Russia’s veterinary pharmacovigilance rules changed in 2024. What MAHs must do before renewal
A company obtains a Marketing Authorization (MA) for a veterinary drug and assumes the hardest part of the work is behind them. This is a costly misconception. Failing to maintain post-marketing safety monitoring leads to the suspension of commercial circulation, the revocation of the MA, and fines during the registration renewal process. Post-market safety monitoring is just as much a part of a drug’s lifecycle as its initial registration. In Russian veterinary practice, this entire workflow runs through the federal information system «Galen,» and the compliance rules changed radically in 2024.
Below we break down how the system is structured, what regulators now demand from market participants, and how to organize internal operations to avoid a refusal when registration comes up for renewal in five years.
How Pharmacovigilance Operated Prior to 2024
Before the EAEU Rules came into full effect, every Marketing Authorization Holder (MAH) relied on Rosselkhoznadzor Order No. 9 dated January 11, 2018 («On Approval of the Procedure for Conducting Pharmacovigilance Regarding Medicinal Products for Veterinary Use», registered with the Ministry of Justice on March 28, 2018, under No. 50537; as amended October 7, 2020). The document established a framework for collecting adverse reaction data and submitting periodic reports, but requirements remained relatively lenient: specific periodic reporting deadlines were set on an individual basis, the role of an Authorized Person was not legally mandated, and compiling a Pharmacovigilance System Master File (PSMF) was not a mandatory requirement.
The «Galen» system existed during this era as a component of the Federal State Information System for Veterinary Medicine (VetIS). It aggregated adverse reaction reports and archived periodic submissions, but the analytical depth required for these files fell well short of what the EAEU later introduced.
As a result, many MAHs treated pharmacovigilance as a formality. Companies submitted minimal data, failed to establish internal safety protocols, and rarely designated a specialized employee to oversee the system.
What Changed on March 13, 2024
On this date, the pharmacovigilance section of EEC Council Decision No. 1 dated January 21, 2022 («On the Rules Regulating the Circulation of Veterinary Medicinal Products within the Customs Territory of the Eurasian Economic Union», hereinafter — the EAEU Rules, Decision No. 1) entered into force.
The EAEU Rules introduced an entirely new concept: the pharmacovigilance quality system. Periodic reporting is just one component of a continuously operating internal mechanism covering data collection, scientific evaluation, risk management, and documentation.
Key changes compared to the previous national regime:
| Parameter | National Regime (prior to March 13, 2024) | EAEU Regime (Decision No. 1) |
|---|---|---|
| Regulatory Framework | Domestic legislation of the member state | EEC Council Decision No. 1 |
| Master File (PSMF) | Not required | Mandatory |
| PSUR Submission Deadlines | Set individually | Strictly standardized |
| Authorized Person | Responsible employee (no formal standard) | QPPV with defined qualification requirements |
| Adverse Reaction Reporting | No fixed deadlines | Within 15 calendar days |
Decision No. 1 (as amended February 24, 2026) maintains a transitional period. Until December 31, 2030, registering drugs under domestic national legislation remains permissible. This applies to registration procedures only. Pharmacovigilance requirements have applied to all MAHs since March 13, 2024, regardless of which rules the drug was originally registered under.
Inside the Galen System
Galen is a specialized component of VetIS through which Rosselkhoznadzor conducts post-market surveillance of veterinary products. When the system is unavailable, direct contact with the regulator is maintained via galen@fsvps.ru.
MAHs have access to three working sections within the portal.
The «My Medicinal Products» section displays the regulatory status of each MA and the list of calculated monitoring periods. The system automatically computes PSUR due dates based on the drug’s original registration date. Missing a deadline is nearly impossible to conceal: if an MAH fails to submit a PSUR on time, the product’s status changes in the system and the regulator sees this in real time.
The «Periodic Reports» section is used to compile and submit PSURs. Following the mandatory structure in Annex No. 13 of the EAEU Rules, each report must include the drug’s current registration status across all jurisdictions, data on both serious and non-serious adverse reactions, findings from newly concluded pre-clinical and clinical trials, and summaries of any changes to the product insert. Every modification is logged with a timestamp and justification — this is how the «digital footprint» of a drug’s evolving safety profile is built.
The «Adverse Reaction Notifications» section handles expedited reporting of Serious Adverse Reactions (SARs). The form captures data on the reporter, the patient (animal species, breed, age, weight), the suspected product (brand name, batch number, dosage, route of administration), and the clinical presentation (onset time, symptoms, outcome, and corrective actions taken). The system assigns each submission a unique tracking number. If Rosselkhoznadzor establishes a causal link between the drug and the reported reaction, the MAH receives a formal request to update the registration dossier.
