EAEU medicine review takes 140 working days, Russian registration 160. Time spent answering expert requests is not counted
The Rules for Registration and Regulatory Review of Medicines for Medical Use (hereinafter the Rules), approved by Decision of the Council of the Eurasian Economic Commission (EEC) No. 78 of 3 November 2016 (hereinafter Decision No. 78), limit the registration and regulatory review of a product in the reference state (the EAEU member state that prepares the expert report on the product) to 140 working days. The time the applicant takes to submit documents in response to a request from the authorized body or the expert organization is not included in that period. The applicant’s total response time for requests does not exceed 180 working days.
In Russia, the registration of a medicinal product for medical use takes no more than 160 working days from the date the application is accepted (under Federal Law No. 61-FZ of 12 April 2010 «On the Circulation of Medicines», hereinafter 61-FZ). The time of a request and of the answer to it is not counted in that period.
Registration and review timelines in Russia, and time that is not counted
The Russian Ministry of Health carries out the state registration of medicinal products for medical use (under the Regulation on the Ministry of Health of the Russian Federation, approved by Resolution of the Government of the Russian Federation No. 608 of 19 June 2012). 61-FZ calls this body the authorized federal executive body. Of the 160 working days, the expert panel has up to 110 working days for the review of the quality of the medicine and the review of the ratio of expected benefit to possible risk of using the product. These 110 working days run from the day the Ministry of Health’s assignment and the necessary documents are sent to the personal account of the expert institution in the unified system.
Before 1 March 2026, 10 working days were allowed for checking the completeness, reliability and correct execution of the dossier documents (under the version of 61-FZ of 23 July 2025). From 1 March 2026, the Russian Ministry of Health carries out this check within 4 working days of accepting the application. Before 1 March 2026, 10 working days were allowed for the registration decision (under the version of 61-FZ of 23 July 2025). From 1 March 2026, the Russian Ministry of Health takes the decision within 4 working days of receiving the conclusions of the expert panel.
For veterinary medicinal products, the registration period before 1 March 2026 was 120 working days (under the version of 61-FZ of 23 July 2025). From 1 March 2026, it is 108 working days.
The time limits were changed by Federal Law No. 304-FZ of 31 July 2025 «On Amendments to Certain Legislative Acts of the Russian Federation» (hereinafter 304-FZ). Its provisions amending 61-FZ entered into force on 1 March 2026. The entry-into-force provisions of 304-FZ contain no rule for applications submitted before that date.
Accelerated review takes no more than 80 working days, of which no more than 10 working days are for the review of the dossier documents and no more than 60 working days for the quality review and the benefit-risk review. Accelerated review applies to orphan medicines (those intended to treat rare diseases), the first three generic medicines under the same international nonproprietary name or grouping name, veterinary medicinal products for the treatment of companion animals that are also registered as medicinal products for medical use, and medicinal products intended exclusively for minors.
Time is not counted in the time limit for requests and for the submission of samples:
| What is requested or submitted | Applicant’s time limit | What happens to the time limit |
|---|---|---|
| Materials missing for the expert, at the request of the expert institution | Up to 90 working days from the day the expert institution receives electronic notification that the applicant has received the request | The time from the day the request is sent to the day the response is sent is not counted in the review time limit |
| Clarification of information in the dossier documents, at the request of the Russian Ministry of Health | Up to 90 working days from the day the Russian Ministry of Health receives electronic notification that the applicant has received the request | The time limit for the check is suspended from the day the request is sent to the day the response is sent. Failure to respond within the time limit is grounds for refusing to arrange the reviews |
| A copy of the conclusion that the manufacturer complies with GMP (Good Manufacturing Practice) requirements, or a copy of the certificate, if the applicant has submitted a copy of the decision to conduct a pharmaceutical inspection | Up to 180 working days from the day the expert institution receives electronic notification that the applicant has received the request | The time from the day the request is sent to the day the copy is sent is not counted in the review time limit |
| Samples of the medicinal product and the active pharmaceutical ingredient | 90 days from the day the Russian Ministry of Health receives notification that the applicant has received the decision to conduct the reviews; 30 working days for veterinary medicinal products | The time for submitting samples is not included in the time limit for the reviews |
The review time limit is suspended from the day the request is sent to the applicant’s personal account, while the applicant’s 90 working days run from the day the expert institution receives electronic notification that the applicant has received the request.
