Decentralized Procedure for Drug Registration in the EAEU: Timelines, Fees, and Real Value for the Applicant
Regulatory affairs managers typically justify choosing the decentralized procedure (DCP) in the EAEU by pointing to fee savings in the states of recognition. The logic seems clear: since the reference state does most of the work, the recognizing side should charge less. In practice, in Russia the duty is the same for both roles: for examining a medicinal product as reference state and for evaluating the assessment report as state of recognition, the competent authority charges the same state duty, 325,000 RUB. There is no tariff-based saving here.
The benefit of the decentralized procedure is not shaped by the fee schedule. It is created by the calendar. While the reference state conducts its examination, the states of recognition work in parallel and do not wait their turn, as they do under the Mutual Recognition Procedure (MRP). This difference in how the two procedures are run is what determines when DCP is worth it, and when it is simpler to follow the traditional sequential route.
Allocation of Roles Between the Reference State and the States of Recognition
The Rules for Registration and Examination of Medicinal Products for Human Use were approved by EEC Council Decision No. 78 of 3 November 2016 (hereinafter, Decision No. 78, as amended on 26 November 2025). Paragraph 20 of the Rules establishes two registration routes available at the applicant’s request: the Mutual Recognition Procedure and the decentralized procedure. The applicant selects the reference state and, if needed, the states of recognition at the filing stage.
The analysis below concerns new registrations, meaning products not yet registered in any EAEU member state. For medicinal products already in circulation under national rules, a separate procedure applies, bringing the dossier into compliance with Union requirements (Section XIII of Decision No. 78). The application for that procedure had to reach the reference state before 31 December 2025.
EEC Council Decision No. 34 of 22 May 2025 and EEC Council Decision No. 77 of 12 September 2025 extended the validity of national marketing authorizations that had already been filed for that procedure by that date: by no more than 3 years in the reference state from the filing date, plus another 2 years in each state of recognition from the date the application was filed there. Decision No. 77 of 12 September 2025 is easy to confuse with the identically numbered EEC Council Decision No. 77 of 3 November 2016 on GMP. These are two separate acts. Dossier alignment with Union requirements deserves a separate write-up and is not covered here.
Under MRP, the applicant first obtains a marketing authorization in the reference state, and only then initiates recognition in other Union countries. The timeframe for examination and registration in the reference state must not exceed 140 working days from the filing date to the issuance of the marketing authorization (Paragraph 46 of the Rules). The state of recognition joins the process later.
Once it receives access to the dossier and the assessment report, a state of recognition has no more than 60 working days to complete registration (Paragraph 68 of the Rules), of which the examination itself takes up to 40 working days (Paragraph 69 of the Rules). Waiting for the reference state to finish is mandatory. Even when applications are filed simultaneously with several states of recognition, the overall timeline to enter an additional market is made up of two consecutive stretches.
The decentralized procedure works differently. The application goes to the reference state and to all states of recognition nearly at the same time: Paragraph 88 of the Rules requires Module 1 of the dossier to be submitted to the authorities of the states of recognition no later than 14 working days after filing with the reference state. Examination in the reference state and review of the assessment report in the states of recognition run in parallel (Paragraph 85 of the Rules).
The overall timeframe for the procedure must not exceed 140 working days in the reference state and 50 working days in the states of recognition (Paragraph 84 of the Rules). Both stretches fit inside one shared window instead of stacking on top of each other.
Both procedures share one entry condition that affects the real timeline. Paragraph 29 of the Rules requires attaching to the dossier a valid document confirming that the manufacturing site complies with the Union’s Good Manufacturing Practice (GMP) rules. If no such document exists, Paragraph 30 of the Rules allows submitting its national equivalent together with a report on the site’s most recent inspection over the past 3 years.
The reference state decides on its own whether an unscheduled pharmaceutical inspection is needed (Paragraph 31 of the Rules). The absence of a Union GMP certificate does not block the filing. It adds the risk of an unscheduled inspection, and that inspection’s duration does not count toward the overall working-day limit, which can push actual market entry well past the timelines in the tables.