Worth noting separately: Galen is integrated with the Mercury system — the national platform for electronic Veterinary Accompanying Documents (eVADs). If a cluster of SARs is linked to a single production batch, regulators can freeze the issuance of eVADs for that lot nationwide in real time. This turns pharmacovigilance from a paper-based procedure into an immediate enforcement tool.
What to Do
Appoint a QPPV and document the appointment. The EAEU Rules require designation of a Qualified Person for Pharmacovigilance (QPPV). The specialist must hold a university degree in a relevant discipline (veterinary medicine, biology, pharmacy, biotechnology, chemistry, or a related field), have at least five years of verifiable experience in drug manufacturing, quality control, or safety monitoring, and pass official state attestation under the established procedure (FZ-61, Part 4, on the placing of veterinary drugs on the market). Without a QPPV, a refusal at the five-year registration renewal is guaranteed.
Develop a Pharmacovigilance System Master File (PSMF). The document describes the corporate pharmacovigilance organizational structure, the QPPV’s qualifications, internal safety databases and IT systems (including data exchange protocols with Galen), the list of Standard Operating Procedures, third-party vendor agreements (if functions are outsourced), and internal audit plans. The PSMF is kept at the QPPV’s primary work location and must be produced immediately upon regulatory request.
Set up PSUR date tracking. At the five-year registration renewal, the applicant must submit a periodic safety report covering the entire commercial lifespan of the product, formatted according to Annex No. 13 of the EAEU Rules (Paragraph 99). Log into the Galen portal, locate each product in the portfolio, and check the system-generated submission calendar. Failure to meet these regulatory deadlines is classified as a material breach of pharmacovigilance obligations and is direct grounds for renewal refusal (Paragraph 129(b) of the EAEU Rules).
Build adverse reaction data collection workflows. Establish internal channels for receiving safety information from veterinary clinics, farms, and animal owners. Ministry of Agriculture Order No. 752 dated December 15, 2020 sets a firm deadline: any adverse reaction report must be submitted to Rosselkhoznadzor within 15 calendar days of the date the MAH first becomes aware of the incident. The EAEU Rules do not duplicate this deadline — in the veterinary sector they delegate spontaneous reporting timelines to national regulators. Pay special attention to reports citing lack of efficacy in vaccines and antibiotics: this is a priority category for Rosselkhoznadzor in its antimicrobial resistance monitoring work.
Align dossiers registered under national rules with the EAEU Pharmacopoeia by December 31, 2027. This requirement applies to all products registered under legacy national legislation prior to March 13, 2024. When submitting a dossier alignment application, all pharmacovigilance data accumulated in Galen must be compiled into an EAEU Annex No. 13 PSUR. Starting this data aggregation early will prevent regulatory bottlenecks.
During standard licensing audits, Rosselkhoznadzor cross-checks live Galen submissions against the PSMF. A blank safety history alongside significant sales volumes is an immediate trigger for an in-depth inspection. Companies that build their systems now will pass their five-year renewals without issues. Those who delay will face refusal.
Regulatory Framework:
1. Order of the Ministry of Agriculture of the Russian Federation No. 752 dated December 15, 2020, «On Approval of the Procedure for the Submission of Notifications by Entities Circulating Veterinary Medicinal Products Regarding Facts and Circumstances Provided for by Part 3 of Article 64 of Federal Law FZ-61» (registered with the Ministry of Justice February 12, 2021, under No. 62481; effective until March 1, 2028)
2. Decision of the Council of the Eurasian Economic Commission No. 1 dated January 21, 2022, «On the Rules Regulating the Circulation of Veterinary Medicinal Products within the Customs Territory of the Eurasian Economic Union» (as amended February 24, 2026)
3. Federal Law No. 61-FZ dated April 12, 2010, «On the Circulation of Medicinal Products» (as amended July 23, 2025)
4. Order of Rosselkhoznadzor No. 9 dated January 11, 2018, «On Approval of the Procedure for Conducting Pharmacovigilance Regarding Medicinal Products for Veterinary Use» (as amended October 7, 2020)
5. Order of the Ministry of Agriculture of the Russian Federation No. 534 dated September 9, 2019, «On Approval of the Procedure for the Receipt, Recording, Processing, Analysis, and Storage of Notifications Regarding Side Effects and Adverse Reactions by Marketing Authorization Holders of Veterinary Drugs…»