Russia & EAEU Launch Common Regulated Pharma Market

Posted on by

russian-drugsThe Eurasian Economic Union has ratified a regulatory framework for medicines circulation in the EAEU. According to Member of the Board – Minister of the Eurasian Economic Commission (EEC), Valery Koreshkov, “National medicines markets of the five Member States of the Eurasian Economic Union (EAEU) [will] unify and start operating in the format of a single space”. “Manufacturers of the Union countries will be able to apply for registration of medicines and their release under common procedures and reduce administrative costs.”

An average consumer will notice changes in the pharmaceutical market over time – it currently takes seven to ten months from the moment of filing a drug application for approval to releasing the drug into circulation and its sale. The new regulations will improve this administrative process once the drugs have been cleared for distribution.

The supranational regulations of the common market will be used for development, pre-clinical and clinical study, quality control, registration, manufacture, and distribution of medicines. “The Commission, together with the best experts from the five Member States of the EAEU, has prepared all the necessary documents for the effective operation of the common medicines market, taking into account global practice,” Valery Koreshkov said. “They are aimed at removing administrative barriers in manufacture and approval of medicines for circulation in the markets of the Union countries. These documents will also provide a distinctive “sanitization” of the pharmaceutical market, removing from it medicines, the efficacy and safety of which is not fully studied, but manufacture does not conform to the standards of good manufacturing practices.”

Matters related with the administration of approvals issued for preclinical and clinical studies of medicines, pricing of medicines and medical products, retail trade, public procurement of medicines, other procedures related to cost recovery in the circulation of medicines, and the regulation of medical advertising have been left at the level of national regulation.

A transitional period ensuring a smooth transition from national to common regulation is provided for. This will prevent bad performance of health systems in the EAEU countries, and help manufacturers of medicines to adapt to the new requirements as comfortably as possible. In particular, till December 31, 2020, the manufacturer has the right to choose under what regulations (national or common) it registers its medicines. All medicines registered under national regulations till December 31, 2020 should pass re-registration under the regulations of the common market before December 31, 2025. When filing a drug application for registration before December 31, 2018, the manufacturer may provide national documents issued by the Union Member States that confirm compliance of manufacture of medicines with the requirements of national GMP instead of a GMP certificate of the EAEU.

“These new regulations have implications for foreign drug manufacturers” says Chris Devonshire-Ellis of Dezan Shira & Associates. Indian drug companies should especially take note, as well as the Chinese TCM market as both these countries are negotiating to have Free Trade Agreements with the EAEU. Now is a good time to be analyzing this market and preparing for the new opportunities that the standardization of EAEU Pharmaceuticals industry will bring”

 

Chris Devonshire-Ellis is the Founding Partner and Chairman of Dezan Shira & Associates. He is based in Europe. The firm provides European businesses and governments with strategic, legal, tax and operational advisory services to SMEs and MNCs investing throughout Asia and has 28 offices across China, India and the ASEAN nations as well as St. Petersburg and Moscow. Please contact the firm at russia@dezshira.com or visit the practice at www.dezshira.com

 

related-readings_rb-icons_2017 Related Reading:

Assisting Foreign Investors into Russia

Dezan Shira & Associates´ Russian investment brochure offers an overview of the services provided by the firm – both foreign investment into Russia and Russian investment into Asia. It is Dezan Shira´s mission to guide investors through Russia´s complex regulatory environment and assist with all aspects of establishing, maintaining and growing business operations in the region.


Establishing a Foreign Business in Russia

In this issue of Russia Briefing, we explain the basics of business set up for foreign investors, from trademark registration, representation, trading mechanisms, and manufacturing. With low corporate tax rates, Russia is set to become the most dynamic of the trade corridors opening up to Asia.


Customs Union, Certification and Import

In this issue of RUSSIA BRIEFING, we take a close look at the import and export procedures into, out of, and within the Russia, Belarus and Kazakhstan Customs Union. We then look at the current situation one year after Russia’s WTO accession. Next we look at issues of product certification and VAT procedures in the Customs Union. Finally, we explain the processes involved with the import of goods between affiliate companies.

 

Leave a Reply

Your email address will not be published. Required fields are marked *

Dezan Shira & Associates

Meet the firm behind our content. Dezan Shira & Associates have been servicing foreign investors in China, India and the ASEAN region since 1992. Click here to visit their professional services website and discover how they can help your business succeed in Asia.

Never Miss an Update

Subscribe to gain even better insights into doing business in Russia. Subscribing also lets you to take full advantage of all our website features including customizable searches, favorite, wish list and gift functions and access to otherwise restricted content.

Scroll to top