GAP Analysis of a European Dossier for the EAEU. What to Check Now the 2025 Deadline Has Passed
31 December 2025 has passed. Some companies managed to submit an application to bring their dossier into alignment with Union requirements on time and are now moving through the procedure with a three-year buffer. Some did not, and starting 1 January 2026 can sell remaining stock only under the national rules of their own member state, until the end of the shelf life. Others still believe the deadline lies ahead and continue preparing the European dossier as if Modules 2 through 5 merely need a Russian translation.
That is not the case. The registration dossier in the Common Technical Document (CTD) format, adopted by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), is built on shared principles in both the European and the Union versions, but it diverges in Module 1, in the quality normative document, and in a number of technical requirements that simply do not exist in European practice. A GAP analysis surfaces these gaps before the application is filed, rather than after the dossier is rejected.
An additional deadline still applies to some companies: until 1 January 2027, a separate provision covers products that have been on the market for at least the past three consecutive calendar years and did not file an alignment application before the end of 2025. Less than six months remain until that date.
Three Models for Bringing a Product to the Union Market
The unified medicines market of the Eurasian Economic Union (EAEU) covers Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan. The regulatory framework rests on a package of decisions issued by the Council of the Eurasian Economic Commission (EEC). Registration and regulatory review of medicinal products are governed by Decision No. 78, alongside Decision No. 77 on Good Manufacturing Practice (GMP), Decision No. 79 on Good Clinical Practice (GCP), and Decision No. 87 on good pharmacovigilance practice for competent authorities.
The registration rules approved by Decision No. 78 provide for three models for bringing a product to the Union market.
The dossier alignment procedure applies only to products that already hold a national marketing authorization (MA) in one or more member states. The applicant repackages the accumulated data into CTD format without the right to introduce new safety or efficacy data.
The mutual recognition procedure begins with registration in the Reference Member State and concludes with recognition of the regulatory review report in the Concerned Member States. The applicant chooses it independently, and only one state may act in that role.
The decentralised procedure is filed in several member states at the same time, with one of them chosen as the Reference Member State to coordinate the regulatory review.
This is where the first serious mistake tends to appear when briefs and rough estimates from open sources get carried straight into a project plan: the timelines for these procedures are set almost everywhere in business days, not calendar days. The difference is significant, especially over a six-month horizon.
| Procedure | Reference Member State | Concerned Member State |
|---|---|---|
| Dossier alignment | no more than 70 business days | under the mutual recognition procedure (paragraphs 66-82 of the Rules) |
| Mutual recognition | no more than 140 business days | no more than 60 business days for registration (the regulatory review within this period takes up to 40 business days) |
| Decentralised | no more than 140 business days | no more than 50 business days |
These timelines do not include the time the applicant spends responding to queries from the reviewing body; the response window for a single query is usually capped at 90 business days. In practice this means the real length of the procedure almost always exceeds the formal norm whenever the reviewer raises deficiencies.
How to Run a GAP Analysis for Module 1
Modules 2 through 5 are, in theory, meant to be identical across all ICH regions. Module 1 is regional by definition, and it is where most of the rework is concentrated when converting a European dossier into EAEU format.
The first gap is language. The application, the package leaflet, the summary of product characteristics, the packaging artwork, and the Module 2 summaries must be submitted in Russian as the working language of the Union. Some documentation in Modules 3 through 5 is allowed in English in electronic format, but GMP inspection reports from the past three years and a number of other Module 1 documents require a certified translation. Filing through Concerned Member States additionally requires translations of the summary of product characteristics, the leaflet, and the artwork into the official languages of Armenia, Kazakhstan, and Kyrgyzstan.
The GMP certificate usually causes more difficulty. The applicant must submit a valid document confirming that the manufacturing site complies with Union GMP requirements. From 2021 through 2025, mutual recognition of member states’ national GMP certificates was in effect, but that transitional period ended together with the general deadline on 31 December 2025. If there is no valid Union certificate, the applicant may submit an alternative package instead: the national certificate of the manufacturing country, a copy of the most recent inspection report from the past three years, complaint data, and consent to an inspection under Union rules. Based on these documents, the Reference Member State decides for itself whether an unscheduled inspection is required.
The marketing authorization holder must also confirm it has a Certificate of a Pharmaceutical Product in WHO format and a Qualified Person for Pharmacovigilance with contact details in each Concerned Member State.
