Why the same drug packaging design gets rejected by Rospatent, EAEU reviewers, and Rospotrebnadzor
A medicinal product’s packaging layout is almost always approved by the marketing department rather than a legal professional. By the time a regulatory affairs manager sees the final design, the print run has already been ordered and the trademark application has already been filed. It is precisely at this point that a decision that seemed purely aesthetic turns into a ground for rejection.
Rejections can arrive from several places at once. Rospatent may reject a trademark application due to similarity with another company’s brand. The expert organization of a Eurasian Economic Union (EAEU) member state may deem the registration dossier incomplete because of an illegible leaflet. Rospotrebnadzor may demand that the packaging be redesigned because of an untranslated English slogan. For a company launching a product on the EAEU market, these are three entirely distinct procedures with different timelines, different reviewing bodies, and different costs of error.
The core problem is that these procedures are almost never coordinated with one another. The trademark application goes through Rospatent, the drug registration dossier goes through the competent authority of a member state, and compliance with language requirements is checked by Rospotrebnadzor. Each authority evaluates the same packaging mock-up against its own criteria, and a positive outcome with one gives no guarantee of approval from another.
For a company launching a product in several EAEU markets at once, this risk multiplies by the number of member states involved. Registration of a medicinal product in the Union is built on the principle of mutual recognition: the review carried out by the reference state becomes the basis for recognition in the other member states, while each of them retains the right to raise its own objections at its stage of the procedure. A layout that an expert in one country considers acceptable may be sent back for revision by an expert in another country, specifically over the wording of the Summary of Product Characteristics (SmPC).
Packaging Design Without Legal Review
For a long time, packaging was treated as a branding element rather than a subject of legal review. Bottle shape, box color, and logo placement were discussed at the level of the design studio and the sales team. The legal department stepped in only at the final stage, to check the mandatory text elements and the Eurasian Conformity mark.
Regulatory specialists checked the text of the patient leaflet against the dossier but rarely assessed whether a patient could tell two dosages of the same drug apart by packaging color or font. Trademark applications were filed separately from the marketing authorization, often several months after commercial launch. The logic was simple: get the product to market first, secure the brand later. Searches for confusing similarity were carried out selectively, mainly for new brand names rather than for every redesign of an already-launched product’s packaging.
Language requirements for design, beyond Articles 8-10 of the Law of the Russian Federation of 7 February 1992 No. 2300-1 «On Protection of Consumer Rights» (hereinafter — the Consumer Rights Law), were practically nonexistent. A foreign-language slogan on packaging was seen as a marketing device to signal premium positioning, not as grounds for administrative liability. Companies focused on exporting into the EAEU rarely considered that a design approved in the country of manufacture would have to be adapted separately for each competent authority’s requirements.
This arrangement worked as long as each procedure reviewed the layout in isolation. A trademark application could sit unfiled for months, the registration dossier went through substantive review of the drug itself, and language compliance was handled locally by advertising counsel. The problem starts where these three tracks meet on the same physical packaging mock-up: a design that clears substantive review is rejected on form, and vice versa.
Three developments have changed this picture: tighter Rospatent enforcement on misleading-designation grounds, the extension of dossier-completeness requirements to the content of the Summary of Product Characteristics, and new statutory language rules that took effect on 1 March 2026. The four independent points where design can now become grounds for rejection are set out below.
Trademark and Industrial Design
Article 1483 of the Civil Code of the Russian Federation (hereinafter — the Civil Code) directly prohibits the registration of signs capable of misleading the consumer about the product, its manufacturer, or its place of origin. Rospatent refuses registration under this provision if a design element implies a country of origin, composition, or properties the product does not have — for example, a Swiss flag on a product made elsewhere. The second common ground for refusal is confusing similarity to an already-registered mark in the same product category.
A similar logic applies outside Russia. On 30 October 2025, the Fourth Board of Appeal of the European Union Intellectual Property Office (EUIPO) upheld a refusal to register the bottle shape used in the Dior Addict line. The Board found that a transparent rectangular bottle with a metallic spherical cap does not depart from the shapes customary in the perfume sector, and therefore does not function as an indicator of a specific manufacturer. It did not accept the rights holder’s argument that the bottle’s visual identity matters for recognition on social media: the growing marketing importance of packaging appearance does not, on its own, create distinctive character in the legal sense. The case illustrates a principle equally relevant in Russian practice: aesthetic originality does not substitute for departing from industry norms if the shape remains a standard variant for the category.