Review timelines under the EAEU Rules for the reference state and the state of recognition
The Rules provide for two procedures: mutual recognition and the decentralized procedure. In mutual recognition, the state of recognition (the member state where the product is registered on the basis of an assessment of the reference state’s expert report) assesses a report that the reference state has already prepared. In the decentralized procedure, registration and review in the reference state and the stages in the states of recognition take place at the same time.
| Parameter | Russia, 61-FZ | EAEU, the Rules |
|---|---|---|
| Overall registration period | 160 working days for medicinal products for medical use, 108 for veterinary medicinal products | 140 working days in the reference state; 60 working days (mutual recognition) or 50 working days (decentralized procedure) in the state of recognition |
| Check of the completeness of the dossier | 4 working days | 10 working days |
| Missing materials identified during the check | Up to 90 working days to respond to a request from the Russian Ministry of Health | Up to 90 working days, not included in the registration period |
| Response to a request from experts | Up to 90 working days | Up to 90 working days |
| Maximum total period for responses to all requests | 61-FZ sets no overall limit for requests from experts | 180 working days |
| If the applicant does not respond within the time limit | Failure to respond to a request from the Russian Ministry of Health is grounds for refusing to arrange the reviews | Review and registration are terminated, and the applicant is notified within 14 working days |
Within the 140 working days, the review takes no more than 105 working days from the day the completeness, document set and correct preparation of the dossier are assessed, or from the day the expert organization receives the assignment. The assessment of the applicant’s response to a request for missing materials takes no more than 5 working days from its receipt.
| Stage | Time limit |
|---|---|
| Registration and review in the reference state | No more than 140 working days |
| Registration in the state of recognition, mutual recognition | No later than 60 working days from the day the expert organization gains access to all versions of the electronic dossier and to the approved expert report, if there are no disagreements between the authorized bodies and there is a conclusion that the report can be recognized |
| Registration in the state of recognition, decentralized procedure | No more than 50 working days |
| Request from the state of recognition in mutual recognition | If necessary, sent no later than 30 working days after access to the expert report is obtained |
| Applicant’s response to the state of recognition | No more than 90 working days, not included in the time limit |
| Decision of the reference state to initiate an unscheduled inspection | May be taken no later than 70 working days from the day the application is submitted |
If the upper limits are added together, the result is 140 working days for registration and review in the reference state, 90 working days for missing materials and 180 working days for responses to requests, 410 working days in total. On a five-day working week, without allowing for public holidays, this is 82 working weeks, that is, more than a year and a half.
In the decentralized procedure, the reference state sends the states of recognition, within 60 working days of the start of the review, reports with comments, a preliminary report or copies of requests to the applicant. If the states of recognition have additional comments for the applicant, they send their requests to the reference state no later than 30 working days from receipt of the preliminary report. Within 20 working days of receiving the last request, the reference state forms a single request and sends it to the applicant. If the states of recognition have no comments or the comments have been resolved, the review is completed within 10 working days, on the 117th working day from the day the application is submitted.
What suspends the review time limit and what resumes it
A request from the reference state is sent to the applicant in electronic form and is considered received after 1 working day from the day it is sent. In the decentralized procedure, a request is considered received after 1 calendar day, and the review is suspended from the day the comments are sent to the applicant. A request from a state of recognition in mutual recognition is considered received after 1 calendar day if sent through communication channels and after 6 calendar days if sent by registered letter. The response period of 90 working days runs from the day the request is received.
A request may concern missing information, explanations or clarifications of the dossier documents, including proposals to amend the summary of product characteristics (SmPC), the package leaflet, the packaging mock-ups and the normative document on quality. After the first request, further requests are permitted only on additional issues that relate to information from the applicant’s response to the previous request.
The authority of the reference state may extend the response period on the applicant’s justification. The total period for responses to all requests does not exceed 180 working days. After the responses are submitted, the review resumes. If the applicant does not submit what was requested within the time limit, the review and registration are terminated. The decision is sent to the applicant and to the authorized bodies of the states of recognition within 14 working days of the day it is taken.
The applicant agrees that the draft final expert report contains no confidential information within no more than 10 working days from the day the draft is received, and these days are not included in the registration and review time limit. The condition is that the dossier contains a documented intention of the applicant to agree that there is no such information. The assessment of the applicant’s response takes no more than 5 working days and is not included in the registration and review time limit.
The applicant submits with the dossier a valid document confirming that the manufacturing site complies with the Union’s GMP requirements. Instead, the applicant may submit, until it expires, a GMP compliance document issued to the manufacturer by the authorized body of a member state. If a valid document cannot be submitted, the applicant submits instead the documents and information listed in the Rules. On the basis of these documents, the reference state decides whether to conduct an unscheduled inspection during the registration procedures or to include the inspection in the plan for the first 3 years after they are completed. The decision to initiate an unscheduled inspection may be taken no later than 70 working days from the day the application is submitted. The reference state then sends the applicant a request to arrange the inspection. The response to this request is given within the same time limits as the response to a request from experts: up to 90 working days, extended on the applicant’s justification, but no more than 180 working days in total. The applicant arranges the unscheduled inspection.
The review is not interrupted during unscheduled inspections, but the reference state may draw up the final expert report only after taking their results into account. In one place the Rules set a maximum of 180 calendar days for an inspection from the day the decision to initiate it is taken, and in another they give 180 working days from the same day.
