GovWire

Introduction

The Product Literature Standard (PLS) should be taken into account when creating mock-ups for assessment.

Taking note of the following will greatly enhance your chances of getting your mock-ups right first time:

• Follow the approved QRD text (if available) or the approved SPC (if no QRD) and information in this document
• If you wish to deviate from the above, contact the relevant authority before submitting mock-ups
• Deviating from the above will only be permitted in very exceptional circumstances it is up to you to agree the wording during the assessment phase of the application procedure and / or before the mock-up review process
• Minor deviations are permitted to correct grammatical errors.
• If you are asked to make changes, please make them and do not make any other changes without agreeing it with the relevant authority first.

Joint labelling with Ireland

Joint labelling could be achieved between GB and IE, NI and IE or all 3 - GB, IE and NI. You can apply either at the end of a new MA procedure or retrospectively for existing MAs, whether authorised by EU or national procedures.

To obtain joint labelling, the SPC/QRD must be identical in both the UK and IE. This can be achieved by applying for a harmonisation variation in both countries. To maintain joint labelling the SPC/QRD must remain harmonised.

Please also see further guidance on acceptable additional information permissible on the labelling and package leaflet of veterinary medicines jointly labelled for the UK and Irish market (PDF, 212 KB, 8 pages).

See Joint labelling for veterinary medicines for use in the UK and Ireland.

Definitions

Templates

You must provide draft QRD text using the appropriate template. For initial GB or NI-national only Marketing Authorisations (MAs) validated on or after 28 January 2022, you must use therevised national SPC/QRD template (MS Word Document, 51.7 KB). An annotated version of this template (PDF, 391 KB, 32 pages) is available which provides supporting guidance on the information requirements listed.

For national MAs granted or validated before 28 January 2022, you may continue to use the original national template (MS Word Document, 58.9 KB).

For mutually recognised MAs you must use the template provided in the Best Practice Guides.

See Summary of Product Characteristics and product literature for veterinary medicines for more information on the application process relating to mock-ups in the UK.

Before you create mock-ups

The amount of space you have available on packaging should be considered from the outset and throughout the assessment process. The amount of text included on the QRD must reflect the size of the label.

If you are concerned about fitting the agreed text onto your packaging you must discuss this with the relevant assessor during the assessment phase before the QRD text is agreed.

Designing mock-ups

The following should be taken into consideration during the design of mock-ups.

Font type and size:

• font type should be easy to read and not overly stylised, which can be difficult to read
• choose a font that clearly distinguishes between similar characters such as i, l and 1
• capitals should be avoided but can be used to emphasise words
• Italics should be used for Latin terms when citing correct nomenclature and microorganisms
• font size should be as large as possible and must be clearly legible to the user. Font size should be measured against Times New Roman. If you cant use the recommended font sizes list below, please include a justification for this when submitting mock-ups

*only in exceptional circumstances and on a case-by-case basis.

Colour

• colours should have a good contrast between the text and the background
• legibility of information should not be compromised by the colours chosen. Preferably, dark text should be printed on a light background, but the reverse may also be applied in certain circumstances, such as to highlight a particular warning

Design and Layout

• legibility of information should not be compromised by design. Consider, whether the layout, font size and legibility has been fully optimised
• where possible line spaces should be kept clear which enhances clarity
• column text formatting is acceptable but the margin between columns should be large enough to separate the text clearly
• if space is limited a vertical line may be used to separate text. Related information should be kept together so that information flows from one column to the next

Headings

• bold type and different colour headings can help information stand out and users navigate the text
• spacing above and below the headings should be consistent throughout the packaging
• avoid using multiple headings as using more than two levels may cause confusion
• use of QRD headings on the immediate and outer packaging is not obligatory, but you must include headings that clearly convey meaning, such as withdrawal period

Use of Images and Symbols

• you can include clear diagrams and images in addition to wording, provided they are not misleading or cause confusion
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