Layout & Typography Advice

This applies to the information in the critical health information panel.

Labelling must contain all elements required by Article 54 of Council Directive 2001/83/EEC.

Article 56 of Council Directive 2001/83/EEC states that the particulars referred to in Articles 54, 55 and 62 shall be easily legible, clearly comprehensible and indelible.

This Code of Practice should be read alongside the legislative requirements as set out in Council Directive 2001/83/EC, Article 54. It is a legal requirement for companies to submit full colour actual size mock-ups of packaging to the MHRA as part of an application for a Marketing Authorisation, a variation to an existing Marketing Authorisation which affects the information on the label or an application or notification submitted under Article 61(3) of Council Directive 2001/83/EC to propose changes to the label not impacting on the SmPC.

This applies to the information in the critical health information panel.

Orientation of text

The text in the critical health information panel should be orientated in the same direction to make it easier for people to read it. Portrait layout rather than landscape may make it easier to read the information.

Use blank space to emphasise critical information

The space for providing information in the information panel is limited and the critical health information panel should not include information such as company logos, trademarks or graphics as this unnecessarily restricts the space available for essential information.

Give due prominence to the generic name(s) of the active ingredients

The generic name(s) should be given due prominence through the choice of point size, font or emboldening. Non-statutory information should be subordinate in placement and prominence to the generic name(s) of the active ingredients. Prominence is determined by factors other than size of the text.

Do not add trailing zeros to numbers

Where possible, always use whole numbers. Different strengths of the same medicine should be expressed in the same way (e.g. 250mg, 500mg, or 1000mg).

Use body text that is readable

Use the largest text size you can on all components. Where appropriate, move company details onto a side panel to afford a greater amount of space for the critical health information. People find it easier to read dark text on a light background, so where very small text sizes have to be used, printing which is blue or black on a light background should be considered.

Use upper and lower case

Entire sentences in capital letters or italic type are hard to read. Do not use capitals or italic type where there is an alternative method of emphasis, such as bold type. Mixed upper and lower case should always be used for sentences.

Boxes should be used where user testing shows they help highlight information

When information is put in boxes, the eye can scan round them not taking in the information. Although some of the statutory warnings are required to be in boxes, generally, boxes should not be used for critical health information, unless user testing shows they are helpful.

Align text to the left

An irregular amount of space between words affects legibility. Align text to the lefthand margin and even out word spacing. Ensure word spaces are clear but narrow.

Use active language

Instructions should be given in active language in all parts of the information so that people are given clear instructions that they can act upon. For example:

Dosage: “Take one or two tablets”, rather than “one to two tablets to be taken”. “Do not give to children under 12” rather than “not suitable for children under 12”.

DOs

Instructions should be given in active language in all parts of the information so that people are given clear instructions that they can act upon. For example:

  • “Take one or two tablets”, rather than “one to two tablets to be taken”.
  • “Do not give to children under 12” rather than “not suitable for children under 12”.
  • Use dark text on a light background.
  • Consider including the barcode on a side panel to free up space for the statutory information.
  • Mock-ups of real packs may be needed to evaluate the impact of colours and fonts.

SmPCs - Section 2

Sections of the SPC relevant to this section of the Code of Practice are:

Section 2: Qualitative and quantitative composition (states the active ingredients).