EAEU Multilingual Drug Packaging. How to Fit Russian and Kazakh Text on One Carton Without Violations.
Packaging that passes expert review in Russia sometimes fails in Kazakhstan. The reason is rarely the drug itself. More often, it is a single line of translation. The Kazakh version of the warning «Keep out of reach of children» runs 20-30% longer than the Russian original, and on a syrup carton that means two extra millimeters, space that frequently does not exist.
The deadline for mass submission of applications to align registration dossiers with EAEU law expired on 31 December 2025. Companies that filed on time received an extension until 31 December 2027 to complete the process, including approval of packaging artwork. The extension does not remove the task, it only moves the deadline: a unified layout for several languages still has to be designed before that window closes.
For a regulatory affairs (RA) manager, legal logic comes first here. EEC Council Decision No. 76 sets requirements for font size, placement order, and language composition. A layout error means an expert query or a registration refusal.
| Parameter | Separate national print runs | Unified multilingual layout |
|---|---|---|
| Artwork versions per product | 2-3 | 1 (plus stickers where needed) |
| Languages on the carton | 1 (language of the destination country) | Usually 2, Russian and Kazakh |
| Risk when text changes | Each version revised separately | One revision, one review |
| Free space for translation | Unrestricted | Limited by font size, the DataMatrix code, and stickers (no more than 1/6 of the area) |
| Approval procedure | Under each country’s national rules | EEC Decision No. 78, single review by the Reference Member State |
How Multi-Country Packaging Was Handled Before
Before the transition to the common market, the marketing authorization holder (MAH) typically printed packaging separately for each country. The Russian market got a carton with Russian text, the Kazakh market got Russian and Kazakh, and the Belarusian market almost always ran on Russian alone, without an extra translation. Three separate print runs solved the space problem: the Kazakh version did not need to make room for Belarusian text that was not there.
Separate print runs raised packaging costs and complicated warehouse logistics. The manufacturer kept three versions of one artwork file. Any change, a new phrase in the summary of product characteristics (SmPC) or a new batch number, meant edits to three files instead of one. For products with modest sales in any single country, the minimum print run often exceeded actual demand, and part of the stock was written off at the next text change.
EEC Council Decision No. 76 of 3 November 2016, «On Approval of Requirements for Labeling of Medicinal Products for Human Use and Veterinary Medicinal Products» (hereinafter, Decision No. 76), does not prohibit separate print runs. Clause 2 of Decision No. 76 requires labeling in Russian and, where the legislation of a Member State requires it, in that country’s state language. In Belarus, where Russian holds state language status, an additional translation is usually not required. In Kazakhstan, whether Kazakh text is required on consumer packaging depends on national legislation, and in practice it is required for the retail segment.
So «packaging in three languages» almost always means a carton in two languages, Russian and Kazakh, with a sticker system for other national specifics. A literal three-language layout on one carton is needed less often than the phrase suggests. The economics changed once the mass dossier alignment deadline passed: MAHs that filed before 31 December 2025 got an extension to the end of 2027, but they are reworking artwork now, building in a margin for expert queries and follow-up review rounds.
One minimum font size, with no hierarchy of importance
Clause 39 of Decision No. 76 sets one requirement for all text on the packaging: the character size must be at least 7 points, or a font size where the x-height of a lowercase «x» is at least 1.4 mm, with line spacing of at least 3 mm. Decision No. 76 does not set a smaller allowance for secondary information. The requirement is the same for the product name, the composition, and the storage conditions.
Clause 40 adds a placement rule: the product name, dosage, and route of administration must sit within a single field of vision at the largest possible font size. On a multilingual pack, this is the tightest spot in the layout. A name printed in two or three languages has to stay legible without dropping below the minimum size, even once the translation is added. Designers usually solve this with a block structure: the name in every language grouped into one large block, followed by smaller blocks for composition and shelf life.
Exceptions for small packaging
Small packaging gets exceptions. They ease part of the language burden, but only when a specific surface-area condition is met.
| Labeling element | Standard primary packaging | Small packaging (text field area no more than 10 cm²) |
|---|---|---|
| INN (international nonproprietary name) | Mandatory | May be omitted |
| Pharmaceutical form | Mandatory | May be omitted |
| MAH name or logo | Mandatory | May be omitted |
| Route of administration (injectables) | Full text | Abbreviations allowed: IV, IM, SC |
| Dosage, batch number, expiry date | Mandatory | Mandatory |
Basis: Clauses 5, 7, and 33 of Decision No. 76. Abbreviated routes of administration are allowed only on primary packaging with a text field of no more than 10 cm², and this is one of the few places where the act states a surface-area limit outright. Other space constraints follow from the general legibility requirements rather than a stated number. For ampoules and small vials, the exception removes much of the language load: three languages, each reduced to dosage, batch number, and expiry date, physically fit where full text in three languages would not.
