New version of the Product Literature Standard

Posted: 21 December 2016 at 3:53 pm

Following consultation the Product Literature Standard (PLS) for mock-ups for an animal medicine licence has been updated.

Product Literature Standard for veterinary medicinal products

Product literature supplied in support of an application for a marketing authorisation to the Veterinary Medicines Directorate must be in accordance with the standard

Product literature includes:

  • the immediate packaging, e.g. vial
  • the outer packaging, e.g. carton
  • the package leaflet, if application

The product literature mock-ups must be presented as a flat artwork design in full colour.

There are no changes to the regulatory requirements for producing mock ups for approval.