Timelines and Fees That Actually Determine the Benefit
The difference in how the two procedures are run produces a concrete, measurable gain in time. Under MRP, the minimum timeframe to enter a second market after the reference state is up to 200 working days: 140 in the reference state, plus up to 60 in the state of recognition, which joins the process only after the first stage is complete.
Under DCP, marketing authorizations in all countries are issued nearly simultaneously, within that same 140-working-day window in the reference state. Paragraph 105 of the Rules sets the 117th working day as the benchmark for finishing the examination when there are no objections from the states of recognition. Paragraph 109 allows up to another 20 working days to issue the final documents. The gap between the two procedures reaches 60 working days, roughly three calendar months of earlier access to additional markets.
Fees are not as one-sided as commonly assumed: the state duty for the reference-state role and the state-of-recognition role are equal, 325,000 RUB. Article 333.32.1 of the Tax Code of the Russian Federation sets these amounts directly. For a standard product, the rates are identical, and an applicant registering the same product in five countries through DCP pays Russia exactly what it would have paid for five separate national procedures. The rates differ only for products with well-established medical use: examination at registration costs 250,000 RUB, while the report evaluation as a state of recognition is cheaper, 165,000 RUB.
| Parameter | Mutual Recognition (MRP) | Decentralized (DCP) |
|---|---|---|
| Filing order | First to the reference state, then to the states of recognition | Simultaneously to all states |
| Timeframe in the reference state | Up to 140 working days | Up to 140 working days |
| Timeframe in a state of recognition | Up to 60 working days, starting after the reference state finishes | Up to 50 working days, in parallel with the reference state |
| Total minimum timeframe | Up to 200 working days | Up to 140 working days |
| Russian state duty, standard product | 325,000 RUB per role | 325,000 RUB per role |
| Russian state duty, well-established medical use | 250,000 RUB (reference state) | 165,000 RUB (state of recognition) |
| Issuance of the marketing authorization | 10,000 RUB | 10,000 RUB |
The only fee item where DCP is systematically cheaper for a standard product is that it avoids paying for a full quality-and-safety examination cycle again in every country, if the manufacturer was planning to register in all five states anyway. The fair comparison sets DCP against five independent national registrations. In that frame, parallel filing saves time above all: in Russia, the state duty for the state-of-recognition role equals the duty for the reference-state role across nearly every fee category, except the discounted category for well-established-use products.
Other member states set their own fees independently (Paragraph 3 of Decision No. 78), and the ratio between the reference-state fee and the state-of-recognition fee there may differ from the Russian one. Current fees are best requested directly from the competent authorities of Belarus, Kazakhstan, Armenia, and Kyrgyzstan. Applying Russian fee logic to the whole Union is risky.
When Parallel Filing Is Worth It, and When It Is Not
Parallel filing under DCP delivers the greatest benefit where the cost of delay outweighs the extra work of managing a dossier across several countries at once. For an originator product launching for the first time, every month of delay means lost revenue and a later start for patent protection across all five markets at once. For a generic entering a competitive market (cardiovascular drugs, diabetes treatments), appearing in the registry earlier often determines who wins procurement tenders first and secures a place on the pharmacy shelf.
Paragraph 24 of the Rules formally requires only one thing: only one state may act as the reference state. The practical choice is worth checking against three further criteria. First, the location of the manufacturing site: if the plant is in one of the five states, registering there as the reference state simplifies the logistics of scheduled and unscheduled GMP inspections. Second, the therapeutic area of the product: the law sets the same 140-working-day limit for all five competent authorities, but the actual workload of the expert organization for a given class of products differs from country to country.
That workload is worth finding out in advance, through pre-submission consultations, before filing. Third, coordination of queries: the reference state’s expert organization consolidates the comments from all states of recognition into a single request (Paragraph 94 of the Rules). How quickly that internal coordination happens determines whether the whole procedure fits into the 140 days.
The parallel process has a flip side: the risk of diverging expert opinions. The Union’s Good Manufacturing Practice rules (EEC Council Decision No. 77 of 3 November 2016) are the same for all five states, but national schools of expert review keep their own approaches to certain data, including the statistical significance of bioequivalence studies.
