EAEU State-Initiated Drug Registration: What Subsection VII.VI of Decision No. 117 Means for Manufacturers
Imagine a situation: a drug is already registered in Russia, has proven its efficacy, and has passed all expert assessments. However, the manufacturer has no intention of submitting documents to Kazakhstan or Belarus — there is neither commercial interest nor the necessary resources. Patients in these countries are left without access to the medicine, even though it has long existed and worked successfully.
Since December 2024, this scenario has received a legal solution. The EEC Council, by Decision No. 117 dated November 29, 2024 (hereinafter — Decision No. 117), added Subsection VII.VI to the Rules for Marketing Authorization and Assessment of Medicinal Products for Human Use (EEC Council Decision No. 78 dated November 3, 2016, hereinafter — EAEU Rules). The authorized body of a member state can now independently initiate recognition of registration results for a drug already approved in another country of the Union.
This article examines how the mechanism works, how it differs from standard procedures, and what it changes for manufacturers.
How It Was Before
Before Subsection VII.VI, drug registration in the EAEU was built on a single principle: everything starts with the applicant. The manufacturer or their authorized representative submitted the dossier, underwent expert assessment, and received a marketing authorization (MA). Without an applicant, the process could not be launched.
In this model, the state always remained a reactive party: it received documents, verified them, and issued authorizations. It could not independently decide which drugs were missing from the market.
The limitations of this model became obvious after 2022. Some foreign manufacturers withdrew from the Russian market; others stopped expanding into neighboring Union countries due to logistical and economic pressures. Medicines that would have benefited patients simply did not appear on the market because no one submitted an application.
Different national practices within the EAEU compounded the problem. A medicine registered in Russia under the Union’s rules can formally circulate throughout the EAEU via the mutual recognition procedure — but even this requires the manufacturer’s initiative: submitting an application, paying fees, and waiting for recognition. If the manufacturer has no interest in doing so, patients in other countries wait.
What Changed in December 2024
Decision No. 117 introduced Subsection VII.VI into the EAEU Rules. Legally, this looks concise: the phrase «or at the initiative of the authorized body of a member state in accordance with Subsection VII.VI» was added to the list of grounds for issuing a marketing authorization. In practice, this introduces a fundamentally different registration logic.
The core of the mechanism is straightforward. An authorized body — such as Russia’s Ministry of Health — notices that a drug already registered in another EAEU country is absent from its domestic market. It makes a decision on the necessity of registration and initiates the recognition procedure without any application from the manufacturer.
Conditions for Application
The VII.VI procedure is triggered when two conditions are met simultaneously:
1. The drug is not registered in the initiating member state.
2. No analogous drugs exist in that state by International Nonproprietary Name (INN), active ingredient composition, or ATC (Anatomical Therapeutic Chemical) classification code at the 4th level.
The second condition matters: the mechanism is not designed to compete with drugs already on the market. Its purpose is to fill genuine gaps in drug availability.
How Recognition Proceeds
The authorized body does not conduct a full expert assessment from scratch. It recognizes the registration results from the reference state, drawing on three sources: the registration dossier submitted in the reference state; the current expert assessment report published in the unified registry; and publicly available information about the drug.
If necessary, the initiating body may request updated assessment reports, package inserts, and quality documentation from the reference state.
No state registration fee is charged for this procedure.
Marketing Authorization
The MA issued under Subsection VII.VI is placed in the unified registry with a corresponding mark and a link to the reference state’s expert materials. Its validity period cannot exceed the period of the authorization in the reference state, and may be shorter at the initiating body’s discretion.
Once the registration is complete, the initiating body retains permanent access to the dossier and all subsequent lifecycle changes. Translation of the package insert and packaging mock-ups into the state language is ensured where necessary.
