Mismatched site addresses across Module 1 documents remain the top cause of EAEU dossier delays
A dossier is rejected most often not because of clinical data or active substance specifications. The application references one manufacturing site, the manufacturing license lists another, and the normative quality document mentions a third. All three documents reside in Module 1, and an assessor detects this discrepancy within ten minutes of reviewing the dossier.
Module 1 is not part of the harmonized core of the Common Technical Document (CTD). Modules 2 through 5 are identical across all regulatory systems operating under this format. Module 1 compiles administrative and legal documentation specific exclusively to the Eurasian Economic Union (EAEU), and it is precisely where foreign applicants with prior experience in FDA or EMA submissions stumble most frequently.
The Administrative Section Before the Union Rules
Prior to 2021, a manufacturer planning distribution across several Union countries had to prepare a distinct administrative package tailored to each national procedure. Application forms, lists of accompanying documents, and packaging layout requirements differed across Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan. There was no unified register of medicinal products, and a Marketing Authorisation Holder (MAH) had no certainty that an instruction approved in one country would satisfy an assessor in another.
Since 1 January 2021, applicants submit new registration dossiers exclusively under the EAEU rules approved by EEC Council Decision No. 78 of 3 November 2016, «On the Rules for Registration and Examination of Medicinal Products for Human Use» (hereinafter referred to as Rules No. 78). A transitional period applied to products already marketed under national procedures. EEC Council Decision No. 34 of 22 May 2025 set a hard deadline for submitting applications to bring registration dossiers into dossier alignment with Union requirements: 31 December 2025. For MAHs who submitted an application before this date, the marketing authorisation validity is extended for the duration of the procedure: up to 3 years in the Reference Member State and up to an additional 2 years in each State of Recognition. For everyone who missed the deadline, simplified alignment is no longer available, and the dossier must be compiled from scratch according to the full requirements of Module 1.
Structure of Module 1 Today
Annex No. 1 to Rules No. 78, «Requirements for Documents of the Registration Dossier (in the Common Technical Document Format),» establishes the structure of Module 1, while Annex No. 4 to the same Rules sets out the consolidated document inventory. The current version reflects amendments as of 26 November 2025 (EEC Council Decision No. 93), which, among other items, clarified requirements for the Risk Management Plan.
The section comprises eleven blocks rather than the five or six typical of European notation familiar to professionals experienced with EMA regulations. Confusing these two numbering systems is perhaps the most frequent error in briefs and drafts based on Western analogues.
| Section | Content |
|---|---|
| 1.0 | Cover letter for the application |
| 1.1 | Table of contents for Modules 1–5 |
| 1.2 | General documentation: application form, proof of fee payment, WHO certificate, scientific advice outcomes |
| 1.3 | Summary of Product Characteristics (SmPC), Patient Information Leaflet (package leaflet), packaging mock-ups |
| 1.4 | Regulatory status of the medicinal product in other countries |
| 1.5 | Quality documents, including the draft normative document |
| 1.6 | Manufacturing documents: GMP certificates, manufacturing license, inspection reports |
| 1.7 | Information on the experts who prepared the quality, non-clinical, and clinical overviews/summaries |
| 1.8 | Specific requirements for different application types (generic, hybrid, orphan, and others) |
| 1.9 | Environmental risk assessment |
| 1.10 | Applicant’s pharmacovigilance system |
| 1.11 | Copies of trademark registration documents |
For the dossier alignment procedure, certain documents are optional: inspection reports from 1.6.3 and 1.6.6, complaint records from 1.6.8, expert resumes from Section 1.7, and most of Section 1.8 may be omitted if the product is already marketed in a member state. For a new marketing authorisation application, all of the listed documents are required in full.
The Application, SmPC, and Normative Document Require the Most Cross-Checks
Section 1.2 begins with the application for marketing authorisation, formatted in accordance with Annex No. 2 to Rules No. 78. Composition, dosage form, strength, and manufacturing site addresses in the application must match the corresponding entries in the normative document and manufacturing license verbatim. Discrepancies in the spelling of site addresses, leading to dossiers being returned for remediation, occur regularly during regulatory assessment. The same section also includes the WHO-type certificate for the product, a document confirming its status in the country of manufacture, along with proof of payment of the registration fee.