A vial’s visual size is deceptive. The actual text-field area on a specific primary package should be measured, not estimated. Two vials of similar volume from different manufacturers can have different surface areas because of label shape and the curvature of the surface. One may clear the 10 cm² threshold, the other may not.
The DataMatrix zone
The DataMatrix code adds its own space requirement. The recommended size for a code of this density (36×36 modules), per GS1 standards, is 16×16 mm. Russian Government Decree No. 1556 of 14 December 2018, «On Approval of the Regulation on the System for Monitoring the Circulation of Medicinal Products for Human Use,» does not fix where on the carton the code must sit: placement is set by the artwork approved in the registration dossier. In practice, the code’s footprint needs to be reserved at the sketch stage, before text in every language is placed on the layout.
EEC Council Decision No. 108 of 27 September 2023, «On Labeling Medicinal Products with Identification Means,» covers the exchange of data between national tracking systems for cross-border trade. For layout purposes, the practical takeaway is that the code and its data stay the same across the whole supply chain within the Union, so its footprint cannot be trimmed to fit an extra language for one market. The free space reserved for the code should stay fixed regardless of which country’s print run it is.
Stickers and how much space they can take
Clause 44 of Decision No. 76 allows manufacturers to skip a full re-translation with every change. Labeling must be uniform across Member States, and information that differs by country, such as prescription status, or wording like «for state programs» or «hospital packaging,» can go on an additional sticker where a dedicated field exists on the secondary packaging.
The sticker’s area must not exceed 1/6 of the total area of the secondary packaging, and it must not cover the original text. This is the only place in Decision No. 76 that states a numerical limit for local-adaptation space in absolute terms, and it is worth keeping in mind at the sketch stage, so the sticker zone is not designed larger than the rule allows.
For orphan drugs, with the agreement of the competent authority, the sticker can be used more broadly, for a full national translation, including items that otherwise stay uniform across all countries (Clause 45 of Decision No. 76). This option eases pressure on the main layout for a narrow group of products, but it requires separate approval and does not apply automatically to retail assortments.
Zoning and visual separation between languages
Clause 48 of Decision No. 76 requires clear separation between texts in different languages but does not prescribe a specific layout. In practice, designers use horizontal zoning by language band, vertical columns, or block grouping by meaning, where the name, composition, and shelf life repeat for each language next to one another. The choice depends on the packaging shape: on elongated cartons, such as syrups and nasal sprays, horizontal bands are easier to read, while on wide front panels, vertical columns save space through shorter lines.
Clause 42 of Decision No. 76 directly allows innovative design methods where space on the packaging is limited. The wording is general and does not spell out specific formats, but it covers multilayer and fold-out labels, where the main language stays on the outer layer and the translation sits inside. This format removes the space constraint at the cost of extra review of the label construction during the expert examination, so it makes sense mainly for dosage forms where standard two- or three-language layouts do not physically fit, even with the small-packaging exceptions applied.
The risk of mixing up strengths
Adding a second and third language does more than shrink the free space. It raises a separate risk that Decision No. 76 regulates on its own: a patient should be able to tell one strength of a product from another without effort. Clause 46 of Decision No. 76 requires a distinct color scheme or another clear visual method for different strengths of the same dosage form. Clause 43 recommends against using different font colors within one product name and warns about the risk of confusing similarly designed packs.
Once two or three languages are packed tightly onto a carton, the designer has less free space left for the color code that marks the strength, and a product line risks looking visually uniform exactly where the rule requires the opposite. This is worth checking separately from text legibility: a layout can pass on font size and language separation and still fail on how well it distinguishes strengths within one line.
Material and logos compete for the same space
Legibility requirements go beyond font size. Clause 43 of Decision No. 76 warns that a glossy surface, metallic finish, or other glare-producing coating reduces legibility. On a single-language carton this effect is minor, because there is less text and it runs larger. On a carton with two or three languages, where every line already sits close to the minimum size, glare on a glossy surface can make a section of text unreadable that passed review on a paper proof but fails on the actual print run.
Clause 41 of Decision No. 76 allows company logos and pictograms on primary and secondary packaging where space allows, as long as they do not reduce the legibility of mandatory information. On a multilingual carton, the branding block and the language blocks compete for the same area. The usual order of work puts the mandatory text in every required language first; branding elements are then fitted into whatever space is left.
Braille is not part of the mandatory minimum
Clause 14 of Decision No. 76 mentions the option of duplicating the labeling text in Braille alongside a barcode, holographic marks, and stickers. The wording of Clause 14 makes this permissible at Union level, not mandatory. What makes Braille mandatory is a separate national requirement in a given Member State, applied on top of Decision No. 76, not in place of it. A detailed look at Braille requirements and the related national standards is outside the scope of multilingual layout, but when planning space for translation, it is worth checking in advance whether an additional national requirement applies to a specific product and market beyond the Decision No. 76 minimum.
