Guidance

Product literature mock-ups for an animal medicine licence

The product literature standard (PLS) to be applied when designing mock-up labelling and product literature for assessment.

Documents

Product Literature Standard

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Details

Product literature (mock-ups) supplied in support of an application for a marketing authorisation to the Veterinary Medicines Directorate must be in accordance with the Product Literature Standard.

Mock-ups includes:

  • the immediate packaging, eg vial
  • the outer packaging, eg carton
  • the package leaflet, if applicable

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

What is assessed?

Mock-ups are assessed against:

  • the agreed Quality Review of Documents (QRD) text and the agreed Summary of Product Characteristics (SPC)
  • the PLS
  • any other information provided by or discussed with you.

Mock-ups submitted should not deviate from the agreed QRD text and / or SPC.

In exceptional cases, you may be allowed to deviate from the above, but you must contact the relevant authority to discuss this before submitting your mock-ups. Not doing so will delay the approval of your mock-ups, which will then delay issue of the application.

The following are not assessed and should not be submitted with applications:

  • shipping packs
  • datasheets, including Material Safety DATA Sheets (MSDSs)
  • packaging for wholesalers that do not include any labels
  • display packaging
  • promotional material
  • dispensing envelopes are not required. However, if submitted to the VMD with the authorised packaging, they are considered to form part of the authorised packaging and will be subject to assessment.

Timescales

Mock-ups will be assessed within 20 days of receipt of correct versions.

Assessment Process

If only minor amendments to existing approved mock-ups are needed we will annotate your existing approved mock-ups, otherwise new mock-ups will be requested. You will be notified of this within 4 days of the procedure ending.

If the mock-ups contain errors, or are not suitable, you will receive a comments document listing any proposed changes. You should update the mock-ups to incorporate the proposed changes and return revised versions as soon as possible.

You will only receive 1 comments document. If the revised mock ups are still incorrect a condition will be applied to the authorisation to introduce corrected mock ups under the cover of a suitable national variation prior to marketing.

For joint labelled products, the United Kingdom (UK) and Ireland (IE) will agree any commentss before sending them to you. Further information about joint labelling is available from VMD and HPRA (IE).

No mock-ups

If you do not want to submit mock-ups (for certain pack sizes), or mock-ups are not submitted within the deadlines set, your application will be issued with a condition that mock-ups will need to be submitted for assessment under cover of a national C.II.6(b) Type IB variation category, prior to marketing.

Mock-up changes that require a variation

Any changes not already covered by a specific variation classification that may affect the legibility of the mock-up must be approved by way of a a national C.II.6(b) Type IB variation, for example:

  • new corporate design of packaging
  • new container type / size
  • changes to the layout of the package
  • introduction of multilingual packs for an already approved authorised product
  • introduction of mock-ups for an authorised pack size

You should only submit the mock ups for the packaging/labelling that is affected.

Notifications

Minor mock-up changes that do not affect the font size, layout or legibility do not require a variation, for example a change to the barcode, logo (assuming same size) change of IE national specific text.

If you are in doubt about whether a variation is needed, please contact notification@vmd.defra.gsi.gov.uk or vetinfo@hpra.ie

If the VMD/HPRA agrees that no variation is required, we will confirm this with you and make a note of the changes in our records. This does not mean the VMD/HPRA has assessed or approved the described change(s) only that they can be made without the need for a variation. You are not required to submit revised mock-ups to the VMD/HPRA but they can help to clairfy the change.

Published 26 November 2014
Last updated 25 January 2018 + show all updates
  1. Guidance reviewed and includes changes to data submission requirements for mock up assessment.
  2. Guidance updated
  3. Revised PLS
  4. First published.