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Pharmaceutical /Medicine/Drug/OTC registration in Russia

Pharmaceutical /Medicine/Drug/OTC registration in Russia

MOH – Russian Ministry of Health  

MOH Website-

Regulatory Authority- Minzdrav

Local Authorized Representative Required –Yes

Russia is a member of the Eurasian Economic Union and thus, issues associated with the state registration of medicinal products in Russia are regulated by the Decision of the Council of the Eurasian Economic Commission.

Drug Registration in Eurasian Economic Union

  • Mutual Recognition

A Market Authorization Holder (MAH) is a crucial component in streamlining the medication registration procedure in the dynamic and quickly changing pharmaceutical market of the European Union (EAEU). An individual or a business can take on this position; they are not required to be citizens of an EAEU member state. In essence, the MAH is in charge of guaranteeing the efficacy and safety of the medications they manufacture or supply throughout the union.

In the EAEU, the mutual recognition mechanism provides a quick and easy way to get drug approval. The registration dossier and other required documents are sent to the Competent Authority (CA) after the Market Authorization Holder (MAH) chooses a reference state.

In about two weeks, the CA reviews the records in order to determine whether to move forward with a full investigation. This comprehensive examination examines the trial results in conjunction with the medical product’s quality, safety, and efficacy. The authorities have the right to examine medicine samples for quality and do an ad hoc examination of production sites if they think it is required.

After the roughly six-month-long evaluation process, the CA drafts an expert report and decides whether to approve or deny the Market Authorization Application (MAA) for the medicine. An additional two weeks are spent in this decision-making process. The procedure can take up to 210 calendar days in total, though it may be extended if the CA asks for more details.

A five-year registration certificate is provided following market approval. Every EAEU member state uses the same model for this certificate. The validity of the certificate usually lasts forever upon re-registration.

  • Decentralized Procedure

Within the European Union, a different route to market authorization is provided by the decentralized medication registration process. This approach entails simultaneously submitting an MAA to multiple EAEU members, if not all of them.

In this process, most administrative procedures are handled by one member state, designated as the reference. This reference state is frequently selected according to criteria like its market size, regulatory ability, or significance to the drug’s therapeutic area.

The evaluation is carried out by the reference state, and the other states to which the application has been submitted are informed of its results. The marketing permission is granted by the reference state and confirmed by all participating states if no objections are raised by the other states.

When a business wants to simultaneously introduce a product into several EAEU nations, it frequently takes this route. Getting extensive market authorization through this method can be quicker and more effective than applying separately for each state.

By streamlining the EAEU’s drug registration system, both of these measures hope to facilitate MAHs’ efforts to introduce safe and effective medications onto the market. Any pharmaceutical business or individual wishing to navigate the drug registration landscape in the European Union must have a thorough understanding of these channels.

Drug Approval Process

1.Application for Drug Registration –The Application for the Drug Registration is done in the eCTD format.

2.Review by Department for State Regulation of Drugs Circulation (MoH)-The Drug Division of the Russia reviews the application for the new drug registration.

3.Expert Review: Conducts a thorough expert review of the registration application. A team of experts assesses the data to ensure that the drug is safe, effective, and of high quality.

4.Decision of Approval: Mindrav decides whether to license the medication for sale in Russia based on the findings of the expert review. A marketing authorization is given to the medication if it is accepted.

5.After-Market Monitoring: Post-approval surveillance is carried out to keep an eye on the medication’s effectiveness and safety in real-world settings. This aids in locating any uncommon or persistent negative effects that might not have shown up during clinical studies.

Documents Required

* Name of pharmaceutical preparation

* List of active ingredients and components

* Application for State registration of pharmaceutical, which includes the name of the pharmaceutical preparation, the name and contact information of the manufacturer

* Suggested dosage, usage guidelines

 * Drug description, packaging, shelf life, and storage requirements

* Manufacture’s Power of Attorney, given to the designated company to handle the registration process.

* Copy of Free sale Certificate.

*Copy of GMP certificate

*Certificate of Analysis

*Certificate Of Trademark

*Certificate of Manufacturer License                                            Generic Approval Process       

A clinical/BE/therapeutic equivalence study should be conducted in the territory of Russia.

  • The registration process for the generic is the same as for the branded medication if it is being registered before or at the same time as the branded medication.
  • If the generic is registered in the INN and has been available in Russia for more than 20 years, there is no need for a clinical trial.

Five fundamental components make up the EAEU’s eCTD, each of which has a distinct function in proving the quality, safety, and efficacy of a medication. What these modules include is as follows:

1.Administrative Data: This comprises the necessary administrative information regarding the drug, the applicant, and the application itself.

2.An overview of the shared technical document: An overview of the material found in modules 3, 4, and 5 is given here. It acts as a guide for comprehending the preclinical, clinical, and formulation aspects of the medication.

3.Quality: This module provides comprehensive details regarding the drug’s ingredients, production method, and quality assurance procedures.

4.Pre-clinical study reports: These comprise comprehensive summaries of all non-clinical research that determine the safety profile of the medication.

5.Clinical Trial Reports: These summarize all the data from clinical trials and show how safe and effective the medication. 

License Validity- 5 years

Registration Timeline –12

Registration fee- RUB 330,000