Braille on Pharmaceutical Packaging in Russia Remains Voluntary as the PNST 556 Standard Lapses
For years, quality departments routinely included Braille in printing specifications as a mandatory requirement. Regulatory affairs specialists incorporated it into packaging artwork without question, citing a specialized technical document from Rosstandart. Everyone assumed they were complying with the law, just as in the European Union.
On 1 June 2025, that document formally lapsed. No replacement has been issued to date, and at the level of the Eurasian Economic Union (EAEU), Braille on medicine packaging has never been a mandatory labeling element. It remains optional supplementary information added at the manufacturer’s discretion.
How Companies Interpreted the Requirement Until Mid-2025
The momentum behind technical standards for Braille in Russia originated with the ratification of the UN Convention on the Rights of Persons with Disabilities on 13 December 2006. Formally, it addressed an accessible environment in a broad sense: education, transport, urban infrastructure. The preamble to GOST R 56832-2020 directly cites its principles and grounds that link in the need for a unified information space for the visually impaired. Pharmaceutical packaging became a logical field to apply these principles: a mix-up caused by indistinguishable vials threatens patient health.
In 2021, Rosstandart, together with the Institute of Professional Rehabilitation of the All-Russian Association of the Blind, approved Preliminary National Standard (PNST) 556-2021, «Placement of Braille Information on Packaging of Medical Devices and Medicinal Products.» Clause 4.1.2 was explicit: Braille labeling must be applied to the secondary packaging of medical devices and medicinal products.
The document detailed the required content of the Braille inscription. Packaging was expected to display the brand name or international nonproprietary name, dosage form, strength, and expiration date. Exemptions included primary packaging when secondary packaging was present, injectable and infusion preparations, and medicinal products intended exclusively for healthcare professionals (vaccines, sera, and select immunobiologicals). Simplified rules applied to herbal products and pack sizes with a printable surface under 10 cm².
For the geometry of the characters themselves, PNST 556-2021 cross-referenced a separate document, GOST R 56832-2020, «Braille. Requirements and Dimensions.» Effective since 1 June 2021, this standard replaced the 2015 edition. Its scope extends far beyond a single industry: school education, publishing, tactile signage and stickers, and packaging. It establishes two font sizes, standard and small. The small font is prohibited for children’s literature and publications for the recently blind.
Several methods are used in practice to create the dots. Embossing forms relief between a punch and die and remains the most common method for folding cartons. UV printing applies drops of specialized varnish that polymerize instantly under UV light, which suits short runs without risking damage to the reverse side of the carton. For vials and ampoules, where direct embossing on glass is impossible, self-adhesive tactile labels are applied on the packaging line instead.
Standard font parameters require horizontal and vertical dot spacing of 2.7 mm within a character, character width including inter-character spacing of 6.6 mm, word spacing of 13.2 mm, line height of 10.8 mm, and a base punch diameter of 1.4 to 1.5 mm. The small font scales these down: 2.5 mm, 6.0 mm, 12.0 mm, 10.0 mm, and roughly 1.3 mm respectively. Dot height itself must fall between 0.5 and 0.7 mm, and dot deviation from the horizontal or vertical axis within a line cannot exceed 0.1 mm.
Substrate materials carried their own requirements. Paper for Braille printing must have a grammage between 135 and 160 g/m², stay resilient, and avoid creating background tactile texture around the dots. Film materials, conversely, must not be too smooth: fingertips stick to an ultra-smooth surface because of natural skin moisture, which slows reading.
Companies supplying the EU market work under a different logic, one that regulatory affairs managers running parallel registrations need to keep in mind. Directive 2004/27/EC made Braille mandatory on the outer packaging of medicines in the EU from 30 October 2005 for all new marketing authorizations. The corresponding technical standard, ISO 17351:2013, sets a target dot height of about 0.20 mm, well below the 0.5 to 0.7 mm required under GOST R 56832-2020. Height is checked with a calibrated spring-loaded micrometer at a minimum of three points per batch, with no more than 5% of measurements allowed below the threshold. Artwork approved for the European market fails Russian dot geometry, and vice versa: a single template cannot serve both jurisdictions, so separate print files are required.
