Requirements of EAEU Council Decision No. 88 for the Font and Layout of a Medicinal Product’s Package Leaflet
A patient opens a box of medicine, unfolds a leaflet folded eight times over, and tries to find the right dose for a child. The font is small, the lines run together, and the needed paragraph is lost among a dozen dense sections. For a regulator, this is not a cosmetic detail. A misread leaflet can lead to the wrong dose, which is why the layout of a package leaflet is governed by its own regulatory act, with the same strictness as its content.
The act in question is EAEU Council Decision No. 88 of 3 November 2016, «On Approval of the Requirements for the Instructions for Medical Use of a Medicinal Product and the Summary of Product Characteristics for Medical Use.» It sets out not only what must be written in the leaflet, but how that information must look on the page, so that physicians and patients can find the section they need without effort.
Regulatory managers most often work through the substantive part of Decision No. 88, the structured sections of the Summary of Product Characteristics (SmPC), from the product name down to storage conditions. Requirements for font, spacing, and layout tend to stay on the periphery, even though they decide whether a mock-up clears the readability check on the first attempt.
Disparate Approaches to Formatting Before Harmonization
Before the unified EAEU requirements existed, each member state had its own expectations for how instructions for medical use should be laid out. A manufacturer registering the same product in Russia, Kazakhstan, and Belarus would get different comments from different expert organizations on font size, line length, and where warnings should sit.
The Summary of Product Characteristics (hereafter, SmPC) and the Package Leaflet (hereafter, PL) stayed close in content, but their layout was never centrally defined. Applicants fell back on internal company standards, the habits of a particular reviewer, or European guidance borrowed directly, without adapting it to the Union’s rules.
User testing of leaflets was not applied consistently. Some manufacturers checked a PL’s readability only after complaints from pharmacies and patients, once the product was already on the market, turning layout into a source of post-marketing risk instead of a tool for preventing it.
This inconsistency lengthened regulatory review timelines for registration dossiers. Reviewers sent mock-ups back for formal reasons that had nothing to do with the drug’s pharmacology. Applicants spent weeks re-typesetting the same text for different member states.
What Decision No. 88 Regulates Regarding Content and Layout
Decision No. 88 establishes two documents with different audiences and different jobs to do. The SmPC is addressed to physicians, pharmacists, and reviewers at the authorized body. It is written in professional medical language and serves as the source of information for prescribing the product correctly and monitoring its use.
The PL is addressed to the patient and to the people caring for them. It is drafted on the basis of the SmPC but uses plain, everyday language instead of medical terminology. Both documents form part of Module 1 of the registration dossier and go through regulatory review together.
Comparison of SmPC and PL
| Parameter | SmPC | PL (Package Leaflet) |
|---|---|---|
| Audience | Physicians, pharmacists, reviewers at the authorized body | Patients and their caregivers |
| Language & style | Medical terminology | Plain, everyday language |
| Source of content | Drafted by the applicant from scientific data | Drafted on the basis of the approved SmPC |
| Submission format in the dossier | Text-searchable PDF (Word additionally accepted) | Text-searchable PDF (Word additionally accepted) |
| Layout check | Registration dossier regulatory review | User testing or a bridging justification |
Decision No. 88 states directly that failure to meet the requirements for drafting the SmPC and PL means the registration dossier, or a variation to it, is declared incomplete. The applicant is then given a deadline to submit the missing materials addressing the reviewer’s comments, and the registration procedure is suspended until the issues are resolved.
Applicants submit SmPC and PL drafts for review as a text-searchable PDF; Word is additionally accepted. The requirement for searchable text lets the reviewer search and cross-check wording between sections without retyping it by hand. A mock-up saved as a scanned image with no text layer formally fails this requirement, and the authorized body returns it at document intake, before any review of content begins.
During review, specialists at the authorized body may enter track-changes edits directly in the submitted draft. Only the final, agreed version is subject to approval. Applicant teams are better off keeping a single file with a change history than passing text fragments around by email between the designer, the medical writer, and an outside consultant.
