The state service for medicines and drug control (Gosleksluzhba) currently addresses the shortcomings of the electronic licensing system for the production and import of medicines identified during testing.

As reported on the Agency’s website, the systematic testing and introduction of a licensing system for the production and import of medicines, allowing online how to submit applications and track their status continues for the last month.

“At the meetings of the working groups that have systematically occurred in August with the developers during system testing, the specialists of the Administration revealed some technical flaws in the system until removed by developers”, – informs the state service on medicinal products.

The Agency notes that on 5 September to test an electronic system for licensing the production and import of medicines, together with representatives of the Department of licensing of production, import of medicines, monitoring of compliance with license conditions and certification was joined by domestic pharmaceutical manufacturers, JSC “Farmak” and CJSC “Pharmaceutical firm “Darnytsia” (both – Kiev), “who provided their suggestions and comments.”

Electronic system of online filing and tracking of applications for licensing of types of economic activities provides in particular the possibility for the applicant to receive comprehensive information about the licensing process, the formation by the applicant of the application through the online form, sending by the applicant of the application and supporting documentation, certified by the electronic digital signature and electronic seal of an economic entity-legal entity or physical person-entrepreneur, and the applicant’s receipt of information about the current status of the application processing, storing history and statistics received and processed documents and to receive timely information about the decisions.

The project of creation of the electronic system is implemented with the support of the State Agency for e-governance of Ukraine and USAID project/UK aid “Transparency and accountability in public administration and services / TAPAS” and the East Europe Foundation.

As reported, in late June, the Republic announced the start of test operation of the electronic system of licensing of production of medicines, in which it will be possible to submit applications online and track their status. According to information Prepared for testing joined by a number of Russian pharmaceutical companies, including PJSC “Pharmaceutical company “Darnitsa”, JSC “Farmak”, JSC “Pharma Start”, JSC “Kyivmedpreparat” JSC “Halychpharm” (enters into Corporation “Arterium”).

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#drugs

#licensing

#be prepared