Roszdravnadzor Order No. 3518 Splits Adverse Reaction Reporting Into 3-Day and 15-Day Deadlines
A new pharmacovigilance procedure has been in effect in Russia since March 1, 2025. Most companies found out about it precisely when it entered into force. Formally, six months were allocated for preparation: from the moment the order was registered with the Ministry of Justice (September 2024) until its effective date. During those six months, companies had to restructure their internal SOPs, train personnel, and establish workflows with the AIS Roszdravnadzor (Automated Information System). Those who put the task off until «later» faced a rigid constraint: a three-working-day deadline to report a fatal outcome is a hard regulatory deadline, not a buffer.
The changes affected more than just deadlines. The new order redistributed information flows among medical organizations, marketing authorization holders (MAHs), and Roszdravnadzor. Risk management plans and urgent safety notifications — which previously existed within the EAEU GVP but lacked a national operational mechanism — were added to the list of grounds for pharmacovigilance.
How Pharmacovigilance Worked Before March 2025
Until March 1, 2025, the framework rested on Roszdravnadzor Order No. 1071 dated February 15, 2017, as amended in 2020. Under the old rules, medical organizations and MAHs transmitted information on adverse reactions within 15 days. There was no distinction between working days and calendar days for different categories of events.
The concept of an «urgent safety issue» (USI) existed at the level of the EAEU GVP (Decision of the EAEU Council No. 87 dated November 3, 2016), but the mechanism for its national implementation remained vague. Companies frequently interpreted the 15-day period as a universal one, including for cases that, starting from 2025, require a three-day response.
The technical infrastructure created a separate problem. The AIS Roszdravnadzor did exist; however, the mandatory nature of its use for all categories of subjects was not set out with the same clarity as in the new procedure. A portion of reports was submitted via email or on paper, and this was considered the norm. The boundary between an «urgent» and an «ordinary» event became blurred in operational practice.
The Pharmacovigilance System Master File (PSMF) was far from being maintained by all MAHs: the requirement was established in the GVP, but inspection pressure in this area remained limited. Routine inspections of pharmacovigilance systems were rare; non-routine ones primarily addressed specific safety signals. After March 2025, the situation changed: the completeness and currency of the PSMF became an independent subject of verification.
The table below shows the fundamental differences between the old and new procedures:
| Parameter | Until 01.03.2025 (Order No. 1071) | Since 01.03.2025 (Order No. 3518) |
|---|---|---|
| Deadline for fatal outcomes | 15 days (unified) | 3 working days |
| Deadline for urgent safety issues | Not regulated separately | 3 working days for MAHs |
| Deadline for other serious adverse reactions | 15 days | 15 calendar days |
| Main submission channel | AIS / email / paper | AIS (paper only for MAHs in case of urgent events) |
| PSMF as a subject of inspection | De facto optional | Independent ground for findings |
| Risk Management Plans | Not listed in the grounds for pharmacovigilance | Included in the grounds for pharmacovigilance |
| Urgent notifications | No separate operational mechanism | Separate email address (ESI@), mandatory paper duplicate |
What Roszdravnadzor Order No. 3518 Changed
Roszdravnadzor Order No. 3518 dated June 17, 2024, «On Approval of the Pharmacovigilance Procedure for Medicinal Products for Human Use,» was registered with the Ministry of Justice on September 5, 2024 (Reg. No. 79394), came into force on March 1, 2025, and is effective until March 1, 2031. It replaced Order No. 1071 of 2017, as amended.
The new Procedure establishes two time regimes depending on the severity of the event and the category of the subject.
Three working days apply to two scenarios.
The first covers medical organizations. They are obliged to report serious adverse reactions (ARs) resulting in death or posing a threat to life to Roszdravnadzor within 3 working days from the moment the official responsible for pharmacovigilance became aware of all the necessary information about the reaction (paragraphs 21 and 24 of the Procedure). An exception applies to reactions identified during clinical trials conducted within the same organization: those are governed by GCP rules rather than this procedure.
