The EAEU Pharmacopoeia Deadline Has Passed. Three Groups of Medicines and What Happens Next.
On January 1, 2026, the five-year transition period expired. From this date, Quality Specification Documents (QSDs) for all medicinal products (MPs) circulating on the EAEU market must comply with the requirements of the Pharmacopoeia of the Eurasian Economic Union. It would seem that five years was sufficient. However, the market was clearly not fully prepared for this deadline. Some manufacturers completed the update of registration dossiers well in advance, others worked in emergency mode until the final quarter of 2025, and some failed to make it in time at all.
Now, in mid-2026, we can already discuss where the industry actually stands. The EAEU Pharmacopoeia has ceased to be a document «about the future.» Today, it is a daily working reality. In this article, we will examine what has been included in its composition, how the post-deadline regime is structured for various groups of medicines, and what practical steps are currently relevant for regulatory affairs specialists.
From Concept to a Legally Binding Document
The idea of a unified pharmacopoeia did not originate in 2020. The legal framework was established in the Agreement on Unified Principles and Rules for the Circulation of Medicines within the EAEU dated December 23, 2014: Article 5 explicitly mandated the development of the Union’s pharmacopoeial requirements through the harmonisation of national monographs. In September 2015, the Board of the Eurasian Economic Commission (EEC) approved the Concept for Harmonising the Pharmacopoeias of the Member States (EEC Board Decision No. 119 dated 22.09.2015) and designated the methodological benchmark: the European Pharmacopoeia (Ph. Eur.).
The work spanned nearly five years. In August 2020, the EEC Board approved the first volume of the first edition of the EAEU Pharmacopoeia (EEC Board Decision No. 100 dated 11.08.2020, hereinafter Decision No. 100). On March 1, 2021, the first part of this volume entered into force, comprising 157 general pharmacopoeial monographs (GPMs) covering analytical methods, reagent requirements, sterility testing, and biological and microbiological methods.
The composition of the Pharmacopoeia expanded systematically. In October 2022, a second package of GPMs was introduced (EEC Board Decision No. 150 dated 25.10.2022, hereinafter Decision No. 150), which refined and supplemented the first volume and specified requirements applicable to veterinary medicinal products. In June 2024, the EEC Board adopted Decision No. 75 dated 25.06.2024, introducing further amendments to Decision No. 100: new GPMs were brought into effect on January 1, 2025, with the Decision itself entering into force on December 25, 2024. The expansion also encompassed monographs on biological and radiopharmaceutical medicines.
One fundamental point must be emphasised: the EAEU Pharmacopoeia is a document of direct application. EEC acts take precedence over national legislation governing the circulation of medicines. This means that a Russian manufacturer cannot cite the State Pharmacopoeia of the Russian Federation, 15th Edition (SP RF XV), as a sufficient basis if their product is circulating within the EAEU and the QSD has not been brought into conformity with Union requirements.
Structure of the First Volume
The first volume of the EAEU Pharmacopoeia contains no monographs on specific medicinal products or active substances. It consists entirely of general monographs, forming the methodological foundation for work with the individual monographs of the second volume.
| Section | Content | Practical Significance |
|---|---|---|
| 1 | General Notices, status of requirements | Mandatory, advisory, and informative requirements |
| 2.1 | Apparatus and physicochemical methods | Spectroscopy, chromatography, thermal analysis |
| 2.2 | Reagents and reference standards | EAEU CRS, admissibility of Ph. Eur. CRS |
| 2.3 | Biological and microbiological methods | Sterility, pyrogenicity, microbiological purity |
| 4 | Dosage forms | General requirements for tablets, injectables, creams, etc. |
All methods included in the monographs are considered validated by default. This does not, however, exempt the manufacturer from verifying the procedure under the specific conditions of their own laboratory. If a company employs an alternative method, it must demonstrate its comparability with the official one. In practice, this requirement is frequently underestimated.
The Pharmacopoeia permits the use of both EAEU certified reference standards (CRS) and, in certain cases, Ph. Eur. CRS. For manufacturers working with imported active substances or exporting products, this represents a significant practical concession.