Dossier alignment with Union requirements and the periods of 70 working days, 3 years and 2 years
Dossier alignment (the procedure by which the registration dossier of a product registered under the rules of a member state is brought into line with Union requirements) is governed by the Rules. Dossier alignment takes no more than 70 working days from the day the application is submitted. The applicant sends the response to a request within up to 90 working days, the total period for responses does not exceed 180 working days, and the response time is not included in the time limit of the procedure. If the applicant does not submit what was requested within the time limit, the procedure is terminated.
The 3 years and 2 years in Decision No. 78 relate to the validity period of the national registration certificate. Decision No. 78 extends registration certificates for which an application for dossier alignment (or an application to amend the dossier stating the states of recognition in which the product was previously registered) was submitted to the reference state before 31 December 2025 and the procedure had not been completed by that date. The registration certificate is extended for the duration of the procedure, but for no more than 3 years in each of the member states named in the application, from the day the application is submitted to the reference state. It is additionally extended for the duration of the procedure in the state of recognition, but for no more than 2 years from the day the application is submitted to the state of recognition. The application to the state of recognition is submitted no later than the day the 3-year period from the submission of the application to the reference state expires.
The application for dossier alignment must have been submitted to the reference state before 31 December 2025. For products for which the application was submitted before 31 December 2025 and the procedure is not completed, the registration certificate is extended on the same terms (3 years and 2 years), and the status of the certificate in the State Register of Medicines remains «Valid» (letter of the Russian Ministry of Health of 29 January 2026). For products that have completed dossier alignment, the member state’s registration certificate is extended for 180 calendar days from the date of dossier alignment, manufacture under that certificate is permitted during this period, and circulation is permitted until the end of the shelf life (letter of the Russian Ministry of Health of 29 January 2026). For products for which no application was submitted, circulation is permitted until the end of the shelf life, if the product was manufactured before the registration certificate expired and was released into civil circulation before that date (letter of the Russian Ministry of Health of 29 January 2026).
For products with no application, Resolution of the Government of the Russian Federation No. 353 of 12 March 2022 «On the Specifics of Permitting Activities in the Russian Federation» (hereinafter Resolution No. 353) also applies. Resolution No. 353 permits, until 1 January 2027, the circulation of products for which no application was submitted before 31 December 2025 and which, as of 1 December 2025, had been released into civil circulation for at least the last 3 calendar years. The registration certificates of such products are extended until 1 January 2027.
What to do
Keep a request calendar for each procedure. For each request record three dates: sent, received and the end of the response period. In the reference state a request is considered received 1 working day after it is sent, in the decentralized procedure 1 calendar day after. In Russia the applicant’s 90 working days run from the day the expert institution receives electronic notification that the applicant has received the request. Keep a separate count of the days used: under the Rules the overall limit for responses to requests is 180 working days.
Send the justification for an extension before the first 90 working days end. The authority of the reference state may extend the period on the applicant’s justification. State in the justification which data cannot be collected within 90 working days and why.
Answer the first request in full. Further requests are permitted only on questions from your response. Put the answer for all modules in one package and cross-check the SmPC, the package leaflet, the packaging mock-ups and the normative document on quality, because a request may concern any of these documents.
Prepare the GMP documents and samples before filing the dossier. A valid document confirming compliance with the Union’s GMP requirements is part of the dossier when the application is filed. Samples of the medicinal product and the active pharmaceutical ingredient for review in Russia are submitted within 90 days after notification of the decision to conduct the reviews. The Rules give the time limit for an unscheduled inspection in calendar days in one place and in working days in another, so plan for the shorter period, 180 calendar days from the day of the decision to initiate it.
Check the status of dossier alignment for every product in the portfolio. If the application was submitted before 31 December 2025, answer requests within 90 working days, otherwise the procedure is terminated. For products with no application, compare the end of the shelf life and the expiry date of the national registration certificate with the conditions of Resolution No. 353. Resolution No. 353 permits circulation until 1 January 2027.
Regulatory framework:
1. Decision of the Council of the Eurasian Economic Commission No. 78 of 3 November 2016 «On the Rules for Registration and Regulatory Review of Medicines for Medical Use» (as amended on 26 November 2025)
2. Federal Law No. 304-FZ of 31 July 2025 «On Amendments to Certain Legislative Acts of the Russian Federation» (as amended on 4 August 2026)
3. Federal Law No. 61-FZ of 12 April 2010 «On the Circulation of Medicines» (as amended on 4 August 2026, with amendments taking effect on 1 September 2026; the version of 23 July 2025 was used for the previous time limits)
4. Resolution of the Government of the Russian Federation No. 608 of 19 June 2012 «On Approval of the Regulation on the Ministry of Health of the Russian Federation» (as amended on 9 September 2026)
5. Resolution of the Government of the Russian Federation No. 353 of 12 March 2022 «On the Specifics of Permitting Activities in the Russian Federation» (as amended on 23 September 2026)
6. Letter of the Russian Ministry of Health No. 25-6/894 of 29 January 2026 «On the Transition Period under the Procedure for Aligning the Registration Dossiers of Medicinal Products Registered under the Rules of Member States with the Requirements of International Treaties and Acts Constituting EAEU Law»