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What awaits pharmaceutical manufacturers in the united EAEU market?

Almost two years have passed since the pharmaceutical markets of the five countries of the Eurasian Economic Union (EAEU) merged. However, there are still issues to be resolved. Among them - the harmonization of national legislation, as well as the upcoming re-registration of medicines according to the rules of the common market. Gedeon Richter shared its experience in the EAEU countries and spoke about its contribution to the formation of a single economic space.

The decision to form a common pharmaceutical market in the EAEU countries was officially announced on May 6, 2017. Since then, participants in the economic space have been actively working to improve their legislation to ensure unhindered circulation of medicines. Instructions for the use of drugs will be the same for all the states of the EAEU, which will allow them to be released centrally not for the needs of a particular country, but for the entire Union.

Dr. Attila Varadi, plenipotentiary representative of Gedeon Richter in Russia:

“We were one of the first foreign companies taking an active part in the development of the Russian pharmaceutical market, and we are glad that we are now also actively involved in the development of the Eurasian market. We believe that this is a very good initiative that will make the modern quality of treatment more accessible, for example, to Armenia or Kyrgyzstan. After all, large companies are often unprofitable to produce small batches of drugs with specific requirements that exist in each country. It is much more expedient to do this for a larger region with uniformed requirements. Understanding this, we are working to expand the Russian plant in the Moscow region, in order, among other things, to arrange production of drugs in a volume that can meet the needs of patients of the EAEU countries. ”

Despite the fact that, at the level of national regulation, there are questions of issuing permits for preclinical and clinical studies, pricing, and public procurement, there are aspects that will be the same for everyone. Among them is the registration of medicines. So, until December 31, 2020, the manufacturer has the right to choose which rules he will submit the registration dossier - national or EAEU rules. But all drugs that were registered under the national procedure will have to be reregistered according to the laws of the single market before the end of 2025.

Natalya Volovich, Deputy Director, Head of the Registration Department of the Representative Office of Gedeon Richter (Hungary), Moscow:

“We became one of the first companies who submitted an application for registration of drugs according to the Eurasian procedure in Belarus and Kazakhstan. As soon as the process is launched, we will do it in Russia. In addition, we continue to register our new products according to national procedures also. This allows us to better understand all legislative subtleties and bring up the most relevant and close to reality issues for discussion. For example, in Russia, before submitting a registration dossier, there is a mandatory requirement - conducting local clinical trials, and this rule is well known to all market participants. In Belarus, at the application stage, it is not clear whether research is required or not. This fact can be clarified already when the company has prepared everything and is ready to bring the drug to the market. Today it is important that national legislation be harmonized as much as possible with the regulatory norms of the EAEU.”

Representatives of the company also noted that today the work of the pharmaceutical business is actively moving towards digitalization: if before the registration dossier was a folder with paper documents, now it is possible to use electronic media, which makes the process more efficient and transparent. Another interesting innovation that will bring about the beginning of a full-fledged operation of the unified market will be changes in instructions for use.

Natalia Volovich:

“Today in Russia there is a single instruction for use of the drug for both the patient and the doctor, in which, for example, it is rather difficult for a non-specialist to be guided. With the start of the EAEU market, there will be two such documents. The first is for health care professionals, which will contain narrow medical information and be posted on the websites of regulatory authorities. The other is for the patient, with available information about the drug, its side effects, the rules for taking it, and its compatibility with other medicines, products or drinks. This will allow both doctors and those who are prescribed the drug to receive available and relevant information. ”

The top managers of Gedeon Richter also noted that the company is ready to further assist in the development of the single pharmaceutical market of the EAEU, making it more transparent and patient-oriented.

Some facts about the EAEU member countries:

• Since March 2019, the Ministry of Health of the Republic of Kazakhstan has been vested with the competence to regulate the prices of all medicines. Large-scale digitalization is underway in this country, and therefore, already since 2020, prescription drugs are planned to be transferred to electronic format.
Belarus is developing measures to reduce the registration of drugs and modernize production in order to increase export potential by 50%: by 2022, half of all manufactured medicines in the Republic should go abroad
In Armenia, only 10% is produced domestically, and 90% of essential medicines are imported, and the situation is unlikely to change anytime soon.
In Kyrgyzstan, the cost of medicines is not yet regulated by the state, so the same drug in different pharmacies costs differently, and this difference can be significant. But at the end of 2018, the Department of Health almost completed the price analysis and now plans to determine the maximum allowable rates of surcharges in wholesale and retail
In Russia, from January 1, 2020, labeling of all medicines circulating in the country becomes mandatory.

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