Module 3 of the EAEU Drug Registration Dossier Determines the Quality of the Substance and Finished Product
A regulatory affairs manager opens a brief prepared by colleagues and finds a reference to «Eurasian Economic Commission (EEC) Decision No. 79» as the basis for the electronic dossier requirements. Six months later, during the regulatory review stage, it turns out the reference actually meant a completely different Decision No. 79, one governing pharmacovigilance, and the act actually needed was adopted by a different body of the Commission and in a different year. Numbers assigned by the Council and the Board of the EEC overlap, and confusing these digits costs companies weeks of dossier corrections.
Module 3 of the Common Technical Document rests on several dozen such decisions and annexes. It is larger than the other modules, and it is precisely where applicants filing for registration under the rules of the Eurasian Economic Union (EAEU, «the Union») for the first time stumble most often. Here is its section-by-section structure, and which regulatory references are worth double-checking first in project work.
Where the 3.2.S and 3.2.P Structure Came From
Before the transition to unified rules, pharmaceutical companies prepared dossiers under the individual national requirements of each CIS country, and the structure of the quality section varied from state to state. EEC Council Decision No. 78 of 3 November 2016, «On the Rules for Registration and Examination of Medicinal Products for Human Use,» introduced the Common Technical Document (CTD) format across the whole Union and established a single structure of five modules.
Detailed requirements for the content of each module are set out in a separate document, Annex No. 1 to these Rules. It lays out the structure of Section 3 «Quality»: subsection 3.2.S for the pharmaceutical substance, 3.2.P for the finished product, 3.2.A for appendices, and 3.2.R for regional information. Since 1 July 2021 (1 January 2021 in Russia), submitting new applications under national procedures in Union member states is no longer permitted. Existing national registration certificates go through dossier alignment with Union requirements under Section XIII of the same Rules.
Section 3.2.S, the Pharmaceutical Substance
Section 3.2.S covers the active substance separately from the finished product and splits into seven subsections.
3.2.S.1 covers nomenclature: the international nonproprietary name (INN), the compendial name, the structural formula, and the molecular weight, plus the amino acid sequence for biotechnological substances. 3.2.S.2 covers the manufacturing process, including starting materials, control of critical steps, and, for biological substances, cell bank data and viral safety. 3.2.S.3 covers substance characterization and impurities, confirmed by modern physicochemical methods.
3.2.S.4 sets the specification and batch release testing methods. 3.2.S.5 covers reference standards. 3.2.S.6 covers the substance’s primary packaging. Closing out the section is 3.2.S.7 «Stability,» which presents the testing program and the applicant’s post-authorization stability commitments.
Annex No. 1 separately provides that for substances with a confirmed ten years of medicinal use in at least three member states, an applicant may submit a shortened dossier, or an Active Substance Master File (ASMF), instead of the full 3.2.S data package. The manufacturer may submit such a master file’s closed part directly to the competent authority, without disclosing it to the applicant.
For vaccines and blood-derived products, Section 3.2.S works differently. Instead of a full substance dossier, the applicant submits a vaccine antigen master file or a plasma master file. The holder of such a document for a vaccine can only be the registration holder itself. The ASMF procedure does not apply to biological substances at all. Characterizing their properties needs a combination of physicochemical and biological methods, together with deep knowledge of the manufacturing process and its controls at every stage.
Section 3.2.P, the Finished Product
Section 3.2.P opens with the composition description (3.2.P.1): all components, their quantity per dose unit, and their function, including excipients regardless of their share in the formulation. 3.2.P.2 «Pharmaceutical Development» explains why this particular composition, technology, and packaging were chosen, and since 22 January 2025 this subsection has also covered administration devices (pen injectors, dispensers, auto-injectors) when they are included with the product.
3.2.P.3 covers the manufacturing process and control of critical steps. 3.2.P.4 covers the quality of excipients, including the requirement for colorants to comply with Technical Regulation TR CU 029/2012. 3.2.P.5 «Control of the Medicinal Product» sets release and shelf-life specifications, along with an allowed active substance content deviation of no more than 5% at the date of batch manufacture, unless otherwise justified.
