Medicinal Product Registration Procedure in the Russian Federation

Registering a medicinal product is a mandatory gateway every manufacturer must pass before legally entering Russia’s pharmaceutical market. The registration dossier undergoes a state evaluation that confirms product quality and weighs the expected therapeutic benefit against potential risks. Successful completion of the procedure opens the way to lawful use, distribution, and medical application of the medicine throughout the Russian Federation.

The principal legal framework is Federal Law No. 61‑FZ “On the Circulation of Medicines,” adopted on 12 April 2010 and effective since 1 September 2010. This act lays down strict criteria for products subject to mandatory registration and prescribes the entire sequence of actions that the applicant must follow to achieve approval.

The law requires registration for all new medicinal products appearing on the Russian market for the first time. Medicines already known must also be registered if they are introduced in new dosage forms or with modified strengths, provided those changes are clinically significant. In addition, innovative combinations of previously registered substances fall under the same rule, ensuring that every therapeutic novelty passes the same safety and efficacy threshold.

Responsibility for conducting the registration rests with the Ministry of Health of the Russian Federation. The manufacturer must submit a complete set of documents forming the registration dossier together with an official application in the approved format. Legislation sets the maximum review period at 160 working days from the date the application is accepted by the authorised body, after which the applicant receives an approval decision or a justified refusal.

The process involves a detailed examination of all submitted materials, necessary expert assessments and laboratory studies, and an appraisal of manufacturing facilities and quality‑control systems. Specialists carefully analyse chemical composition, manufacturing consistency, pre‑clinical results, and clinical outcomes. A positive decision is issued only when every requirement for safety, efficacy, and quality has been fully satisfied.

Key Conditions for a Successful Application

The cornerstone of the procedure is a correctly executed application for state registration. This paper must contain full information on the product and the applicant company. A second obligatory component is the Common Technical Document (CTD), which provides exhaustive data on the medicine across quality, non‑clinical, and clinical sections.

Special rules apply to generic (reproduced) medicines. Instead of providing their own pre‑clinical studies, developers may submit a scientific review of investigations on the reference product. Likewise, clinical trials may be replaced with a bioequivalence study report. This approach significantly simplifies registration for generics while maintaining the necessary level of quality and safety control, helping manufacturers save time and money and ensuring affordable therapy for patients.

Comprehensive Support for Registration of Medicinal Products

Expert Support:

• Professional consultations on registration procedures
• Comprehensive assistance in assembling the registration dossier
• Methodological help in preparing and formatting documentation
• Expert guidance through every stage of registration

Scientific and Research Support:

• Coordination of pre‑clinical and clinical studies
• Comparative analysis of dissolution kinetics
• Monitoring of laboratory quality testing of medicines
• Preparation of scientific reviews on reference products
• Organisation of bioequivalence studies

Documentation Support:

• Professional preparation of the registration dossier
• Liaison with registration authorities
• Making changes to registration materials
• Preparation of supplementary documentation
• Support in obtaining permitting documents

Additional Services:

• Monitoring validity periods of registration certificates
• Updating registration documentation
• Preparing responses to regulatory requests
• Legal assistance with registration procedures
• Consulting on medicinal‑product circulation issues

Additional Areas of Our Activity in Drug Registration

Documentation Support:

• Professional drafting of instructions for use
• Comprehensive assistance in obtaining registration certificates
• Preparation and updating of accompanying documents
• Drafting normative and technical documentation

Post‑Registration Monitoring:

• Establishment of a pharmacovigilance system
• Monitoring medicine safety
• Assessing the benefit–risk ratio of medicinal products
• Analysing clinical use data

Updating Documentation:

• Introducing amendments to regulatory documents in line with new legislation
• Updating instructions for medical use
• Adjusting technical documentation
• Bringing documents into compliance with current standards

Expert Support:

• Consulting on compliance with regulatory requirements
• Methodological assistance in preparing documentation
• Support during the process of making changes
• Solving complex issues during registration

NVR Consult Group guarantees comprehensive support at every stage of the registration process, high‑quality services, and an individual approach to every client. Our long‑standing expertise allows us to address tasks of any complexity and to help partners bring effective and safe medicines to the Russian market swiftly and confidently.