Russian applicants have a way to mitigate this risk. If a refusal is based on similarity to another party’s mark rather than on the sign itself being misleading, the applicant can overcome it with a letter of consent from the holder of the earlier mark, or by acquiring rights to that mark. Intellectual Property Court precedent allows a refusal to be challenged if the applicant can show there is no real likelihood of confusion in the eyes of the consumer. This route takes time and requires negotiating with a competitor, so it is cheaper to avoid grounds for refusal at the design stage than to contest a Rospatent decision after the fact.
The Medicinal Product Registration Dossier
The requirements for the patient information leaflet and the Summary of Product Characteristics (SmPC), approved by Decision of the Council of the Eurasian Economic Commission No. 88 of 3 November 2016 (hereinafter — Decision No. 88), require that information for the patient be formulated clearly and concisely. If these requirements are not met, the registration dossier or a variation to it is deemed incomplete, and the applicant is given a deadline to supply the missing materials under the procedure set out in the Rules on Registration and Examination of Medicinal Products, approved by Decision of the EEC Council of 3 November 2016 No. 78 (hereinafter — Decision No. 78, as amended on 26 November 2025).
The practical consequence for packaging design is direct. Decision No. 88 requires the drug’s appearance to be described in Section 3 of the SmPC, including color, markings on the tablet, and other visual features, where such data is confirmed in the dossier. If different strengths of the same drug are visually almost indistinguishable and the SmPC description does not allow them to be told apart, the reviewer is entitled to request that the layout be revised as part of the dossier comments. This is not a formality: confusion between dosage strengths caused by similar-looking packaging is a recognized cause of medication errors, and the competent authorities of the member states take such comments seriously.
Decision No. 78, as amended by Decision of the EEC Council of 22 May 2025 No. 34, also sets a deadline of 31 December 2025 for submitting applications to bring national registration dossiers into line with the Union’s requirements. For marketing authorization holders who submit their applications after that deadline, what is at risk is the ability to complete the alignment procedure itself, regardless of the quality of the packaging design. In practice, though, the two processes overlap: companies updating their dossiers to EAEU rules are, at the same time, obliged to bring packaging layouts into line with the current SmPC description requirements — and it is more efficient to do this in one cycle rather than two separate ones.
Consumer Information on Packaging
Since 1 March 2026, a new Article 10.1 of the Consumer Rights Law, introduced by Federal Law No. 168-FZ of 24 June 2025 (hereinafter — Law No. 168-FZ), has been in force. The provision requires that consumer information, including labeling and text on packaging, be presented in Russian as the state language of the Russian Federation. Slogans such as «Natural Origin» or «Best Choice» without an equally prominent Russian translation fall under this requirement, on the same footing as shop signs, menus, and product listings in online stores.
The one durable exception concerns registered trademarks and company names. If a foreign word on the packaging is registered as a trademark, it does not need to be duplicated in Russian. That makes trademark registration not only a way to protect a brand but also a lawful way to keep the original design without reworking the layout to meet the new law. Companies that have already filed a trademark application should keep proof of filing — the fee payment receipt and the incoming application number from Rospatent — because enforcement practice under Article 10.1 is still forming, and a confirmed pending application reduces the risk of claims during the transition period.
Liability for breaching Article 10.1 currently rests on the general rule on the consumer’s right to information, under Part 1 of Article 14.8 of the Code of Administrative Offenses of the Russian Federation (hereinafter — the Administrative Offenses Code), which carries a fine for legal entities of 5,000 to 10,000 rubles. For materials that qualify as advertising, Article 14.3 of the Administrative Offenses Code may instead apply, with a fine for legal entities of 100,000 to 500,000 rubles. The difference between the two is significant, and which one applies depends on the context in which the text appears on the packaging, not simply on whether a translation is missing.
Unfair Competition
Federal Law No. 135-FZ of 26 July 2006 «On Protection of Competition» (hereinafter — Law No. 135-FZ) treats copying the overall style of a competitor’s packaging as unfair competition through the creation of confusion. The Federal Antimonopoly Service (hereinafter — FAS Russia) has reviewed cases of this kind involving household chemicals, confectionery, and other mass-market goods, where the consumer, making a quick choice on a pharmacy or store shelf, relies primarily on the color and composition of the packaging and only secondarily on the brand name. To establish a violation, three things must be shown: a competitive relationship in the same market, an advantage gained from another party’s reputation, and a real likelihood of confusion in the buyer’s perception.