Comparison with the Standard Procedure
| Parameter | Standard Registration | State-Initiated Registration (VII.VI) |
|---|---|---|
| Who initiates | Manufacturer / MAH | Authorized body of the member state |
| Basis for launch | Applicant’s dossier | Decision by the authorized body |
| Scope of assessment | Full assessment | Recognition of reference state results |
| Fee | Charged | Not charged |
| MA validity | General rules | No longer than reference state (may be shorter) |
| Territorial scope | Full EAEU (after mutual recognition) | Only the initiating member state |
| Registry entry | Standard | Marked as VII.VI with links to reference materials |
What This Means in Practice
At first glance, these changes seem to affect only regulators — the authorized body has gained a new tool. For manufacturers, the situation is more complex.
For those who have already registered a drug in at least one EAEU country, a real risk emerges: another member state can recognize your registration results without your participation. You become an MA holder in a country where you had no plans to operate, had not built any commercial infrastructure, and had not prepared local-language materials.
Subsection VII.VI formally provides for the authorized body’s access to the dossier and an obligation to ensure translation of the package insert. How these obligations will be divided between the initiating state and the MA holder — and who bears the operational costs — remains an open question that will require clarification from the EEC.
For orphan and niche drugs, the mechanism holds genuine promise. If a manufacturer has registered an orphan drug in Russia but does not plan to file in Kazakhstan due to the small market size, the Kazakh authorized body can theoretically secure patient access on its own initiative.
For manufacturers who have exited or are scaling down their EAEU presence, a new situation arises: registration in one Union state can trigger authorization in another without your request or involvement.
Historical Parallel and Context
Subsection VII.VI originates from EEC Council Order No. 34 dated October 17, 2022, which established the general concept of state-initiated recognition. At that point, the mechanism existed only as a statement of intent. Decision No. 117 filled it with concrete, binding procedural rules.
Similar approaches exist in global regulatory practice. In the EU, compulsory licensing applies when a manufacturer’s commercial interests conflict with public health needs. Subsection VII.VI operates under a similar logic — with an important difference: the state here recognizes an already completed registration rather than authorizing third-party manufacturing around the patent holder.
This raises a legitimate question about intellectual property. If the drug’s trade name is a registered trademark, the authorized body must account for the owner’s rights. Decision No. 117 contains no specific rules on how trademark issues are resolved under VII.VI — additional EEC guidance or case law will likely be needed.
What Manufacturers Should Do
The introduction of Subsection VII.VI is a clear signal to audit your regulatory portfolio. A practical action plan:
Map your EAEU portfolio. For each registered medicinal product, identify where you hold active MAs and where no analogous products exist by INN, composition, or ATC-4 code. These are the markets where Subsection VII.VI is most likely to be applied.
Verify your dossier status in reference states. If your drug is registered in Russia or Belarus and your expert reports are accessible in the unified registry, other EAEU countries can technically initiate recognition. Make sure your registry data is accurate and up to date.
Define your position on state-initiated registration. If you are open to it, consider engaging proactively with the relevant authorized bodies. If not, consult legal counsel on the regulatory and IP instruments available to protect your interests as an MA holder.
Track EEC working group updates. The mechanism is new and has no established practice. The Working Group on Common Approaches to Drug Regulation — reconstituted in 2024 — is where the practical interpretation of VII.VI will be worked out.
For orphan and rare disease products, consider the mechanism strategically. If you have registered an orphan drug in one EAEU country but lack resources for a full mutual recognition procedure elsewhere, Subsection VII.VI may be a lever in discussions with national health ministries to expand patient access at no registration cost.
While EAEU competent authorities have not yet applied VII.VI in practice, manufacturers have time to establish their position. It is far better to do that now than to discover later that your drug has been registered in another state using your dossier.
References
1. Decision of the EEC Council No. 117 dated November 29, 2024 «On Amending the Rules for Marketing Authorization and Assessment of Medicinal Products for Human Use»
2. Decision of the EEC Council No. 78 dated November 3, 2016 «On the Rules for Marketing Authorization and Assessment of Medicinal Products for Human Use» (as amended by Decision No. 93 dated November 26, 2025)
3. Order of the EEC Council No. 34 dated October 17, 2022 «On the recognition of marketing authorization results at the initiative of the authorized body of an EAEU member state»