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Registration of medicinal products

The registration of medicinal products is a multi-stage and labor-intensive process. The DOCLINX team, possessing significant experience and high qualifications in this field, provides professional services for the registration of medicinal products in accordance with the regulatory requirements of the Eurasian Economic Union (hereinafter referred to as the Union).

Why is registration of medicinal products necessary?

The production, storage, transportation, import/export, advertising, dispensing, sale, transfer, and use of medicinal products are permitted only if they are registered by the authorized body of a member state of the Union.

Eurasian Economic Union

Until 2014, the member states of the Eurasian Economic Union (Republic of Armenia, Republic of Belarus, Republic of Kazakhstan, Kyrgyz Republic, and Russian Federation) were guided by their own national regulations for the registration of medicinal products. In 2014, a strategic decision was made to form a single market for medicinal products within the Union. This involves the development and implementation of unified regulatory legal acts governing the circulation of medicinal products. Supranational regulation includes the following areas:

Development
Preclinical studies
Clinical trials
Registration
Manufacturing
Wholesale distribution
Pharmacovigilance
Dispensing procedures
Quality control

Registration procedure

The main feature of the registration of medicinal products in the territory of the Union is the possibility of using two alternative approaches:

Sequential registration in several member states through the mutual recognition procedure.
Simultaneous registration in several member states in accordance with the decentralized procedure.

When submitting an application for registration, the applicant has the right to independently determine the reference state and the recognition states. It should be noted that only one state can act as the reference state.

Mutual recognition procedure

The mutual recognition procedure is carried out by the reference state for the purpose of circulating the medicinal product in the market of that state only. Within this procedure, the reference state is considered to be the member state of the Union responsible for preparing an expert report on the assessment of safety, efficacy, and quality of the medicinal product based on the conducted expertise.

The algorithm of the procedure includes the following stages:

The expert organization of the reference state conducts a comprehensive assessment of the medicinal product;
If a positive conclusion is reached, the applicant is issued a registration certificate;
Information about the registered product is entered into the Unified Register.

After successful registration of a medicinal product in one of the member states of the Union, the applicant has the right to apply to the authorized bodies of other member states for registration of the product through the mutual recognition procedure. In this situation, the expertise will be carried out based on the review of the application, the applicant's documents, the information in the registration dossier, as well as the expert assessment report of the reference state.

With a positive result, the recognition state:

Issues a registration certificate to the applicant;
Approves the quality documentation of the reference state;
Enters information about the medicinal product into the Unified Register.

After completing these procedures, the product gains the right to circulate in the market of that state. If the state does not recognize the expert report of the reference state, the documentation is sent to the Expert Committee on Medicinal Products at the Eurasian Economic Commission for dispute resolution. Based on the review results, the authorized body of the recognition state makes the final decision on registration or refusal to register the medicinal product.

Decentralized registration procedure

This procedure is implemented simultaneously by several member states of the Union to which the registration application is submitted. The applicant determines the reference state and the recognition states. The process includes two parallel stages:

Registration of the medicinal product in the reference state;
Recognition of the assessment expert report and registration in the recognition states.

The authorized bodies of the reference state and recognition states conduct a joint expertise of the medicinal product. After the reference state prepares a positive draft of the final expert report, it is reviewed by the expert organizations of the recognition states. Registration certificates are issued to the applicant and information about the medicinal product is entered into the Unified Register only after receiving positive conclusions from the expert organizations of all participating states. It is important to note that the registration certificate issued by the authorized bodies of the recognition state has a validity period established by the authorized body of the reference state.

Bringing into compliance with the requirements of the Union

The transition to supranational regulation is carried out in stages over several transitional periods. The key date is December 31, 2025 - by this deadline, all medicinal products previously registered under national procedures must be brought into compliance with the unified requirements of the Union. To implement this task, the regulatory framework of the Union provides for a special "Procedure for bringing the registration dossier of a medicinal product registered under the rules of a member state into compliance with the requirements of the Union".

Estimated timelines for registration procedures (using the example of the Russian Federation)

New registration of a medicinal product: 8 to 14 months
Bringing into compliance with the requirements of the Union: 5 to 7 months

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Regulatory acts

The regulatory framework governing the field of medicinal product registration represents a comprehensive system of documents. The fundamental legislative acts of the EAEU in this area are presented below:

Agreement on Common Principles and Rules for the Circulation of Medicinal Products within the EAEU dated 23.12.2014
Decision of the EEC Council dated 03.11.2016 No. 78 "On the Rules for Registration and Expertise of Medicinal Products for Medical Use"
Decision of the EEC Council dated 03.11.2016 No. 76 "On Approval of Requirements for Labeling of Medicinal Products for Medical Use and Veterinary Medicinal Products"
Decision of the EEC Council dated 03.11.2016 No. 88 "On Approval of Requirements for the Instructions for Medical Use of a Medicinal Product and the General Characteristics of a Medicinal Product for Medical Use"
Decision of the EEC Board dated 07.09.2018 No. 151 "On Approval of Guidelines for Compiling a Normative Document on the Quality of a Medicinal Product"
Decision of the EEC Board dated 10.05.2018 No. 69 "On Approval of Requirements for Stability Studies of Medicinal Products and Pharmaceutical Substances"
EEC Recommendation dated 29.01.2019 No. 2 "On Guidelines for Selecting Trade Names of Medicinal Products"
Decision of the EEC Board dated 29.12.2015 No. 178 "On Rules for Determining Categories of Medicinal Products Dispensed Without a Prescription and by Prescription"
Recommendation of the EEC Board dated 10.09.2019 No. 28 "On Guidelines for Determining the Scope of Laboratory Tests in the Expertise of Medicinal Products"