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Common market for medicines and medical devices in the Eurasian Economic Union

Belarus: A common market for medicines and medical devices is developing in Belarus, Russia, Kazakhstan, Kyrgyzstan, and Armenia.

The common market for medicines and medical devices will start operating from 1 January 2016.

As a result, a unified approach to regulation of circulation of medicines in the Eurasian Economic Union (the Union or the EAEU) is under development. At the same time, harmonization of EAEU member-state pharmaceutical legislation is also under way.

The Agreement on Common Principles and Rules for Circulation of Medicines within the Eurasian Economic Union and the Agreement on Common Principles and Rules for Circulation of Medical Devices within the Eurasian Economic Union signed on 23 December 2014 are aimed at establishing a common market for medicines and medical devices.

On the basis of these Agreements, the following policies are being developed):
• general requirements for safety and effectiveness of medicines and medical devices;
• rules for registration of medical devices and rules for examination of their safety, quality, and efficacy;
• rules for registration and examination of medicines;
• rules for classifying medical devices;
• requirements for labeling medicines and rules for keeping medicine lists (nomenclatures);
• rules of good practice in producing and distributing medicines (there are about 40 documents on medicines and medical devices).

Development of general requirements as to quality and safety aims to create harmonized conditions for product circulation on the common market, while development of rules for registration and examination targets eliminating differences in registration procedures in each of the EAEU member states.

According to the current draft rules, registration will be carried out by the competent authorities of the EAEU. The rules enable medicinal registration under sequential procedure (mutual recognition procedure) and simultaneous procedure (decentralized registration procedure) at the discretion of the applicant.

The term “referential state” has been introduced: this is the member state to whose competent authority the application was submitted. The original registration in the referential state (national registration) may be extended to other member states through the mutual recognition procedure.

The decentralized registration procedure is carried out by several member states with the choice of the referential state. The applicant independently selects the referential state when applying for registration of medicine (i.e., when there is no registration in any member state of the EAEU).

The period of validity of a Registration Certificate issued for the first time is five years. After the Registration Certificate expires, it is necessary to confirm registration (reregister) of the medicine. After that, the Registration Certificate is issued for an indefinite period.

As for medical devices, the draft rules do not set a decentralized registration procedure. Registration of medical devices will be carried out by the referential state in other states under the subsequent recognition procedure. Thus, a single supranational authority responsible for registration and examination of medicines and medical devices will not be established.

The plan is to develop a common EAEU pharmacopoeia. Before approval, the pharmacopoeia of the member states will be applied taking into account the provisions of agreements already adopted in the EAEU.

Common packaging layouts with translation into member state national languages will be introduced in the EAEU. A special product circulation mark will be applied to medical devices. The applicant will be obliged to apply the product circulation mark to all medical devices registered under the procedure established in the EAEU.

An additional plan is to create a united information system to facilitate and coordinate cooperation between the competent member state authorities, as well as timely provision of information to interested persons.

Pharmaceutical terminology will be aligned: previously, this differed significantly among member states. To prevent differences in interpreting certain terms, a Unified Handbook regulating basic terms will be introduced in the EAEU.

All documents should be developed and adopted by the Eurasian Economic Commission before 1 January 2016.

Note that if a medicine is registered before 1 January 2016, it would be necessary to align it with the general requirements on the expiry of 10 years from the date of registration. For medical devices, the draft rules set a term of five years.

Source: Official website of the Eurasian economic commission http://eec.eaeunion.org/