Technical validation of EAEU dossiers — how a mismatched XML attribute in R.022 causes automatic rejection
A regulatory specialist searching for «electronic dossier eCTD» typically finds English-language materials from the FDA and EMA featuring the index.xml file, DTD schemas, and the leaf attribute. The Eurasian Economic Union (EAEU) prepares electronic dossiers using a different technical logic, and this overlap in terminology misleads even experienced regulatory affairs managers.
The Union has built its own XML structure under code R.022, approved by Board of the EEC Decision No. 79 in 2017, together with a separate document classifier under Decision No. 159. Companies that convert dossiers using Western manuals produce files incompatible with EEC systems and are rejected at the technical validation stage.
Paper Dossiers and Confusion Around International eCTD
EEC Council Decision No. 78 of 3 November 2016 introduced a unified structure for the registration dossier, the five modules of the Common Technical Document (CTD). The decision did not define a submission format. Applicants prepared scanned PDF files, bound them with inventories, and submitted them separately to the competent authority of each member state.
Six months later, Board of the EEC Decision No. 79 of 30 June 2017 approved requirements for the electronic form of applications and registration dossier documents, introducing the XML structures R.022 and R.017. From 2017 to 2022 the rules still required parallel paper copies, so companies kept printing full sets. Expert bodies in the five member states also interpreted the composition of Module 1 differently: there was no single set of guidance for preparing it for States of Recognition, which left applicants with extra uncertainty when filing.
Proprietary Standard R.022 Instead of International eCTD
On 17 March 2022, EEC Council Decision No. 36 abolished the requirement to duplicate the electronic dossier on paper. From that point, applicants could submit a complete package electronically without paper copies, including when filing a dossier alignment application for a national dossier.
The technical backbone of the electronic dossier («эОТД» in Russian regulatory usage) is the EEC’s own XML structure under code R.022, «Information on the Registration File or Registration Dossier of a Medicinal Product» — distinct from the international eCTD standard used by the FDA and EMA. A parallel structure, R.017, describes the registration application itself. The Commission maintains both schemas in the electronic document structures registry on the official Union website and updates them without amending the text of Decision No. 79, so schema currency needs checking before every submission.
The R.022 file carries several mandatory attributes. csdo:UnifiedCountryCode ties the document to a single member state and does not allow more than one value: Module 1 for the reference State and Module 1 for each State of Recognition are compiled as separate XML files. csdo:DocId serves as the unique identifier for each document, while hcsdo:OperationAtribute describes the document’s status for each submission version, starting with the value «new» for the first version.
The sequential submission number, SubmissionSequence, consists of four digits and starts at 0000. Numbering runs independently in each member state, so the reference State and a State of Recognition can receive documents under different sequence numbers on the same day. The rules allow skipped numbers and parallel submissions across states under the same number if the applicant files with all authorities at once.
Each document is assigned a code from the classifier of registration dossier document types, approved by Board of the EEC Decision No. 159 of 17 September 2019. The same act sets out the directory of structural elements of the dossier. Without a matching code from that directory, technical validation rejects the file before it ever reaches a reviewer.
Module 1 stays country-specific: each State of Recognition receives only the documents relevant to it, not the full package prepared for the reference State. Modules 2 through 5 are common to all participants in the procedure and are not duplicated per country.
This country-level separation is illustrated by an example in guidance materials from the Scientific Centre for Expert Evaluation of Medicinal Products (FSBI «SCEEMP» of the Ministry of Health of Russia) on the mutual recognition procedure. An applicant chose the Republic of Kazakhstan as the reference State and submitted the initial version under sequence number 0000. After approval, the applicant filed with the States of Recognition, Russia and Armenia: each country received its own R.022 XML file with its own csdo:UnifiedCountryCode value and its own SubmissionSequence numbering, and the version numbers across the three states did not match and were not required to. A specialist who prepares a single combined file for all three states breaks the underlying logic of the R.022 structure.
The same happens with an error in the csdo:UnifiedCountryCode attribute or in SubmissionSequence numbering: the competent authority returns the submission with technical remarks, and the applicant re-files the corrected version under a new sequence number. Each cycle takes weeks and is especially costly close to a dossier alignment deadline.
Software for compiling and validating R.022 dossiers is already available on the Russian market — for example, «Vialek:OTD» and «EXON:OTD» — which build in the current schema from the EEC registry and suggest the document code from the Decision No. 159 classifier. A ready-made tool cuts the risk of manual XML tagging errors, particularly when filing with several member states at once.
| Parameter | Previous Practice | Current Standard |
|---|---|---|
| Dossier format | Paper CTD or scans without a unified XML schema | Electronic CTD structured under R.022 and R.017 |
| Paper duplication | Required even alongside electronic submission | Abolished by Decision No. 36 of 17 March 2022 |
| Document identification | At the applicant’s discretion | Mandatory code from the Decision No. 159 classifier |
| Country separation | Not formalized | csdo:UnifiedCountryCode attribute, one XML file per state |
| Version numbering | Not standardized | SubmissionSequence, 4 digits from 0000, tracked separately per state |
What to Do
Check the current version of the R.022 schema. Open the electronic document structures registry on the official Union website before building the XML file: the Commission updates the schema without changing the text of Decision No. 79.
Match every document code to the classifier. Use the current version of Decision No. 159 (as amended 25 June 2024) and assign each document a code strictly from the directory of structural elements, not a custom label.
Split Module 1 by member state. Build a separate R.022 XML file for the reference State and for each State of Recognition, using the csdo:UnifiedCountryCode attribute.
Keep SubmissionSequence numbering separate per country. Do not carry a sequence number from one state over to another unless filings go out at the same time.
Check your status against the 31 December 2025 deadline. That date has passed: if a dossier alignment application was filed before it, the national marketing authorization stays extended for the length of the procedure — up to 3 years in the reference State and up to 2 years in each State of Recognition — and every later version of the dossier still has to be built in the R.022 structure. If no application was filed, check the terms under Decision No. 34 of 22 May 2025 and the Russian Ministry of Health’s explanatory letter of 9 October 2025 (No. 25-6/И/2-20325) before preparing an XML file.
Companies that check the R.022 schema version in the EEC registry and the Decision No. 159 classifier codes before every submission pass technical validation on the first attempt. Those still working from FDA or EMA guidance lose weeks fixing rejections and risk missing the dossier alignment deadline.
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. 36 of 17 March 2022, «On Amendments to Decision No. 78 of the Council of the Eurasian Economic Commission of 3 November 2016»
3. Board of the EEC Decision No. 79 of 30 June 2017, «On Requirements for the Electronic Form of Applications and Registration Dossier Documents Submitted in the Registration and Examination of Medicinal Products for Human Use» (as amended 19 April 2022)
4. Board of the EEC Decision No. 159 of 17 September 2019, «On the Classifier of Document Types of the Medicinal Product Registration Dossier and the Directory of Structural Elements of the Medicinal Product Registration Dossier» (as amended 25 June 2024)
5. 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»
6. Letter of the Ministry of Health of Russia No. 25-6/И/2-20325 of 9 October 2025, «On the Submission of Applications for Aligning Medicinal Product Registration Dossiers with the Requirements of International Treaties and Acts Constituting EAEU Law» (explanatory letter, not a normative act)