Who Reviews the Artwork, and in What Order
Decision No. 76 governs the content of the labeling text. The format for submitting artwork and packaging samples, and the approval procedure itself, are set by EEC Council Decision No. 78 of 3 November 2016, «On Rules for Registration and Examination of Medicinal Products for Human Use» (hereinafter, Decision No. 78). Labeling drafts and packaging artwork are part of the registration dossier and are submitted together with the SmPC and the package leaflet. The expert organization of the Reference Member State reviews them as part of the same dossier, in a single review procedure.
For products registered under national rules before the transition to the common market, artwork is revised as part of the dossier alignment procedure. Under the current text of Decision No. 78 (Clause 173), this procedure may not exceed 70 working days from the date the application is filed. That period applies to the alignment procedure itself. Any later change to the artwork, prompted by expert queries or translation edits, is a separate submission with its own review period.
EEC Council Decision No. 43 of 29 May 2024, which amended Decision No. 78, classifies a change to packaging artwork as a change to the registration conditions whenever it follows from a change to the SmPC or to the quality specification document. The practical consequence for a multilingual packaging project is that any edit to the SmPC text automatically pulls in a revision of the artwork across every language on the carton at once, even if the wording changed in only one section of the document. It is worth budgeting for this domino effect separately when planning a schedule, especially once the layout has already cleared one round of review and is already tight on free space.
The number of languages required on a given carton is set by the national legislation of each Member State the product is sold in. There is no single Union-wide list of required languages. Decision No. 76 sets the layout rules and where text goes, but it does not decide, for the applicant, whether an Armenian or Kyrgyz version is needed for a given market. That has to be checked against the national law of the country of sale before layout work starts. Finding this out from an expert’s query later means losing an entire review round.
What to Do
Check the text-field area of the primary packaging. If it is no more than 10 cm², use abbreviated routes of administration (IV, IM, SC) and drop the fields that are optional for small packaging: INN, pharmaceutical form, and the MAH logo (Clauses 5, 7, and 33 of Decision No. 76). This reduces the language load before layout even starts.
Reserve the DataMatrix zone at the sketch stage. Leave a free area of at least 16×16 mm on the secondary packaging and confirm that no language overlaps the code once the final layout is set. Check this again at every layout revision, not only at the start of the project.
Separate mandatory text from country-specific text. Print the shared part, name, composition, and shelf life, directly in every required language, and move country-specific items to a sticker no larger than 1/6 of the packaging area (Clause 44 of Decision No. 76).
Check font size, line spacing, and color differentiation between strengths. At least 7 points, x-height of at least 1.4 mm, line spacing of at least 3 mm. Put the name, dosage, and route of administration in a single field of vision. Separately confirm that different strengths of the same dosage form stay visually distinct once a second and third language are added.
Test the layout on the actual packaging material, not only on a paper proof. A glossy or metallic surface creates glare that reduces the legibility of dense multilingual text more than it does on a single-language pack (Clause 43 of Decision No. 76). Approve a trial run on the final material before filing, so the application is not rejected for a reason unrelated to the text itself.
File the artwork together with the dossier alignment application. If the application has already been filed, the deadline to complete the process runs to 31 December 2027, but every artwork revision goes through its own review. Budget at least 70 working days for the alignment procedure (Clause 173 of EEC Decision No. 78), plus a separate margin for follow-up review rounds.
A unified multilingual layout saves on print runs, but it shifts the risk from logistics to the review process. Decisions No. 76, No. 78, and No. 108 govern different layers of the same carton: the text, the approval procedure, and the traceability code. Getting these out of sync at the draft stage costs more than it does to redo a finished print run.
The two millimeters that a Kazakh storage warning ran short of rarely come down to a careless translator. More often, they are what happens when a layout designed for one language gets stretched to fit the rest. An RA manager should bring the artwork team into the project before the designer gets the brief, not after the expert sends back comments. The extension to 31 December 2027 is worth spending on a full review of the packaging portfolio, started early, with a margin built in for expert comments. Reworking a layout after expert comments costs more than one extra round of layout work at the draft stage.
Regulatory basis:
1. Russian Government Decree No. 1556 of 14 December 2018, «On Approval of the Regulation on the System for Monitoring the Circulation of Medicinal Products for Human Use»
2. EEC Council Decision No. 76 of 3 November 2016, «On Approval of Requirements for Labeling of Medicinal Products for Human Use and Veterinary Medicinal Products» (as amended 15 May 2025)
3. EEC Council Decision No. 78 of 3 November 2016, «On Rules for Registration and Examination of Medicinal Products for Human Use» (as amended 26 November 2025)
4. EEC Council Decision No. 88 of 3 November 2016, «On Approval of Requirements for the Package Leaflet and the Summary of Product Characteristics of a Medicinal Product for Human Use» (as amended 21 February 2025)
5. EEC Council Decision No. 108 of 27 September 2023, «On Labeling Medicinal Products with Identification Means»