3.2.P.6 and 3.2.P.7 mirror the logic of S.5 and S.6 for the finished product: reference standards and the container closure system. Section 3.2.P closes with 3.2.P.8 «Stability of the Medicinal Product,» and for products with an administration device, this also includes functional testing of the device itself over the shelf life.
| Section | Content | Key subsections |
|---|---|---|
| 3.2.S | Active pharmaceutical substance | S.1 nomenclature, S.2 manufacture, S.3 characterization and impurities, S.4 quality control, S.7 stability |
| 3.2.P | Finished medicinal product | P.1 composition, P.2 pharmaceutical development, P.3 manufacture, P.5 quality control, P.8 stability |
| 3.2.A | Appendices | Manufacturing facilities, adventitious agent safety evaluation, novel excipients |
| 3.2.R | Regional information | Process validation scheme (R.2), information on medical devices in the pack (R.6) |
How an Assessor Reviews Module 3
The quality assessment report form, approved by Annex No. 8 to the Rules, mirrors the structure of Module 3 subsection by subsection. The assessor completes the substance subsections (3.1 through 3.7 of the report, corresponding to 3.2.S.1 through 3.2.S.7 of the dossier) and the product subsections (4.1 through 4.8, corresponding to 3.2.P.1 through 3.2.P.8), in the same order as the applicant, and leaves an «Assessor’s Comment» field after every subsection.
The assessor sorts issues into two tiers. A critical deficiency means the submitted data does not confirm the product’s quality or efficacy, or points to an unacceptable benefit-risk balance. A minor deficiency records a deviation from requirements that does not put patient health at risk. Section 9 of the report rolls up deficiencies by tier, separately for the substance and for the product; Section 8 holds the assessor’s overall conclusion on quality.
For a substance supplied under the master file system (ASMF), the assessor prepares a separate report on the closed part, which is never shared with the applicant under any circumstances: queries on that part go directly to the master file holder, bypassing the applicant. If a draft contains wording like «the assessor will forward remarks on the ASMF closed part to the applicant,» that is an error to catch before the text goes to editing.
The full composition table (Form P.1-1, from the same Annex No. 8) requires a dedicated column linking each component to the normative quality document. This is further confirmation that the data in Module 3.2.P.1 and the text of the normative document must match, literally.
Appendices and Regional Information, Without Redundant Documents
Section 3.2.A covers three areas: descriptions of manufacturing facilities and equipment, the adventitious agent safety evaluation, and a full dossier for any novel excipient used in pharmaceutical practice for the first time.
Section 3.2.R needs care. It originally held five subsections. EEC Council Decision No. 36 of 17 March 2022 removed subsections 3.2.R.1 and 3.2.R.3 through 3.2.R.5 as redundant. The current version of Annex No. 1 now leaves only the process validation scheme (3.2.R.2) and, since 22 January 2025, information on medical devices and components included in the pack (3.2.R.6). The normative quality document, GMP inspection records, and post-authorization stability commitments no longer belong in 3.2.R; they sit in other sections of the dossier, which is worth keeping in mind when structuring the file set.
The Normative Quality Document and Where It Belongs
The normative document consolidates the specification and test methods into a format a quality control laboratory can act on, and it becomes part of the registration certificate alongside the Summary of Product Characteristics and the package leaflet. It is drawn up under a separate act, EEC Board Decision No. 151 of 7 September 2018, «On Approving the Guideline for Compiling the Normative Quality Document for a Medicinal Product.» Draft materials sometimes place its filing incorrectly, in Section 3.2.R. The normative document is filed in Module 1 of the registration dossier, item 1.5.7 of Annex No. 1.
The normative document text must match the data in Section 3.2.P.5, literally. Module 3 may list one chromatographic method, while the normative document, drawn up separately by a different specialist at a later stage, lists different column parameters. The normative document is a binding standard for state laboratories, so any discrepancy has to be resolved before the registration certificate is granted.