Quality verification follows the same logic regardless of which standard applies, Russian or European: dot height on the first impression matters, but so does process stability across the run. GOST R 56832-2020 does not spell out a statistical sampling method the way ISO 17351:2013 does, but both standards face the same underlying problem: the embossing die wears down over a run, and a dot that looks ideal at the start of printing can lose height by the end of the batch. In-process quality control needs to confirm both first-impression conformity and stability across the full order.
Artwork layout also mattered. PNST 556-2021 prohibited placing Braille over barcodes or QR codes, since the raised dots cast shadows that confuse scanners; over decorative borders or ornamental patterns, which create tactile clutter; over the brand name or international nonproprietary name printed in ordinary type; and across fold lines on secondary packaging, where dots break down quickly. These restrictions were not specific to Braille labeling: they reflect general packaging design logic, in which any printed element gives way to information that matters for patient safety. Designers should keep these rules on their checklist even after 1 June 2025. Legal obligation attached to them is gone; the industry practice behind them remains.
What Changed After PNST 556-2021 Lapsed
Preliminary national standards are approved for a limited period, no more than three years, under Part 15, Article 2 of Federal Law No. 162-FZ of 29 June 2015, «On Standardization in the Russian Federation.» When that period ends, a document is either converted into a full GOST R or lapses. PNST 556-2021 took the second path: as of 1 August 2026, its status in the Rosstandart registry reads inactive, and no replacement has been announced.
There is a more important point here. Even the text of PNST 556-2021 itself, in its «Scope» section, stated plainly that the Russian Federation had no statutory or regulatory document at the time governing Braille labeling requirements for medical devices and medicines. The standard was an attempt to close that gap at the technical level. It never became a full legislative norm, then or now.
At the EAEU level, the question was settled differently from the start. Decision of the Council of the Eurasian Economic Commission (EEC) No. 76 of 3 November 2016, «On Approval of Requirements for the Labeling of Medicinal Products for Human Use and Veterinary Medicinal Products,» states directly that secondary packaging may carry additional information, including duplicate labeling text in other languages or in Braille, and symbols or pictograms that help clarify information for the consumer. The word «may» signals a manufacturer’s right, not an obligation.
Federal Law No. 61-FZ of 12 April 2010, «On the Circulation of Medicines,» lists in Article 46 an exhaustive set of data that must appear on primary and secondary packaging in clearly legible Russian text: product name, batch number, release date, shelf life, dosage, method of administration, and other items. Braille does not appear on that list. The Ministry of Health’s position has not changed in years: the law allows for the possibility, and it does not turn Braille into a mandatory norm.
Two senses of the word «labeling» get confused often enough to spell out separately. Administrative liability under Article 6.34 of the Russian Code of Administrative Offenses (KoAP RF), which carries fines of 50,000 to 100,000 RUB for legal entities along with confiscation of the goods, concerns identification marks in the national drug-traceability monitoring system, the Data Matrix codes of the «Chestny Znak» (Honest Sign) track-and-trace scheme. That system has nothing to do with the informational content printed on packaging, Braille included. Treating the absence of Braille as a trigger for fines under Article 6.34 is incorrect: no legal provision requiring Braille exists to support that inference.
A similar mix-up happens with EEC decisions. Requirements for the package leaflet and the summary of product characteristics are set out in a separate act, EEC Council Decision No. 88 of 3 November 2016, which governs the package leaflet and contains no rules on packaging labeling. The rules that actually govern labeling, including the mention of Braille as a permitted element, sit in Decision No. 76. Citing the wrong decision number in a submission or in correspondence with a regulator reads as carelessness and undermines confidence in the rest of the document.
