bnt attorneys for CEE close.straight.forward

Launch of Eurasian Economic Union (EAEU) medicines registration procedure

EAEU-level registration opens new possibilities in the single market for medicines.

The first applications have been filed for registration of medicines under the Agreement on unified principles and rules for circulation of medicines within the Eurasian Economic Union (“Agreement”) of 23 December 2014 and the Rules for registration and expertise of medicines for medical use (approved by Decision of the Council of the Eurasian Economic Commission no. 78 of 03.11.2016) (“Rules”).

The Agreement, which came into legal effect on 12 February 2016, requires that medicines allowed on the EAEU market (Armenia, Belarus, Kazakhstan, Kirghizstan, Russia) must first be registered under the Rules and listed in the Unified list of registered medicines of the EAEU. This requirement applies equally to the whole EAEU market and to the territories of individual member states.

Registration under the Rules did not begin immediately after the Agreement came into effect because all necessary second- and third-level documents and technical support were not in place or ready. But as recently as this March and April several announcements were made about the first applications filed under the Rules in Kazakhstan and Belarus. Full-scale launch depends on when the unified integrated information system becomes functional: this is scheduled for the second quarter of 2018.

The unified integrated information system for medicines reflects the key processes of the medicines single market; in particular, it helps to file and process applications in electronic form and facilitates communication between competent authorities.

No single centralised registration is envisaged in the EAEU. Instead, mutual recognition and a decentralized procedure are provided for. Both are conducted on the member-state level by authorised governmental bodies.

These procedures are based on corresponding procedures existing in the EU.

The applicant chooses one state as a reference state which will be responsible for a full-fledged cycle of procedures, including tests and inspections, resulting in an expert report. In other designated states (recognition states) only examination of the expert report from the reference state and particular modules of the uniform technical document takes place.

Under the mutual recognition procedure, registration in the reference state is first completed and then recognition follows. Under the decentralised procedure, both processes happen simultaneously and this is suitable for medicines which are introduced on the EAEU market for the first time.

The set durations for the mutual recognition procedure are up to 210 calendar days in the reference state and up to 90 calendar days in the recognition state. The decentralised procedure should take not more than 210 calendar days. More time may be required for answering additional requests and in the case of other complications.

The Expert Committee for medicines, created within the Eurasian Economic Commission from representatives of all member states, is designed, among other things, to resolve differences between national authorities involved in case recognition is denied.

A registration certificate is issued based on a uniform template in each member state where the medicine has been registered.

Registration in the reference state is valid initially for 5 years. Subject to confirmation of registration (re-registration), a registration certificate can generally be issued for an indefinite term. In the recognition state the validity period is the same as in the reference state.

There is a special procedure for bringing the registration dossiers of medicines registered in the member states before 31 December 2020 into conformity with EAEU requirements. The deadline for completing the procedure is 31 December 2025. The procedure is simplified and takes 100 calendar days. If a medicine is registered in more than one member state, the applicant must choose which one will be the reference state; in other states the registration update will be carried out under the recognition model.

As a result of the procedure, registration is issued for an indefinite term if a medicine has already been registered in 3 member states for 5 years and longer. Should this not be the case, the general rule applies.

Medicines registered under the Rules in particular member states and included in the EAEU Single Register are allowed only on the territory of those states.

The procedures laid down in the Rules will replace corresponding procedures existing now on the national level. However, national legislation will still serve as a regulatory basis for the new procedures as the Rules specify the general features of the system, set main principles and in many matters refer to the national laws of the member states, which therefore allows for jurisdiction shopping.

During the transitional period until 2021 both national and EAEU procedures are available for applicants. After that, national applications will not be accepted.
Medicines registered under national procedure are only allowed on the territory of that particular member state. National registration certificates are valid throughout their validity periods, but no longer than 31 December 2025. Extending the validity of and amending these registrations under national rules is possible within the same timeframe. For a medicine to be allowed on the market of the EAEU or a particular member state beyond that deadline, its dossier must be brought into conformity with EAEU requirements.

Source: http://www.eurasiancommission.org

Subscribe to the newsletter

By pressing Subscribe you consent to our data processing terms