What Has Changed After January 1, 2026
The deadline has passed. As early as January 29, 2026, the Ministry of Health of the Russian Federation issued clarifications in Letter No. 25-6/894, addressing the situation of medicinal products that found themselves in various regulatory positions by that date. The document divides all MPs into three groups.
Group One. Products for which an application for alignment was submitted before December 31, 2025, but the procedure has not yet been completed. For these, the validity of marketing authorisations (MAs) is extended automatically for the duration of the procedure, but for no more than 3 years in each of the concerned member states from the date of submission to the reference state, plus an additional maximum of 2 years in the member states of recognition. Their status in the register remains «Active.»
Group Two. Products that have already completed the alignment process. For these, manufacturing is permitted for 180 calendar days under the old national MA from the date the procedure is completed. Thereafter, the MA is granted «EAEU» status in the state register.
Group Three. Products for which no application was submitted by December 31, 2025. Circulation of such MPs is permitted only until the end of their shelf life, and strictly on the condition that they were manufactured before the expiry of the MA and released into circulation in the established manner.
Additionally, Government Decree No. 2202 dated December 29, 2025, amended Government Decree No. 353 dated March 12, 2022 «On the Specifics of Permitting Activities in the Russian Federation,» providing for the extension of MAs of Group Three products until January 1, 2027, provided they were placed into circulation for at least three calendar years as of December 1, 2025. This is an exception, not the rule: manufacturing under such an MA will still cease as soon as its validity expires or the year 2027 begins.
Two Standards in Parallel
Two sets of pharmacopoeial requirements coexist on the Russian market simultaneously, and manufacturers must comply with both.
| Parameter | EAEU Pharmacopoeia | SP RF XV |
|---|---|---|
| Legal basis | EEC Board Decision No. 100 (2020, as amended 2024) | Orders of the Ministry of Health of the Russian Federation |
| Status in the RF | Directly applicable EAEU act | National standard |
| Harmonisation basis | European Pharmacopoeia (Ph. Eur.) | National traditions + EAEU Pharmacopoeia |
| Dossier alignment deadline | January 1, 2026 | September 1, 2026 |
| Scope | Human and veterinary medicinal products | Human medicinal products |
For a manufacturer operating on the EAEU market, the earlier deadline — January 1, 2026 — is the operative reference point. The SP RF XV remains mandatory for products registered solely under the national procedure and not extending beyond the Russian market. Order of the Ministry of Health No. 468n dated September 13, 2024, updated the procedure for developing SP RF monographs: it established that national GPMs and individual pharmacopoeial monographs must be developed with the EAEU Pharmacopoeia as a mandatory reference. The two standards are moving toward one another. Discrepancies will gradually diminish.
Veterinary Sector Granted an Extra Three Years
For veterinary medicinal products, the transition period took a different course from human medicines. In February 2026, the Council of the EEC adopted Decision No. 33 dated 24.02.2026, amending Decision of the Council of the EEC No. 1 dated 21.01.2022 «On the Rules for Regulating the Circulation of Veterinary Medicines on the EAEU Customs Territory.» The transitional deadlines were shifted from 2027 to 2030.
Until December 31, 2030:
manufacturers may register veterinary products under national rules;
marketing authorisations issued prior to the introduction of unified rules remain valid;
companies must bring the dossiers of previously registered veterinary products into conformity with EAEU requirements.
If the marketing authorisation holder fails to submit an alignment application within the established timeframe, extended or indefinite registrations will be declared invalid as of January 1, 2031 — previously this date stood at January 1, 2028. The industry has gained three additional years, and these appear to be the final deadlines.
The Unresolved Issue of the Second Volume
The entire system operates with a significant gap: the second volume of the EAEU Pharmacopoeia, which is intended to contain individual monographs for specific active substances and dosage forms, is still under development.
What does this mean in practice? In the absence of an individual EAEU monograph for a specific substance or product, the manufacturer must rely on a national standard or a Ph. Eur. monograph. This creates non-uniformity: different manufacturers of the same International Nonproprietary Name (INN) apply different quality control standards, and expert organisations of member states apply them differently.