For regulatory affairs managers, the PNST 556-2021 story is useful for one more reason. It illustrates a pattern common to niche accessibility and assistive-technology topics: a technical community has an incentive to fix detailed requirements in a preliminary standard, but the standard’s status expires after a few years, and the responsible agency does not always manage to carry it through to a full GOST R in time. Other PNST documents in adjacent fields may follow the same path. SOPs and vendor contracts should build in a periodic check of the status of every referenced standard rather than assuming any of them stay in force indefinitely.
| Parameter | Before 1 June 2025 | After 1 June 2025 |
|---|---|---|
| Status of PNST 556-2021 | Active, with the wording «must be applied» | Inactive, the standard has lapsed |
| Mandatory status in Russia | Widely treated as mandatory under PNST | Not established by any active document |
| Status at EAEU level | Decision No. 76: permitted element | Unchanged, remains voluntary |
| Technical font standard | GOST R 56832-2020 | Unchanged, still in force |
| Replacement for PNST 556-2021 | — | None developed as of publication |
What to Do
Audit your internal documents. Pull packaging specifications, print-shop work orders, carton supplier contracts, and quality-control SOPs. Where PNST 556-2021 is cited, replace the reference with GOST R 56832-2020, which remains the active technical benchmark for dot geometry. Check incoming packaging inspection checklists in particular: outdated references tend to survive there longest.
Reconcile with the marketing authorization dossier. If your approved packaging artwork already includes Braille, the lapse of PNST does not authorize removing it without filing a variation. A mismatch between the packaging on the line and the approved artwork is a bigger inspection risk than the underlying question of whether Braille was ever mandatory.
Keep artwork separate by market. For EU exports, work to ISO 17351:2013, target dot height about 0.20 mm. For the domestic EAEU market, work to GOST R 56832-2020, target range 0.5 to 0.7 mm. A single artwork file cannot serve both: the dot geometry differs by more than double, so production needs separate print files and separate validation for each.
Revise marketing and tender language. Any claim that Braille labeling is a legal requirement in Russia is factually wrong. Replace it with a description of a voluntary accessibility measure carried out to GOST R 56832-2020. This removes the risk of a misrepresentation claim and still signals good faith to the market.
Ask about the replacement standard. Contact Rosstandart Technical Committee TK 381, which covers technical aids for people with disabilities, and ask about plans to replace PNST 556-2021 with a full GOST R. The answer is useful for updating internal procedures over the next one to two years, and for getting ahead of the requirement if it becomes mandatory after all.
The absence of a formal obligation does not erase the practical value of Braille for companies that have already invested in tactile packaging for accessibility or for EU export. Only the frame changes: instead of a line item on a compliance checklist, it becomes a voluntary part of product policy, one that still needs technical discipline, precise dot geometry, and consistency with the registration dossier. Companies that had not yet added Braille, and were treating it as a mandatory item on a delayed timeline, can use the current pause to choose a technology and a materials supplier without rushing. Accessible packaging for visually impaired patients still counts as a real competitive factor at retail, regardless of what the current standards registry says about it.
Statutory and Regulatory References:
1. ISO 17351:2013, «Packaging — Braille on packaging for medicinal products» (reference only, for comparison with the EU market)
2. Federal Law No. 61-FZ of 12 April 2010, «On the Circulation of Medicines» (Article 46)
3. Decision of the Council of the Eurasian Economic Commission No. 76 of 3 November 2016, «On Approval of Requirements for the Labeling of Medicinal Products for Human Use and Veterinary Medicinal Products» (as amended 23 September 2022)
4. GOST R 56832-2020, «Braille. Requirements and Dimensions»
5. PNST 556-2021, «Placement of Braille Information on Packaging of Medical Devices and Medicinal Products» (lapsed effective 1 June 2025)
6. Federal Law No. 162-FZ of 29 June 2015, «On Standardization in the Russian Federation» (Part 15, Article 2)