Readability testing of the package leaflet is easy to miss from the plan. A European readability report obtained on an EU sample usually requires a linguistic justification for its applicability to a Russian-speaking audience, rather than a plain translation.
The Quality Normative Document and the Union Pharmacopoeia
The technical modules (quality, non-clinical, clinical) are closer to the EU CTD, but even here there is an element that simply does not exist in European practice: the quality normative document (ND). This is a standalone document, an extract from Module 3, that serves as the main legal instrument for controlling a product’s quality after registration. Requirements for its structure and format are set out in the guideline approved by EEC Board Decision No. 151 of 7 September 2018 (as amended by Decision No. 137 of 4 October 2022).
| ND section | Source in the CTD |
|---|---|
| Title page | trade name, dosage form, strength, marketing authorization holder |
| Product composition | qualitative and quantitative composition |
| Specification | Section 3.2.P.5.1 |
| Analytical procedures | Section 3.2.P.5.2 |
| Packaging | Section 3.2.P.7 |
| Storage conditions | Section 3.2.P.8.1 |
Where the ND text and Module 3 disagree, the regulator always defers to the data in Module 3, so synchronising the two documents is worth planning as a distinct task, not a formality left for right before submission.
Volume 1 of the EAEU Pharmacopoeia, approved by EEC Board Decision No. 100 of 11 August 2020, has been in force since 1 March 2021. If a product was registered on the common market before that date, the deadline for bringing its normative documents into line with the Union Pharmacopoeia is 1 January 2026. Where a Union monograph for the substance already exists, the specification must reference it directly; European Pharmacopoeia monographs are allowed only where no Union monograph exists, and only with a justification for the applicability of the methods. Certificates of Suitability (CEP) issued by EDQM are recognised by the Union, which noticeably simplifies the substance section.
Stability must be confirmed for specific climate conditions. Union territory falls mostly within Climate Zone II, but some regions require confirmation at higher parameters.
| Storage condition | Temperature | Humidity | Minimum duration |
|---|---|---|---|
| Long-term (standard) | 25±2 °C | 60±5% | 12 months as of the filing date |
| Long-term (alternative) | 30±2 °C | 65±5% | for the Union’s southern regions |
| Accelerated | 40±2 °C | 75±5% | 6 months |
A GAP analysis must separately check for in-use stability data after first opening the pack, because for multidose forms this requirement is often missing from the original European package if the product is sold in the EU only in single-use packaging.
Clinical Data and Ethnic Sensitivity
For the dossier alignment procedure, Modules 4 and 5 can in most cases be submitted as originally prepared, without reformatting the reports under Union good laboratory and clinical practice rules. This follows directly from Section XIII of the Registration Rules. For new registrations through mutual recognition or the decentralised procedure, the requirements are stricter: non-clinical and clinical studies conducted outside the member states are accepted for regulatory review only if they were planned and conducted to standards no lower than the Union’s good clinical and laboratory practice. They must also comply with the principles of the Declaration of Helsinki.
Another question when working with a regional clinical dossier is how applicable data obtained on a European population is to patients in the member states. The Union’s good clinical practice rules, approved by Decision No. 79, were developed taking into account the ICH E5 approach to assessing the influence of ethnic factors on a product’s efficacy and safety. This covers two groups of factors: intrinsic (genetic polymorphism, including cytochrome P450 isoenzymes, age, body weight, renal and hepatic function) and extrinsic (diet, smoking prevalence, standards for concomitant therapy).
If a product has a narrow therapeutic index, non-linear pharmacokinetics, or metabolism that depends heavily on polymorphic enzymes, the Reference Member State may order an unscheduled inspection of the clinical trial or require additional justification in the clinical overview. A well-prepared Section 2.5 of the dossier, with an analysis of ethnic sensitivity, often removes the need for extra studies, but only if the European dossier already built in a methodology for that kind of analysis, rather than general statements about tolerability.
The Electronic Dossier and Common Grounds for Rejection
The dossier is filed as an electronic Common Technical Document (eCTD) with dedicated XML markup: the R.017 structure describes the application data, and the R.022 structure covers the data on the dossier itself and the list of files it contains. Requirements for these structures were approved by EEC Board Decision No. 79 of 30 June 2017 (not to be confused with Council Decision No. 79 on GCP — the numbers match by coincidence, the issuing bodies do not).
