that are specific to the individual competent authorities; Annex A deals with the requirements specific to the VMD and Annex B deals with the requirements that are specific to the IMB.

This Standard brings together existing requirements into one bespoke document for a convenient reference rather than setting new requirements for product literature.

This document has been agreed with the assessors of the VMD and the IMB as well being discussed with industry representatives.

Product Literature Standard

Date Printed: 19 April 2014

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