Stability Studies and Climatic Zones, Without the Myths
Decision No. 78 only sets out the dossier structure. Stability testing requirements come from a separate EEC Board act, Decision No. 69 of 10 May 2018, «On Approving the Requirements for Stability Testing of Medicinal Products and Pharmaceutical Substances,» as amended by Decision No. 86 of 30 June 2020. It introduces climatic zones and sets storage conditions for testing based on the zone a product is intended for.
The baseline long-term testing conditions, applicable to most Union member states, are 25°C and 60% relative humidity for a minimum of 12 months. Alternative conditions of 30°C/65% (or 30°C/75%) apply if the product is intended for marketing in climatic zones III and IV, as set out in the annex to the same Decision. Intermediate testing runs at 30°C/65% for 6 months, and accelerated testing at 40°C/75%, also for 6 months.
| Test type | Conditions | Minimum duration at submission |
|---|---|---|
| Long-term | 25°C / 60% (or 30°C/65% and 30°C/75% for Zones III–IV) | 12 months |
| Intermediate | 30°C / 65% | 6 months |
| Accelerated | 40°C / 75% | 6 months |
For products requiring refrigeration, long-term testing runs at 5±3°C; for frozen storage, at -20±5°C. Stability testing requirements for biological medicinal products are set out separately, in the Union Rules for Conducting Studies of Biological Medicinal Products.
Actionable Steps
Check every reference to «Decision No. 79» before filing. EEC Council Decision No. 79 of 3 November 2016 governs pharmacovigilance (GVP). Requirements for the electronic format of registration dossier applications and documents come from a different act, EEC Board Decision No. 79 of 30 June 2017. Overlapping numbers across different issuing bodies come up more than once in Union practice, so always state whether a decision came from the Council or the Board when citing it.
Check Section 3.2.R against the current version of Annex No. 1. If a draft or a brief lists five subsections (R.1 through R.5), update it: since 2022 only R.2 remains, plus R.6 since 2025.
Reconcile the normative document against Module 3.2.P.5 line by line. Before filing, align the analytical method, column parameters, and acceptance criteria in both documents, so an assessor’s query doesn’t arrive at a stage where fixing it costs weeks.
Determine the product’s target climatic zone before starting stability studies. The choice between 25°C/60% and 30°C/65% sets the length and cost of the program, and changing conditions midway means restarting the study.
Build the transition to the ICH M4Q(R2) structure into the dossier roadmap. The guideline reached Step 2 in May 2025, public consultation closed in October of the same year, and final adoption is not expected before 2027. There is time to prepare. It is worth building the habit of keeping Module 3 data in a structured format starting now.
Behind every subsection of Module 3 stands a separate Commission act with its own number, date, and issuing body, and confusing them costs companies more than preparing the data itself. Checking regulatory references before filing takes hours. Fixing a dossier after an assessor’s deficiency notice takes weeks.
Regulatory Framework:
1. EEC Council Decision No. 78 of 3 November 2016 (as amended 26 November 2025), «On the Rules for Registration and Examination of Medicinal Products for Human Use,» including Annex No. 1
2. EEC Council Decision No. 34 of 22 May 2025, «On Amending Decision No. 78»
3. EEC Council Decision No. 36 of 17 March 2022, «On Amending Decision No. 78» (removal of subsections 3.2.R.1, 3.2.R.3-3.2.R.5)
4. EEC Board Decision No. 69 of 10 May 2018 (as amended by Decision No. 86 of 30 June 2020), «On Approving the Requirements for Stability Testing of Medicinal Products and Pharmaceutical Substances»
5. EEC Board Decision No. 151 of 7 September 2018, «On Approving the Guideline for Compiling the Normative Quality Document for a Medicinal Product»
6. EEC Board Decision No. 79 of 30 June 2017, «On Requirements for the Electronic Format of Applications and Dossier Documents Submitted for the Registration and Examination of Medicinal Products for Human Use»
7. EEC Board Decision No. 159 of 17 September 2019, «On the Classifier of Document Types in the Medicinal Product Registration Dossier and the Directory of Structural Elements of the Medicinal Product Registration Dossier»