If a state of recognition raises reasoned objections to the draft assessment report and the parties cannot agree, the dispute goes to the Expert Committee on Medicinal Products under the EEC. The Committee reviews disagreements within 60 calendar days (Paragraph 108 of the Rules).
For biological and biosimilar products, where part of the safety data is collected only after launch, the parallel process works in the applicant’s favor. EEC Board Recommendation No. 15 of 10 June 2025 sets out shared approaches to using real-world data in the circulation of a medicinal product. It does not replace the dossier requirements. Its value lies elsewhere: under DCP, experts from several countries see the same real-world data at the same time and can align their position at the draft-report stage. Under MRP, that is not possible, because a state of recognition joins the case only after the reference state has already completed its own assessment.
For products with well-established medical use and for orphan drugs aimed at one or two markets with genuine demand, the time difference between DCP and MRP does not always justify the added logistics of filing in several countries at once. Here, the decision is made based on the specific list of target countries. The general rule «DCP is always faster» does not hold in these cases.
A separate factor in the market-entry economics, one that argues for earlier registration, is tax changes in individual Union states. As of 1 January 2026, Kazakhstan introduced VAT on medicinal products and medical devices at a rate of 5%, rising to 10% from 1 January 2027 (Tax Code of the Republic of Kazakhstan, Law No. 214-VIII of 18 July 2025; Resolution of the Government of the Republic of Kazakhstan No. 1204 of 31 December 2025). The list covers 242 product categories.
Action Plan
Compare DCP against the sum of independent national registrations across all target countries. Take the list of countries where the product will be sold, and calculate the combined state duty and combined timeframe for that scenario and for DCP, using the current fees of each country.
Assess the product’s therapeutic width and safety profile before choosing the reference state. For products with a high risk of expert disagreement, build 60 additional calendar days into the calendar for a possible referral to the Expert Committee.
Prepare a single master dossier and translations of the General Characteristics of the Medicinal Product and the Patient Information Leaflet into the languages of the states of recognition before filing. Paragraph 88 of the Rules gives only 14 working days to hand over Module 1 to the states of recognition, and a translation delay at this stage stalls the entire parallel process.
Hold pre-registration consultations with the competent authority of each candidate reference state and check the GMP certificate status of the manufacturing site. Paragraph 26 of the Rules allows such consultations at the applicant’s request. If there is no valid document confirming compliance with the Union’s Good Manufacturing Practice rules, gather the site’s inspection reports from the past 3 years in advance: this lowers the risk that the reference state will order an unscheduled inspection after filing.
Account for tax changes in Union countries when setting the product’s price. For the Kazakhstani market, build the 5% VAT rate from 2026 and the 10% rate from 2027 into the pricing model before filing for maximum-price registration.
The decentralized procedure speeds up entry into several Union markets at once. Its practical value rests on the parallel examination calendar, and the fee schedule plays a secondary role here. The choice of procedure is made case by case: the list of target countries, the type of product, and the real timelines matter more than general rules.
Regulatory Framework:
1. Decision of the Council of the Eurasian Economic Commission of 3 November 2016 No. 78, «On the Rules for Registration and Examination of Medicinal Products for Human Use» (as amended on 26 November 2025)
2. Decision of the Council of the Eurasian Economic Commission of 3 November 2016 No. 77, «On Approval of the Good Manufacturing Practice Rules of the Eurasian Economic Union» (as amended on 4 July 2023)
3. Decision of the Council of the Eurasian Economic Commission of 22 May 2025 No. 34, «On Amendments to Decision of the Council of the Eurasian Economic Commission of 3 November 2016 No. 78»
4. Recommendation of the Board of the Eurasian Economic Commission of 10 June 2025 No. 15, «On the Guidance on General Aspects of Using Real-World Data in the Circulation of a Medicinal Product»
5. Tax Code of the Russian Federation, Article 333.32.1 (as amended by Federal Law No. 299-FZ of 31 July 2025)
6. Tax Code of the Republic of Kazakhstan (Law of the Republic of Kazakhstan No. 214-VIII of 18 July 2025), Resolution of the Government of the Republic of Kazakhstan No. 1204 of 31 December 2025