Section 1.3 gathers the SmPC, package leaflet, and packaging mock-ups. EEC Council Decision No. 88 of 3 November 2016 (as amended on 21 February 2025) governs the content of the SmPC and leaflet. The 2025 revision modified Section 4.4 of the SmPC, «Special warnings and precautions for use»: it now requires the disclosure of excipients of known effect (allergens, preservatives, sugars) whenever their content exceeds established thresholds. For medicinal products derived from human blood or plasma, additional standardized warnings regarding the risk of transmitting infectious agents apply; these do not need to be drafted from scratch, as the exact wording is approved by Decision No. 88.
A dedicated act, EEC Council Decision No. 76 of 3 November 2016, «On Approving Requirements for Labeling of Medicinal Products for Human Use and Veterinary Medicinal Products,» governs the content of packaging labeling. The applicant submits the packaging mock-ups themselves in accordance with the requirements of Rules No. 78. Certain products also require user testing results of the package leaflet (readability test), confirming that patients can find and properly understand key information.
The normative quality document (ND) is not prepared under Module 3, as might be assumed by analogy with FDA or EMA dossiers, but is incorporated into Module 1 as a standalone item: 1.5.7. Annex No. 3 to Rules No. 78 specifies its structural requirements, while EEC Board Decision No. 151 of 7 September 2018 approves the detailed methodological guidance. The ND consists of eight sections: title page, qualitative and quantitative composition, specification, analytical procedures, packaging, labeling (referencing section 1.3.2 of Module 1), storage conditions, and shelf life.
Pharmacovigilance is allocated to Section 1.10: the Pharmacovigilance System Master File (PSMF) of the MAH (or its summary if the holder has previously submitted applications), written confirmation of the availability of a Qualified Person for Pharmacovigilance (QPPV), and the Risk Management Plan (RMP). Decision No. 93 appended the qualifying clause «if applicable» to the RMP requirement: the document is no longer mandatory for every single dossier, but only when warranted by the safety profile of the specific medicinal product.
Actionable Steps
Reconcile administrative data across all module documents. Take the application form, SmPC, packaging mock-ups, normative document, and manufacturing license, and perform a line-by-line comparison of the product name, composition, strength, and manufacturing site addresses. Correct any discrepancy before submission rather than after receiving an official deficiency notice.
Verify GMP certificate coverage for every site. The manufacturing chain encompasses the drug substance manufacturer, the finished dosage form facility, and the batch release quality control site. For sites located outside the Union, provide a valid copy of the GMP certificate or a direct reference to the competent authority’s official register (e.g., EudraGMP).
Update the SmPC and package leaflet to the latest revision of Decision No. 88. Review Section 4.4 for excipients requiring explicit mention, and confirm that packaging mock-ups adhere to Decision No. 76. For new pharmaceutical forms, compile a summary of the leaflet readability test.
Structure the normative document according to the eight mandatory sections. Reconcile the composition and specification against the data in Section 3.2.P.5.1 of Module 3 to prevent contradictions between Module 1 and Module 3 within the same dossier.
Determine the document scope based on the submission pathway. For a dossier alignment procedure, omit expert resumes and select inspection reports if the product is already authorized in a member state. For a new marketing authorisation, prepare the full dossier package, including a Risk Management Plan if applicable to the product’s safety profile.
Module 1 rarely causes a refusal of marketing authorisation on fundamental scientific grounds, but it routinely triggers requests for supplementary information and wasted weeks. A company that structures the administrative section of the dossier with the same rigor applied to the scientific modules secures a predictable review schedule instead of a continuous sequence of clarification requests.
Regulatory Framework:
1. EEC Council Decision No. 78 of 3 November 2016, «On the Rules for Registration and Examination of Medicinal Products for Human Use» (as amended on 26 November 2025), Annexes No. 1, No. 2, No. 3, No. 4
2. EEC Council Decision No. 34 of 22 May 2025, «On Amending EEC Council Decision No. 78 of 3 November 2016»
3. EEC Council Decision No. 93 of 26 November 2025, «On Amending the Rules for Registration and Examination of Medicinal Products for Human Use»
4. EEC Council Decision No. 88 of 3 November 2016, «On Approving Requirements for the Package Leaflet and the Summary of Product Characteristics for Medicinal Products for Human Use» (as amended on 21 February 2025, No. 18)
5. EEC Council Decision No. 76 of 3 November 2016, «On Approving Requirements for Labeling of Medicinal Products for Human Use and Veterinary Medicinal Products»
6. EEC Board Decision No. 151 of 7 September 2018, «Guideline for Compiling the Quality Normative Document for a Medicinal Product»