Layout Benchmarks Verified Through Readability
Decision No. 88 does not set out layout as a rigid technical standard with mandatory millimeters for every element. Annex No. 14 describes the factors that a reviewer and focus-group participants weigh when assessing a leaflet’s readability. The applicant demonstrates compliance with these benchmarks through the results of user testing; a paper declaration of compliance is not enough on its own.
These factors fall into two groups. The first, typographical, concerns the physical rendering of the text.
| Layout Parameter | Benchmark under Annex No. 14 |
|---|---|
| Font size | Not less than 8 points |
| Typeface | A legible face without decorative elements, for example Times New Roman |
| Text style | Italics and small caps are undesirable for body text |
| Line spacing | Not less than 3 mm |
| Line length | 75 to 90 mm, for the best reading speed |
| Headings and subheadings | No more than 6 words, visually distinct |
The second group, linguistic, concerns the text itself: short word and sentence length, a moderate share of technical terms, no repeated phrasing, and clauses that are not overloaded with participial or gerund constructions.
Both groups of factors work together. A large font will not rescue a leaflet weighed down with bureaucratic phrasing, and plain text set in a cramped, small font will still fail user testing. The medical writer and the layout specialist solve this problem jointly, in a single pass.
Why Paper Guidelines and Real Mock-ups Diverge
A look at package leaflets already on the EAEU market shows fonts ranging from 7.5 to 9 points, even among approved products. Some mock-ups use a line spacing of around 2 mm instead of the recommended 3 mm, because the manufacturer is trying to fit a growing volume of mandatory text into a fixed sheet size.
Technically, mock-ups like these fall outside the Annex No. 14 benchmarks. The registration dossier can still clear review if user testing confirms an acceptable reading speed and comprehension among three or more participants from the target group. It is worth using the numerical benchmarks as a starting point for layout, and treating the result of testing on real readers as the real verdict: counting points on a font size chart is only a rough check before printing a proof.
Line length affects readability more than it might seem to. A line shorter than 75 mm forces the eye to jump to a new line too often, while a line longer than 90 mm makes it harder to scan across and increases the risk of losing one’s place, particularly for older patients or people with impaired vision.
Meeting these benchmarks does not guarantee the layout will automatically pass regulatory review. The real test is whether an actual user can find, understand, and correctly apply the information in the leaflet, whether through user testing or a properly justified bridging procedure referencing an already-tested leaflet from the same product line. The testing methodology itself is covered in a separate article in this series.
The Black Triangle for Medicines Under Additional Monitoring
For medicinal products subject to additional monitoring, Decision No. 88 requires a specific visual marker. An inverted black equilateral triangle is placed before Section 1 of the SmPC, with each side at least 5 mm long.
Next to the symbol, standard wording is required stating that the product is subject to additional monitoring and asking healthcare professionals to report any suspected adverse reactions. The symbol’s size must stay proportional to the type size of the text that follows it, so the 5 mm figure is a floor, to be scaled up along with a larger body text size.
The same principle carries over into packaging markings and the leaflet, so the patient sees the warning regardless of which document they are holding. The symbol is not decorative: changing its proportions arbitrarily, or dropping it for lack of space on the mock-up, is not permitted.
Navigating the Annexes of Decision No. 88
Decision No. 88 runs to a main text plus close to twenty annexes, and a specialist who only handles layout does not need to read them all. It is enough to know which annex covers which task.
| Annex group | What it covers | Who needs it |
|---|---|---|
| Annex No. 1 | Excipients requiring warning statements | Medical writer |
| Annexes Nos. 2, 3, 8, 13, 19 | Special requirements for specific product groups, for example vaccines | Medical writer, registration manager |
| Annexes Nos. 10–12, 15–16 | SmPC and PL templates and completion rules, including the bridging procedure | Medical writer, layout specialist |
| Annexes Nos. 14, 17, 18 | Leaflet readability and user testing methodology | Layout specialist, user testing manager |
For everyday work, a layout specialist needs Annexes Nos. 14, 17, and 18, plus the templates in Annexes Nos. 10 and 15. The rest come up occasionally, when a product falls into a special category, such as a vaccine or a biological.