The practical approach adopted across the industry: in the absence of an individual EAEU monograph, apply the most stringent available standard — typically Ph. Eur. or SP RF XV. This reduces regulatory risk, although it places an additional burden on the laboratory. Manufacturers operating simultaneously on the EAEU and EU markets are in a more advantageous position: their analytical methods are already built on Ph. Eur.
Action Plan
The experience of the first months post-deadline shows that work to align QSDs with the EAEU Pharmacopoeia did not end on January 1, 2026. It has shifted into a continuous maintenance mode.
Conduct an audit of QSD status across your entire portfolio. For each product, document whether the QSD has been aligned and whether the corresponding version has been accepted by the regulator. Divide the portfolio into three groups: compliance confirmed; amendment submitted and pending decision; issue unresolved.
Assess the risks for unresolved products immediately. If the QSD has not been aligned and no application was submitted by December 31, 2025, the product falls into Group Three under Ministry of Health Letter No. 25-6/894. Its circulation is limited to the shelf life of already manufactured batches. New production without a valid MA is not possible, except in cases qualifying for extension under Government Decree No. 2202. Clarify the specific situation with the competent authority.
Set up internal monitoring for EAEU Pharmacopoeia updates. The Pharmacopoeia Committee continues its work and new GPMs are published regularly — the latest package entered into force on January 1, 2025. The version of the Pharmacopoeia current at the time of submitting a dossier variation must match the version applied in the laboratory.
Verify certified reference standards. If your company uses Ph. Eur. CRS where EAEU CRS already exist, transition to the latter. During GMP inspections, CRS status is frequently the first point of contention.
Formulate a plan for veterinary products through 2030. Council of the EEC Decision No. 33 gives the industry until December 31, 2030, but that is no reason to postpone action. Aligning veterinary product dossiers with EAEU requirements is an extensive undertaking, and starting early will help avoid queues at expert organisations ahead of the new deadline.
The EAEU Pharmacopoeia is not a one-time regulatory event that can be completed and set aside. It is a living document: it is updated, expanded, and its relationship with national standards evolves as new GPMs are released and the second volume with individual monographs draws closer. Monitoring these changes is now a standing requirement of the regulatory function in any pharmaceutical company.
Regulatory Framework:
1. EEC Board Decision No. 100 dated 11.08.2020 «On the Pharmacopoeia of the Eurasian Economic Union» (as amended 25.06.2024)
2. EEC Board Decision No. 150 dated 25.10.2022 «On Amending EEC Board Decision No. 100 dated August 11, 2020»
3. EEC Board Decision No. 75 dated 25.06.2024 «On Amending EEC Board Decision No. 100 dated August 11, 2020»
4. EEC Board Decision No. 119 dated 22.09.2015 «On the Concept for Harmonising the Pharmacopoeias of the EAEU Member States»
5. Agreement on Unified Principles and Rules for the Circulation of Medicines within the EAEU dated 23.12.2014
6. Decision of the Council of the EEC No. 33 dated 24.02.2026 «On Amending Decision of the Council of the EEC No. 1 dated January 21, 2022»
7. Letter of the Ministry of Health of the Russian Federation No. 25-6/894 dated 29.01.2026 (Department for Regulation of the Circulation of Medicines and Medical Devices)
8. Decree of the Government of the Russian Federation No. 2202 dated 29.12.2025 «On Amending Certain Acts of the Government of the Russian Federation»
10. Decree of the Government of the Russian Federation No. 353 dated 12.03.2022 «On the Specifics of Permitting Activities in the Russian Federation» (as amended 2025)
11. Order of the Ministry of Health of the Russian Federation No. 468n dated 13.09.2024 «On Approving the Procedure for the Development of General Pharmacopoeial Monographs and Individual Pharmacopoeial Monographs…»
12. Federal Law No. 61-FZ dated 12.04.2010 «On the Circulation of Medicines» (as amended 2025)