EAEU GMP Certificates Now Follow a Single Standard. What Changed with EEC Recommendation No. 13
Kazakh manufacturer obtains an EAEU GMP (Good Manufacturing Practice) certificate at home, submits a registration dossier to Russia, and receives a deficiency notice regarding the certificate itself. The manufacturing site is compliant, the documents are complete — but the registration stalls because the certificate number is formatted differently from what the Russian expert expects. Formally one system, in practice five different approaches.
It was precisely to address this situation that the Board of the Eurasian Economic Commission (EEC) adopted Recommendation No. 13 in June 2024 — the Guideline on Filling Out the Certificate of Conformity of Production with the Requirements of the GMP Rules of the Eurasian Economic Union (EAEU). Since June 28, 2024, the authorized bodies of all five member states have had a single instructional document. Here is what this has changed in practice and how to work with the new requirements.
Where the Discrepancy Problem Came From
EAEU GMP Rules have been in effect since November 2016. They were approved by EEC Council Decision No. 77 dated November 3, 2016 (hereinafter — the GMP Rules). The procedure for conducting pharmaceutical inspections is established in EEC Council Decision No. 83 dated November 3, 2016 (hereinafter — Decision No. 83), with the latest revision dated August 1, 2025. Both documents set requirements for the inspection process and the certificate form, but neither provided detailed instructions on how to fill them out.
As a result, each member state interpreted the requirements independently. Russian certificates differed from Belarusian ones, and Kazakh certificates differed from Kyrgyz ones. A drug registration specialist receiving a certificate from another EAEU country often could not make sense of it without follow-up inquiries: to what extent the site was inspected, which specific operations were covered, and when the document’s validity period expired.
Two questions caused the most friction. First: how to format the certificate number and what information should be encoded in it. Second: which manufacturing operations to list in the annex to the certificate, and with what level of detail. Complaints came from both sides — manufacturers objected to deficiencies raised against correctly issued documents, while experts lamented the impossibility of quickly comparing certificates from different countries.
Another source of friction was the lack of a unified method for verifying authenticity. Some countries included a link to a database in the certificate text; others did not do so at all. Customs authorities and regulators in neighboring member states found themselves in situations where confirming the legitimacy of a document required manual inquiries.
What EEC Board Recommendation No. 13 Established
Recommendation of the EEC Board No. 13 dated June 25, 2024 «On the Guideline on Filling Out the Certificate of Conformity of Production with the Requirements of the Good Manufacturing Practice Rules of the Eurasian Economic Union» (hereinafter — Recommendation No. 13) entered into force on June 28, 2024.
The document is advisory in nature, and member states adopt it voluntarily. In practice, authorized bodies have no real reason to deviate from it: EEC Recommendations are addressed specifically to regulators, and the document’s adoption means new certificates are issued to a single template. Certificates issued before June 28, 2024, continue to be valid in their previous format until their expiration date. Here are the specific requirements.
Unified Format of the Certificate Number
Perhaps the most tangible change is the standardized registration number. It now follows the formula:
N GMP/EAEU/ZZ/000XX-20XX
What each block means:
GMP: designation of the Good Manufacturing Practice domain
EAEU: territory of validity — the Eurasian Economic Union
ZZ: two-letter member state code per ISO 3166-1-2013 «Codes for the representation of names of countries and their subdivisions» (AM for Armenia, BY for Belarus, KZ for Kazakhstan, KG for Kyrgyzstan, RU for Russia)
000XX: five-digit sequential number from the pharmaceutical inspections database
20XX: year of certificate issuance
A slash («/») is placed between the blocks. This may seem like a technicality. For databases and verification systems, however, it is critical: the unified format allows instant identification of the issuing country, the year, and the serial number without manual parsing.
The certificate is a controlled document. The blank form is produced by a printing house with security features established by the legislation of the respective member state. The blank serial number and the certificate registration number are separate fields, each filled in independently.
How the Validity Period Is Calculated
Prior to Recommendation No. 13, the validity period was calculated inconsistently across countries. The rule is now unambiguous: the period runs from the last day of the most recent inspection plus a period determined by risk analysis. The maximum is 3 years.
An example from the Guideline: validity period from July 1, 2022 to June 30, 2025. If the inspection was conducted in multiple stages with intervals, all dates are listed separated by commas in the corresponding field of the certificate.
For manufacturers, this means being able to plan the next inspection well in advance. With a clear expiration date on the certificate, the regulatory affairs team builds a preparation schedule ahead of time, without last-minute follow-up requests.
Verification of Authenticity via the Registry
Each certificate must now indicate the path to a database for authenticity verification: the full name of the authorized body and a link to the registry. For Belarusian certificates, for example, this is the registry of the Ministry of Health of the Republic of Belarus.