Unlike a Rospatent refusal, which happens at the application stage, a FAS Russia case can arise only after launch, on a competitor’s complaint. That means a higher cost of error: stock already in circulation has to be changed in the middle of an open dispute rather than quietly reworked before printing. A finding by a FAS Russia panel that Article 14.6 of Law No. 135-FZ has been breached does not by itself cancel a trademark registration or a marketing authorization, though it creates a precedent a competitor can rely on in a separate claim to protect its exclusive rights, and it creates reputational risk that is harder to fix than reworking a layout. A company whose product already holds a shelf position should periodically check for similar-looking packaging appearing among new entrants to the category.
Comparative Risk Matrix
| Procedure | Governing Rule | Ground for Risk | Consequence |
|---|---|---|---|
| Trademark registration | Art. 1483, Civil Code | Confusing similarity; misleading sign | Rospatent refusal, re-filing |
| Medicinal product registration | Decision No. 78, Decision No. 88 | Illegible or ambiguous visual information in the dossier | Dossier deemed incomplete, request to revise the layout |
| Consumer information | Art. 10.1 Consumer Rights Law, Law No. 168-FZ | Foreign-language text without an equivalent Russian translation | Order to redesign the packaging, fine |
| Market competition | Art. 14.6, Law No. 135-FZ | Imitation of a competitor’s packaging style | FAS Russia proceedings, rebranding requirement |
None of these four grounds belongs to the legal department alone. Rospatent and the EAEU competent authorities work with formal applications, FAS Russia responds to market complaints, and Article 10.1 of the Consumer Rights Law touches everyday marketing and localization decisions. That means a packaging design checklist needs to bring the regulatory specialist, the patent attorney, and the design studio together at the same stage of sign-off, rather than passing the layout down the chain after the decision has already been made.
What to Do
Check the design for confusing similarity before approving the print run. Commission a search of active trademarks in the relevant class of the international classification of goods and services before launch, not after sales have started and complaints have arrived.
File the trademark application in parallel with the drug registration dossier. Do not put brand registration off until after market launch — early filing avoids a gap in protection during the first months of sales and gives grounds for the exemption from Article 10.1 of the Consumer Rights Law.
Bring in a regulatory specialist to sign off on the layout alongside marketing. Checking the design against Decision No. 78 and Decision No. 88 should happen at the sketch stage, not after the expert organization raises comments on a dossier that has already been filed.
Check foreign-language elements of the design against Article 10.1 of the Consumer Rights Law. For every non-Russian word or slogan, establish whether it is matched by a Russian translation of comparable size and prominence, or protected by its own trademark registration.
Document the reasoning behind the visual differentiation of dosage strengths. Explain, in Module 1 of the registration dossier, why the chosen color, typeface, and layout of text let a patient and a healthcare professional reliably tell the different forms of the same product apart.
The cost of a packaging design error grows the further the product moves along the approval chain. A layout corrected at the sketch stage costs a few hours of a designer’s time and one round of review with a regulatory specialist. The same layout, rejected after the print run has been ordered, the trademark application filed, and sales already under way, costs a halt in supply, another round of review, and, if a competitor complains, a public case before the antimonopoly authority. That difference in cost is what determines whether a company builds a design check into its regulatory checklist from the start.
Regulatory Framework:
1. Code of Administrative Offenses of the Russian Federation, Articles 14.3, 14.8
2. Civil Code of the Russian Federation (Part Four), Article 1483
3. Decision of the Council of the Eurasian Economic Commission No. 78 of 3 November 2016 «On the Rules for Registration and Examination of Medicinal Products for Medical Use» (as amended on 26 November 2025)
4. Decision of the Council of the Eurasian Economic Commission No. 88 of 3 November 2016 «On Approval of Requirements for the Package Leaflet and Summary of Product Characteristics of Medicinal Products for Medical Use» (as amended on 21 February 2025)
5. Decision of the Council of the Eurasian Economic Commission No. 34 of 22 May 2025 «On Amendments to Decision of the Council of the Eurasian Economic Commission No. 78 of 3 November 2016»
6. Law of the Russian Federation of 7 February 1992 No. 2300-1 «On Protection of Consumer Rights», Article 10.1
7. Federal Law No. 168-FZ of 24 June 2025 «On Amendments to Certain Legislative Acts of the Russian Federation»
8. Federal Law No. 135-FZ of 26 July 2006 «On Protection of Competition», Article 14.6