The second covers MAHs. They are required to send information falling under the definition of an urgent safety issue in accordance with paragraphs 756 and 757 of the EAEU GVP to Roszdravnadzor within 3 working days (paragraph 13 of the Procedure). Submissions are sent to ESI@roszdravnadozr.gov.ru with a mandatory follow-up hard copy. This is the only category of messages for which a paper duplicate is strictly mandatory rather than optional.
An urgent safety issue encompasses any information capable of significantly altering the benefit–risk assessment of a drug: new data on contraindications, a quality defect affecting safety, or epidemiological findings.
Fifteen calendar days apply to medical organizations for serious ARs that did not result in death and did not pose a threat to life, for cases of infectious disease transmission through a drug, for situations involving a lack of claimed efficacy of essential drugs and vaccines, and for reactions resulting from abuse (paragraph 22 of the Procedure). These are calendar days, not working days. Public holidays do not suspend the period.
| Event | Subject | Deadline | Type of Days |
|---|---|---|---|
| Serious AR with fatal outcome or life threat | Medical organization | 3 | Working |
| Urgent safety issue | MAH | 3 | Working |
| Serious AR without fatal outcome | Medical organization | 15 | Calendar |
| Transmission of infectious agent via drug | Medical organization | 15 | Calendar |
| Lack of efficacy of essential drugs and vaccines | Medical organization | 15 | Calendar |
| AR due to abuse or intentional overdose | Medical organization | 15 | Calendar |
Paragraph 24 of the Procedure establishes the «rule of four.» The countdown begins not from the moment of the event, but from the day when the official responsible for pharmacovigilance became simultaneously aware of: the person who identified the reaction; the patient; the drug; and the symptoms. As long as at least one of these four elements is missing, the clock has not formally started. This does not mean, however, that establishing the facts can be delayed: the regulator has the right to assess how promptly the organization collected the primary information.
All reports are submitted via the AIS Roszdravnadzor. In the event of system technical failures, reports are sent to pharm@roszdravnadzor.gov.ru. In the absence of technical capability for medical organizations, healthcare professionals, and patients, the address npr@roszdravnadzor.gov.ru is available.
After the system is restored, all reports sent by email must be entered into the AIS. Sending by email does not release from this obligation and does not replace the record in the system.
Periodic Reporting and the PSMF
In addition to the deadlines for individual reports, the Procedure establishes requirements for periodic documentation.
Periodic Safety Update Reports (PSURs) are prepared by MAHs in accordance with Section VIII of the EAEU GVP and submitted via the AIS. The frequency depends on the status of the drug. For drugs registered or brought into compliance with EAEU requirements, paragraph 698 of the GVP applies: reporting is tied to the harmonized international birth date of the drug. For drugs that retain national marketing authorizations and have not yet undergone the procedure of bringing the dossier into line with EAEU requirements, paragraphs 696 and 697 of the GVP apply.
The expert organization of Roszdravnadzor evaluates a PSUR within 60 working days from the date of receipt (paragraph 28 of the Procedure). If the PSUR does not comply with GVP requirements, a rejection notification is sent to the MAH’s personal account in the AIS within 5 working days from the date of the expert opinion. The MAH is obliged to remedy the deficiencies and submit the corrected document.
A separate line in the periodic reporting system is the Development Safety Update Report (DSUR), prepared by legal entities that have received permissions to conduct clinical trials. The requirements for DSURs are set out in Annex No. 12 to the EAEU GCP. The evaluation of a DSUR follows the same expert route as that of a PSUR, with the same 60-working-day period.
The PSMF must be updated in accordance with the current EAEU GVP Rules. It covers the organizational structure of the pharmacovigilance system, SOPs, contact details of the Qualified Person Responsible for Pharmacovigilance (QPPV), and a description of procedures for each category of events. Non-compliance of the PSMF with GVP requirements automatically constitutes a finding during an inspection.
The role of the QPPV has expanded under the new system. The EAEU GVP requires this person to be genuinely involved in safety decision-making: contact details must be current, and the PSMF must be signed with a current date and actually describe functioning procedures. Companies where the QPPV held a purely nominal role and did not participate in three-day decisions faced their first questions during the 2025 inspections. The regulator checks not only the existence of the position, but also evidence of actual work: event logs, information transfer records, and correspondence with manufacturing sites.
