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. The outer packaging of medicinal products is required to include the information set out below. 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.
The Best Practice Guidance on the Labelling and Packaging of Medicines1 issued by MHRA makes reference to the “critical information” which is necessary at the point of use and recommends that this information is placed together on the pack in the same field of view. This is largely followed already by OTC manufacturers. Various names have been used for the panel on the pack which includes this information. PAGB proposes calling it the “critical health information panel”. The advice given in this section draws on the MHRA Best Practice Guidance and the National Patient Safety Agency Guidance.2
While labelling must contain all elements required by legislation, the critical information which must appear in the same field of view is:
Where space constraints make it difficult to fit all the statutory information on to one face of the label, priority should be given to this information. These items of information should be located together on the pack and should not be broken up by additional information, logos or background texts or graphics. The following information gives guidance to help companies produce information which is clear and legible. It has no statutory basis and it will be amended by PAGB in co-operation with the MHRA as experience with the Code develops and feedback from tests with consumers provides new information.
People find it easier to read dark coloured type (e.g. black or dark blue on a light coloured background e.g. white, pale pink, pale yellow). Strongly reflective packs also present difficulties for readers and companies who wish to use coloured or reflective backgrounds must ensure that the type chosen is still readable. Testing the packs with users can give helpful information in this respect but this is not mandatory.
The full product name, including the common name(s) of the active(s), must appear once in the critical health information panel. If it is used often then it could use up space that would reduce the area available for other essential information or force the use of a smaller font size than would otherwise be necessary.
1. MHRA, 2003, Best Practice Guidance on Labelling and Packaging of Medicines
2. National Patient Safety Agency, 2006, Information Design for Patient Safety