Where the Scope of Decision No. 88 Ends
Regulatory managers should keep Decision No. 88 separate from the requirements for primary and secondary packaging markings. Placement of the Data Matrix code, the Eurasian Conformity (EAC) mark, and mandatory information on the box itself is covered by a different act, EAEU Council Decision No. 76 of 3 November 2016, «On Requirements for Marking Medicinal Products for Human Use and Veterinary Medicinal Products» (hereafter, Decision No. 76).
Decision No. 88 governs the content and readability of the SmPC and PL, the documents that describe the product itself. Decision No. 76 governs what has to be printed on the packaging and how. In practice, both acts apply to the same mock-up at the same time. They are reviewed under different modules of the registration dossier, often by different people within the company.
This split explains a common mistake on project teams. The packaging designer adjusts the type on the box to meet Decision No. 76, while the medical writer is separately changing the leaflet’s structure to meet Decision No. 88, and without coordination the two versions drift apart, sometimes only after the reviewer has already signed off on the mock-up.
Relevance in 2026
The large-scale harmonization of EAEU registration dossiers required filing an application for dossier alignment by 31 December 2025. That filing deadline has passed. That does not mean the layout question is settled: for many products, national registration certificates remain valid until 1 January 2027, subject to certain conditions, and dossier alignment work on the SmPC and PL continues alongside ongoing sales.
Companies still finishing their alignment paperwork are running several mock-ups in parallel, often for different reference member states. A layout error caught by a reviewer at this stage delays not just the registration itself, but also synchronizing leaflets across batches already on the market.
The current edition of Decision No. 88 adds to the urgency. Amendments approved by EAEU Council Decision No. 18 of 21 February 2025, in force since 19 April 2025, updated the wording of the annexes, including the SmPC templates and completion rules. Companies that formatted their leaflet two or three years ago against the older wording risk resubmitting a mock-up with outdated phrasing.
What to Do
Check the current edition of the requirements. Decision No. 88 has applied as amended by EAEU Council Decision No. 18 of 21 February 2025 since 19 April 2025. Check SmPC and PL template wording against this version specifically; the original 2016 text no longer applies, having gone through several rounds of amendment since.
Assemble the PL mock-up before filing the dossier. Reworking a mock-up after the first reviewer comments takes longer. Prepare a full-colour, 1:1 scale mock-up with an actual fold line, and hand it to the team running user testing or preparing a bridging justification against an already-tested leaflet in the same line.
Check font size, line spacing, and line length against Annex No. 14 before sending the mock-up to print. A difference of one or two points in type size often decides whether a focus group passes the leaflet on the first attempt, and reworking a mock-up after a reviewer’s rejection can take weeks.
Place the black triangle and its standard wording correctly. If the product is registered under additional monitoring, check that the symbol’s proportions match the surrounding body text, not just that the triangle is present on the mock-up.
Keep SmPC/PL work and packaging-marking work with separate teams, and coordinate them. Decision No. 88 covers the content and layout of the leaflet; placing the Data Matrix code and the EAC mark on the packaging stays within Decision No. 76. Synchronize mock-up versions between the two teams before submission to the reviewing body.
Formatting a package leaflet stopped being the last technical step before printing a run some time ago. A company that checks a mock-up’s readability alongside drafting the text saves months on dossier resubmission and lowers the risk of the dossier being declared incomplete at the first review. The same problem, caught only after a reviewer’s rejection, costs considerably more in time and money.
Regulatory Basis:
1. EAEU Council Decision No. 88 of 3 November 2016, «On Approval of the Requirements for the Instructions for Medical Use of a Medicinal Product and the Summary of Product Characteristics for Medical Use» (as amended, 21 February 2025)
2. EAEU Council Decision No. 78 of 3 November 2016, «On the Rules for Registration and Examination of Medicinal Products for Medical Use»
3. EAEU Council Decision No. 76 of 3 November 2016, «On Requirements for Marking Medicinal Products for Human Use and Veterinary Medicinal Products»