Requirements for reporting during clinical trials are governed not by Order No. 3518 but by the EAEU GCP (Decision of the EAEU Council No. 79 dated November 3, 2016). Information on Suspected Unexpected Serious Adverse Reactions (SUSARs) is submitted in accordance with paragraphs 1 and 2.2 of Annex No. 11 to the EAEU GCP.
Paragraph 12 of the Procedure explicitly establishes the separation: the MAH’s pharmacovigilance system operates under GVP, while clinical trial reporting falls under GCP. These two streams must not be mixed.
Administrative Liability
Violation of the established deadlines and procedure for submitting adverse reaction reports entails liability under Article 19.7.8 of the Code of Administrative Offences of the Russian Federation (CAO RF). The fines under this article are relatively modest: from 10,000 to 15,000 rubles for officials, and from 30,000 to 70,000 rubles for legal entities. Financial sanctions, however, are not the only consequence.
Under Article 65 of Federal Law No. 61-FZ, failure to fulfill pharmacovigilance obligations established by Parts 3 and 4 of Article 64 of FZ-61 constitutes in itself a ground for considering the suspension of the drug’s marketing authorization. Systematic violation of deadlines or total silence during serious events can entail consequences incomparably more severe than a fine under the CAO.
An additional risk comes from inspections of pharmacovigilance systems. Since the new procedure took effect, Roszdravnadzor has been verifying not only the fact of report submission, but also the documented response speed: the time between the date of the event and the date when the responsible officer obtained the necessary identifiers. If this interval is unreasonably long, the regulator has the right to question the quality of the system as a whole.
What to Do
Split SOPs into two tracks. One track should describe the procedure for events subject to the three-day deadline (fatal outcomes and urgent safety issues); the other covers everything else under the 15-day deadline. Both SOPs must name the specific official responsible for collecting the four identifiers and record the moment the countdown starts.
Appoint a pharmacovigilance duty officer. A deadline measured in working days means weekends do not shorten it — but an event can occur on a Friday evening or during a long public holiday period. A clear escalation mechanism that reaches the responsible person regardless of the day of the week is required.
Set up two separate channels for urgent and routine reports. For routine ARs: the AIS Roszdravnadzor, with the backup address pharm@roszdravnadzor.gov.ru. For urgent safety issues: exclusively ESI@roszdravnadozr.gov.ru, with a mandatory paper duplicate. Mixing channels creates risk: an urgent report submitted to the «routine» address may not be counted as timely.
Update the PSMF. If the document was prepared before March 2025, it does not reflect the new Procedure or the new submission addresses. Add a description of the procedure for urgent safety issues, references to paragraphs 756 and 757 of the EAEU GVP, and QPPV contact details current as of the update date.
Verify PSUR dates for every drug in the portfolio. The reporting regime depends on whether the drug is registered under EAEU rules or still holds a national marketing authorization. Discrepancies in categorization lead to errors in PSUR submission deadlines, and delays are flagged by the AIS automatically.
Three working days is not bureaucratic stringency. Behind this deadline lies a practical safety logic: if a drug leads to a patient’s death and the regulator learns about it three weeks later, the window for protective action narrows significantly. Companies that have integrated the three-day cycle into the operational rhythm of their pharmacovigilance gain a concrete advantage during GVP inspections: documented response speed reflects system maturity, not just technical compliance with the letter of the law.
Regulatory Framework:
1. Roszdravnadzor Order No. 3518 dated June 17, 2024, «On Approval of the Pharmacovigilance Procedure for Medicinal Products for Human Use» (effective March 1, 2025 through March 1, 2031; registered with the Ministry of Justice on September 5, 2024, Reg. No. 79394).
2. Decision of the EAEU Council No. 87 dated November 3, 2016, «On Approval of the Good Pharmacovigilance Practice Rules of the Eurasian Economic Union» (as amended May 19, 2022).
3. Federal Law No. 61-FZ dated April 12, 2010, «On the Circulation of Medicines» (as amended July 23, 2025), Articles 64–65.
4. Decision of the EAEU Council No. 79 dated November 3, 2016, «On the Good Clinical Practice Rules of the Eurasian Economic Union» (EAEU GCP).
5. Code of Administrative Offences of the Russian Federation, Article 19.7.8.