Procedure for registration of medicines in the Eurasian Economic Union (EAEU)

The supranational registration of medicinal products provides new opportunities to work in the common EAEU market.

The first applications for registration of medicines in accordance with the Agreement on common principles and rules of circulation of medicines within the framework of the Eurasian Economic Union (Agreement) of December 23, 2014 and the Rules of registration and expertise of medicines for medical use (approved by the Decision of the Council of the Eurasian Economic Commission N 78 of 03.11.2016) (EAEU Rules) have been adopted.

The Agreement, which came into force on February 12, 2016, stipulates that medicinal products may be put into circulation in the territory of the EAEU (and these are the territories of six states: Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia) only after the registration and expertise according to the EAEU Rules and the inclusion of medicinal products in the Unified Register of Registered Medicines of the EAEU.    This requirement applies not only to the entire territory of the EAEU, but also to the territories of individual Member States.

Immediately after the entry into force of the Agreement, the registration under the EAEU Rules did not start functioning due to the lack of necessary second- and third-level documents and unavailability of all technical means, however, in March-April 2018 there were reports about the applications accepted under the EEU Rules in Kazakhstan and Belarus. A full-scale launch is associated with the launch of a single integrated information system.
The unified integrated information system for accounting of medicines reflects the key processes of the common market of medicines, in particular, it will provide for the issuance and processing of applications in electronic form, communication between authorized bodies.   

The EAEU rules do not provide for a single centralized registration procedure; mutual recognition procedures and a decentralized procedure are implemented by national competent state authorities.

The said procedures have been modelled by analogy with the corresponding procedures in the EU.

The applicant chooses one State as the reference State, and a full cycle of registration procedures, including tests and inspections of proceedings, is carried out, resulting in an expert report. In other States, where registration is requested (recognition states), the authorised bodies evaluate the expert report of the reference State and individual modules of the common technical document. Under the mutual recognition procedure, registration in the reference State is initially conducted, followed by the recognition procedure. Under the decentralized procedure, both processes take place simultaneously. This procedure is suitable for those medicines that have not been previously presented on the EAEU market.

The established terms of recognition procedure are up to 210 calendar days in the reference State and up to 90 calendar days in the State of recognition. Decentralized procedure – up to 210 calendar days. These periods may be extended for the period of providing additional information in other cases as well.

In case of refusal in recognition, settlement of disagreements between state bodies involved in the procedure is carried out by the Expert Committee on Medicines established under the Eurasian Economic Commission of EAEU from representatives of member states.

As a result of the procedures, the applicant receives a uniform model registration certificate for each Member State in which the medicine was registered.

The validity period of a registration certificate for the first time registered medicinal product in the reference state is 5 years. Further there is a need to pass the procedure of confirmation of its registration (re-registration), according to its results, as a general rule, an open-ended registration certificate is issued. The period of validity of the registration certificate in the State of recognition will be the same as in the reference State.

A special procedure is envisaged to bring the registration dossier of a medicinal product registered before December 31, 2020 in the Member States in compliance with the requirements of the EAEU. The deadline for the procedure is December 31, 2025. The procedure is simplified and lasts up to 100 calendar days. If a medicinal product is registered in several Member States under national procedures, an application for the procedure of harmonization with the EEA Rules is submitted only to one of them that will act as a reference state, and in other Member States the harmonization will be carried out under the scheme of mutual recognition.
Authorized bodies of the Member States, following the results of the procedure for bringing a medicinal product into compliance with the EAEU Rules, provide an applicant with an open-ended registration certificate if a medicinal product has been registered in 3 Member States for 5 years or more. If this criterion is not met, the general rule applies.

Medicinal products registered in accordance with the EAEU Rules and included into the Unified Register are sold within the framework of the Union within the Member States where they are registered.
The procedures established in the EAEU Regulation should replace existing national procedures. The EAEU rules set out the fundamental principles and characteristics of the registration system, but in many cases refer to the national law of Member States, thus leaving room for competition in the sphere of laws and orders.

At present and until December 31, 2020 there is a transitional period, when registration is possible both under national procedure and under EEU rules. After that date, the acceptance of applications under national procedures will cease.

Medicines registered under the national procedure may only be used in the territory of the Member State concerned.  National registration certificates are valid for the entire term, but not later than December 31, 2025. Renewal and amendment of registration dossiers with respect to such certificates may be effected also through national procedure up to the date specified. For further circulation both on the territory of one Member State and on the entire EEU market one must pass the procedure of bringing it into conformity with EEU requirements.