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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

Definitions

Templates

You must provide draft QRD text using the appropriate template. For initial national Marketing Authorisations (MAs) validated on or after 29 April 2024, you must use the national product information template (MS Word Document, 85.7 KB). An annotated version of this template (PDF, 444 KB, 36 pages) is available which provides supporting guidance on the information requirements listed.

For national MAs granted or validated before 29 April 2024, you may continue to use prior versions of this template, available here:

• For MAs validated before 28 January 2022, theoriginal national product information template(MS Word Document,58.9 KB)
• For MAs validated after 28 January 2022 but before 29 April 2024, the v.1 (MS Word Document, 56.4 KB) or v.2 (MS Word Document, 52.9 KB) national product information template. V.1 was updated on 13 June 2023 to simplify requirements for the outer and immediate labelling
• For national MAs, you should update and implement the product information in line with the v.3 template by 1 April 2029.

For mutually recognised MAs where NI is Concerned Member State (CMS), guidance on QRD templates is available from the EMA website.

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
• symbols and images can be useful provided the meaning is clear and that the size of the image is legible

Shared labelling with other countries

Shared labelling are medicinal products that are labelled to allow their placing on the market in several countries with the same packaging.

Links to the Product Information Datab

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