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Russia and Armenia discussed the examination of medicines in the framework of the EAEU rules

Representatives of the Federal State Budgetary Institution “Scientific Center for Expert Evaluation of Medicinal Products” of the Ministry of Health of Russia Ekaterina Rychikhina, Head of the Control and Organizational Department and Konstantin Koshechkin, Head of the Information Management Department, held a working meeting with the staff of the Scientific Center for Drug and Medical Technology Expertise Academician E. Gabrielyana » CJSC.

The experts of the expert institution of the Republic of Armenia were interested in issues related to the formation of a registration dossier in the format of eCTD (general technical document). As well as the experience of Russian colleagues on the reception of the dossier in the framework of compliance with the Rules of the EAEU on the formation and maintenance of a single register of registered drugs of the Eurasian Economic Union.

To exchange information with the resources of the Eurasian Economic Commission in the Republic of Armenia, they plan to use the basic implementation components - an information system created by the ECE for countries that do not have their own information systems for transmitting information about registered drugs to ECE information systems, explains Konstantin Koshechkin. - For our part, we described the actions that need to be taken, both by the applicants and by the regulatory authorities, in order to proceed to work in electronic form.

In addition, during the visit to Yerevan, a series of consultations was held by Armenian experts on the enforcement of the EAEU legislation in relation to the examination and registration of drugs on the procedure for bringing it in line with the requirements of the EAEU. The main issues were related to the requirements for the language of documents submitted only to confirm registration in the territory of the Republic of Armenia.

The issue of confirming the availability of registration of the drug in the EAEU countries for more than 10 years was considered separately, says Ekaterina Rychikhina. - To resolve this issue, a preliminary agreement was reached on the exchange of historical data of state registers.

Russian experts believe that the establishment of direct contacts at the level of practical implementers involved in organizing the examination and registration procedures according to the rules of the EAEU will allow for more efficient building of further interaction in the expert community of the Union member countries.

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