Recommendation No. 13 also anticipates a future scenario: once the unified EAEU pharmaceutical inspections database becomes operational, certificates will reference it via the Commission’s website. Until that database is launched, each certificate references the national registry of the authorized body of the issuing member state.
Certificate Languages
The certificate is completed in Russian. If the legislation of a member state requires documentation in the state language, the certificate is issued on a double-sided form, with each side corresponding to one of the languages. This applies to Kazakhstan and Kyrgyzstan. The Russian-language side is always retained.
How the Detailing of Manufacturing Operations Changed
The most detailed and practically relevant section of Guideline No. 13 covers the classification of manufacturing operations on the certificate’s additional sheet. Before 2024, sites often received certificates with generalized wording such as «manufacture of finished dosage forms.» When submitting a registration dossier in another country, this created uncertainty: did the inspection cover a specific operation, or only part of the production cycle?
The structure is now detailed.
| Certificate block | What is included |
|---|---|
| Sterile products (1.1) | Large volume liquids, small volume liquids, lyophilizates, solid forms and implants, semi-solid forms, other products manufactured under aseptic conditions |
| Non-sterile products (1.2) | Tablets, capsules, oral solutions, semi-solid forms (ointments, creams, gels), other non-sterile dosage forms |
| Manufacturing operations | Dosage form preparation, primary packaging, secondary packaging, quality control, batch release |
Only those sections and subsections for which an inspection was actually conducted are included in the additional sheet. If a site was not inspected for batch release, that operation does not appear in the certificate — and the certificate cannot be cited when registering products that require it. A vague formulation in the certificate no longer provides a false safety net.
For contract sterilization arrangements, the Guideline includes a specific note. If a site produces a non-sterile intermediate and outsources terminal sterilization to another site under contract, this must be recorded in the «Constraints or explanatory notes» field. Leaving this field blank when contract sterilization is actually taking place is a direct documentation error.
Before and After in One Table
| Parameter | Before June 2024 | After June 2024 |
|---|---|---|
| Number format | Arbitrary, different for each country | GMP/EAEU/ZZ/000XX-20XX |
| Validity period | Applied inconsistently | From last inspection plus risk analysis, maximum 3 years |
| Authenticity verification | At the discretion of the authority | Mandatory link to the registry |
| List of operations | Often generalized wording | Only actually inspected operations, with detail |
| Languages | Varied | Russian plus state language where required |
What to Do
The Recommendation is directed at authorized bodies, but manufacturers’ regulatory teams have concrete steps to take right now.
Check the validity periods of all active GMP certificates. Establish when each one expires. Sites whose certificates expire in 2025–2026 are already receiving, or will soon receive, reissued certificates in the new format — confirm in advance that the authority is working according to Guideline No. 13.
When receiving a new certificate, review the additional sheet immediately. Every manufacturing operation needed for your portfolio must be listed. If the site produces both sterile and non-sterile forms, both blocks must be present. Batch release is a separate operation: it must be inspected and written into the certificate if you intend to rely on it during drug registration.
Verify counterparty certificates from other EAEU countries via the registry before submitting the dossier. The mandatory registry link provides a standard verification method. Using it reduces the risk of deficiencies during the expert review stage.
Before a scheduled inspection, compile a list of operations that must appear in the certificate. Inspectors only cover declared operations. The right to batch release does not arise automatically — it must be declared, and the site and documentation must be prepared accordingly.
Cross-check the site address in the manufacturing license against what will be written in the certificate. Guideline No. 13 requires an exact match with the address in the special manufacturing authorization. A discrepancy creates a formal ground for questions during registration — and fixing it mid-process is far more costly.
Recommendation No. 13 does not resolve all the problems of mutual GMP recognition in the EAEU. Inspection frequency, tariffs, and the interpretation of deviations are all governed separately. But it has closed a specific gap: a certificate from any member state now reads the same way everywhere. This reduces administrative friction during registration and gives manufacturers a clear baseline when preparing for an inspection.
Regulatory framework:
1. Recommendation of the EEC Board No. 13 dated June 25, 2024 «On the Guideline on Filling Out the Certificate of Conformity of Production with the Requirements of the Good Manufacturing Practice Rules of the Eurasian Economic Union»
2. EEC Council Decision No. 77 dated November 3, 2016 «On Approval of the Good Manufacturing Practice Rules of the Eurasian Economic Union»
3. EEC Council Decision No. 83 (as amended on August 1, 2025) «On Approval of the Rules for Conducting Pharmaceutical Inspections»
4. International Standard ISO 3166-1-2013 «Codes for the representation of names of countries and their subdivisions. Part 1»