When converting a European eCTD package into EAEU format, technical teams tend to run into the same problems. Scanned documents without a recognised text layer fail validation. Password-protected files block the automated check and cause the entire submission sequence to be rejected. The XML manifest must strictly match the current version of the R.022 schema, including document type codes and checksums. Binary file content must not be written directly into the XML attributes — only file paths are allowed.
Every PDF file in the dossier must meet the reviewing body’s format requirements and include embedded fonts. An incompatible PDF version or missing fonts often causes a rejection at the technical validation stage, before substantive regulatory review even begins.
Timeline Extensions Under Decision No. 34
On 22 May 2025, the EEC Council adopted Decision No. 34, which amended the transitional provisions of Decision No. 78 and gave the industry additional time.
| Applicant’s situation | What happens after 31 December 2025 |
|---|---|
| Alignment application filed before 31 December 2025 | commercialisation under the national MA continues for the length of the procedure, up to 3 years from the filing date in the Reference Member State |
| Procedure completed in the Reference Member State before 31 December 2025 | the Concerned Member States allow up to 2 additional years to finish the procedure; the application there must be filed no later than the expiry of the 3-year period from the filing date in the Reference Member State |
| No application filed at all | the product may be sold only within its own member state, under that state’s national law, until the shelf life of the released batches expires |
Russia has one more rule that regulatory departments regularly leave out of their planning: until 1 January 2027, a product may continue to be sold if no alignment application was filed by 31 December 2025, provided that as of 1 December 2025 the product had been on the market for at least the past three consecutive calendar years (Decree of the Government of the Russian Federation No. 353 of 12 March 2022). The requirement itself does not go away: products with an established sales history get a temporary deferral, and only within Russia.
What to Do
Take stock of your portfolio by the end of September. Split products into three groups: alignment application already filed; application not filed but the Decree No. 353 deferral applies; application not filed and no deferral applies.
For every product without a filed application, work out how much time you actually have. If the Decree No. 353 deferral applies, you have until 1 January 2027 to prepare a complete package and file the application; if not, the only route left is a fresh registration through mutual recognition or the decentralised procedure, with no right to repackage the old data.
Start the GAP analysis with Module 1. Check the status of the Union GMP certificate, whether a WHO-format Certificate of a Pharmaceutical Product exists, the Qualified Person for Pharmacovigilance’s contact details in each Concerned Member State you plan to file in, and the status of the leaflet readability report.
Synchronise the quality normative document with Module 3 before the dossier goes to translators. Discrepancies between these two documents are a common source of reviewer queries, and they are cheaper to catch during an internal check than after the Reference Member State raises them.
For products already going through dossier alignment, put the 3-year deadline from the filing date in the Reference Member State on the calendar, along with the separate, earlier deadline for filing in each Concerned Member State.
Companies that filed before the end of 2025 bought themselves time, but not an exemption from Union requirements: the normative document, the language rules, and the question of ethnic sensitivity in clinical data still apply, whether the product goes through dossier alignment or a fresh registration. A GAP analysis done in advance saves exactly the time that a rejection afterward cannot give back.
Regulatory framework:
1. EEC Council Decision No. 78 of 3 November 2016, «On the Rules of Registration and Examination of Medicinal Products for Human Use» (as amended 26 November 2025)
2. EEC Council Decision No. 34 of 22 May 2025, «On Amendments to Decision No. 78 of the Council of the Eurasian Economic Commission of 3 November 2016»
3. EEC Board Decision No. 151 of 7 September 2018, «On Approval of the Guideline for Compiling the Quality Normative Document for a Medicinal Product» (as amended 4 October 2022)
4. EEC Board Decision No. 100 of 11 August 2020, «On the Pharmacopoeia of the Eurasian Economic Union»
5. EEC Council Decision No. 79 of 3 November 2016, «On Approval of the Rules of Good Clinical Practice of the Eurasian Economic Union»
6. EEC Council Decision No. 77 of 3 November 2016, «On the Rules of Good Manufacturing Practice»
7. EEC Board Decision No. 79 of 30 June 2017, «On Requirements for the Electronic Form of Applications and Registration Dossier Documents»
8. Decree of the Government of the Russian Federation No. 353 of 12 March 2022