Artwork Review: Key steps, Best Practices and Common Issues

Artwork review is often perceived as a routine regulatory activity. However, high-quality artwork and a streamlined review process are extremely important for pharmaceutical companies, as they have a significant impact on patient safety, production planning, and ultimately the uninterrupted supply of medicines.

A robust artwork review process goes far beyond simple text comparison. Reviewers must verify that approved product information has been accurately implemented, assess readability and ensure compliance with country-specific requirements. From package leaflets to the smallest labels, every component requires careful assessment.

In this article, we outline the key steps, best practices, and common issues in artwork review, focusing on medicinal products intended for the European market. The aim is to provide a practical framework that helps regulatory and artwork professionals perform consistent, efficient, and compliant reviews.

Patient Information Leaflet

Text verification

The first and the most important thing to pay attention to when checking the leaflet artwork is to verify the correctness of the text. Text from the reference document must be accurately transferred, which means that there are no accidental omissions, additions of text, and the information is presented in the correct order. To ensure this it is essential to use the correct reference text. It should be the latest approved product information, unless the artwork is being prepared at risk, before the approval is granted by National Competent Authority (NCA). In such case, Regulatory Affairs (RA) team must ensure that when approval comes the product information is in fact the same as the one used for the artwork preparation.

In case of spelling or translation mistakes which are also present in approved product information, there are two ways to proceed. Some companies prefer to correct any minor mistakes in artworks immediately while others strictly stick to approved product information and first introduce the corrections to the approved texts through variation procedures

Formatting

The next step in artwork review is checking the formatting. We must pay attention to the use of bold, italics, underline, bullet points and so on. However, when it comes to formatting, there are typically two different cases:

1. some formatting is considered as a design element, so-called house style, and is not reflected in approved product information. However, it’s use is justified by successful User Readability Test, therefore it can differ from the approved text.
2. in case some formatting, usually related to patient safety, is reflected in approved product information (PI) but does not come from QRD template, it must be followed on artwork as well.

Special cases

It is worth mentioning that there are several important aspects of the patient leaflet which require not only general text comparison, but also specific knowledge and information. There might be some differences between the approved text and the printed leaflet:

• Printed leaflet must always contain the current adverse event reporting system information, not the reference to Appendix V.
• Printed leaflet must clearly identify the manufacturer which released the particular batch.
• Printed leaflet should mention only the concerned local representative. In case of multi-lingual leaflets, the list of local representatives can be added only once at the end of the printed leaflet.
• Revision date must always be indicated in the printed leaflet even though it is not stated in the approved PI.
• Some countries have blue-box requirements for patient leaflets.

Readability

After the information in the leaflet is checked, another look should be taken to assess the readability. The information in the patient leaflet should be legible and clear. Large part of readability is the font size which should be:

• not smaller than 9 points in monolingual leaflets
• not smaller than 8 points in multilingual leaflets

Otherwise, the readability of the leaflet is assessed by Readability Testing or is bridged to it and is subject to Health Authority (HA) assessment.

Other Packaging Components

Even though significantly less information is provided on other packaging components compared to the leaflet, usually there is considerably more variability and differences in requirements between countries. While reviewing artworks of packages, we should follow similar steps as for package leaflets.

Text verification

During text verification of packaging artworks, it should be ensured that all required information is stated at least once and that only approved labelling text and blue box (when needed) is included. For example, shaded text which is othen used in the labelling text to mark which part may not be printed on the actual artwork, should be always considered and carefully checked.

It should be noted, that on packaging components, especially boxes, essential information might, or even must, be repeated multiple times to make the identification of products easier. While some countries rely on readability guideline with some room for flexibility and interpretation, others have very specific guidance for text arrangement of the carton. E.g., French guidelines for oral solid dosage forms discuss what information is recommended to be listed on which side of the box, how many times and even in which orientation.

Braille

Another important aspect of text verification is Braille, which also must be in line with approved labelling and regulatory reviewer is expected to check Braille characters themselves, not the text underneath so they should be available.

Also since there are differences in Braille in different countries and languages, we need to check it against the national Braille alphabet unless national authorities advise otherwise.

Special attention should be made to punctuation marks and symbols which indicate uppercase letters, because most differences are usually identified in them.

Blue box

Some countries may ask for additional information to appear on the outer packaging which should be accommodated in a single boxed area (so-called ‘blue box’). Each ‘blue box’ should only be presented in the official language or languages of that country and should clearly indicate the country to which it applies. The location of the ‘blue box’ and its dimensions should ideally be the same for all countries.

It should be mentioned that different documents define Blue-box requirements for Centrally authorised products and NP/MRP/DCP products:

• For CP: Notice to Applicants. Guideline on the packaging information of medicinal products for human use authorised by the Union.
• For NP/MRP/DCP: CMDh: “Blue – Box” requirements

Readability

Once the correctness of the text on the artwork has been verified, the artwork should be assessed again for readability, for example:

• Is the font easy to read
• Can symbols be easily distinguished from each other
• Is there a contrast between the text and the background.

As a reminder, particulars on the label should be printed in characters of at least 7 points, leaving a space between lines of at least 3 mm.

Also one important note regarding the name of the medicinal product on the package – the full name may be presented on different lines or in different font sizes, if needed, but the appearance of the name shall remain as an integrated item.

Colours

Colours on the artwork should be chosen to ensure a good contrast between the text and the background.

For example, Highly glossy, metallic, or reflective packaging should be avoided, as this affects the readability of the information.

Different colours in the name of the product are discouraged since they may negatively impact the correct identification of the product name.

The number of colours used on packs needs careful consideration as too many colours could confuse.

However, the use of different colours to distinguish different strengths or pharmaceutical forms is strongly recommended or even mandatory in some countries.

Finally, the same colour that is used on the outer pack is recommended to be carried onto primary packaging to aid identification of the medicine.

Symbols and Pictograms

The outer packaging as well as the package leaflet may include symbols or pictograms designed to clarify certain information compatible with SmPC and useful for the patient.

However, as stated in the Readability Guideline – if there is any doubt about the meaning of a particular pictogram it should be considered as inappropriate.

Furthermore, symbols and pictograms used on both leaflet and labelling must exclude any element of a promotional nature.

Finally, background images should not be placed behind the text since they may interfere with the clarity of the information, making it harder to read.

Multilingual Packages

Another important topic is multilingual packages. In such cases, the information should be grouped per language when feasible. When space does not allow the display of all information in different languages on the same panel, each panel should be used per language.

There should also be a clear demarcation between different languages where space permits.

And finally, we need to ensure that the text is in fact the same between different languages. In case any differences are identified they should be escalated to RA team and unified with the next available opportunity.

Submission to Health Authorities

After the successful review of the artwork, it must be considered whether health authority approval is required.

Different NCAs have different requirements for artwork submissions or notifications.

It should be considered if artwork submission is required (for instance, approval required for every change, for significant changes only, or notification for information only), or not and, is so, at which point (along with the procedure, after approval or before placing the product on the market).

If HA approval is obtained, it must be checked if the production artwork is in line with the approved one.

Conclusion

While artwork review might look like one of the simpler regulatory tasks, it is one of the most important safeguards in ensuring that product information is communicated accurately, clearly, and in compliance with regulatory requirements. Although text verification remains at the core of the review process, it is only one part of a broader assessment that includes readability, formatting and other country-specific requirements.

By applying a structured and consistent approach, regulatory and artwork professionals can identify potential issues before products reach the market and support both regulatory compliance and patient safety.