{"id":402010,"date":"2022-03-31T12:56:28","date_gmt":"2022-03-31T09:56:28","guid":{"rendered":"https:\/\/eba.com.ua\/?p=402010"},"modified":"2022-03-31T20:53:31","modified_gmt":"2022-03-31T17:53:31","slug":"vprovadzhennya-elektronnogo-formatu-dlya-usih-reyestratsijnyh-protsedur-na-liky-ye-vkraj-krytychnym","status":"publish","type":"post","link":"https:\/\/eba.com.ua\/en\/vprovadzhennya-elektronnogo-formatu-dlya-usih-reyestratsijnyh-protsedur-na-liky-ye-vkraj-krytychnym\/","title":{"rendered":"[:ua]\u0412\u043f\u0440\u043e\u0432\u0430\u0434\u0436\u0435\u043d\u043d\u044f \u0435\u043b\u0435\u043a\u0442\u0440\u043e\u043d\u043d\u043e\u0433\u043e \u0444\u043e\u0440\u043c\u0430\u0442\u0443 \u0434\u043b\u044f \u0443\u0441\u0456\u0445 \u0440\u0435\u0454\u0441\u0442\u0440\u0430\u0446\u0456\u0439\u043d\u0438\u0445 \u043f\u0440\u043e\u0446\u0435\u0434\u0443\u0440 \u043d\u0430 \u043b\u0456\u043a\u0438 \u0454 \u0432\u043a\u0440\u0430\u0439 \u043a\u0440\u0438\u0442\u0438\u0447\u043d\u0438\u043c[:en]The introduction of e-registration for drugs is extremely critical[:]"},"content":{"rendered":"

<\/p>\n

The EBA Health Care Committee appeals to the Cabinet of Ministers of Ukraine, the Ministry of Health of Ukraine, the State Expert Centre of the Ministry of Health of Ukraine to implement as soon as possible solutions that will ensure uninterrupted registration and re-registration of medicines and changes to registration materials. Digitalization of processes will be advisable given martial law. Unfortunately, not yet all registration procedures have been translated to electronic form. And the availability of medicines on the territory of Ukraine directly depends on the ability to conduct all types of registration procedures in a timely and correct manner.<\/p>\n

Business knows about the stressful work regime of the Cabinet of Ministers, the Ministry of Health and the SEC due to the war. Also, we are sincerely grateful to the authorities for implementing in law and practice a range of measures to support the pharmaceutical sector that also reflect the proposals made by the Committee<\/a><\/strong>. Thus, some regulatory and supervisory procedures are now simplified which maintain the sustainable functioning of the sphere.<\/p>\n

Meanwhile, the objective inability of the applicants to carry out registration procedures in paper format by physically submitting materials to the Ministry of Health and the SEC (Kyiv) is currently a critical issue. Unfortunately, this is not possible for many pharmaceutical companies: many workers have been forced to leave their homes, some serve in the army or volunteer; company offices work remotely. As a result, resources are severely limited.<\/p>\n

However, registration procedures still need to be kept up to date. First, for the safety of patients because information about the drug must be relevant. Secondly, for the continued supply of medicines to the territory of Ukraine as a whole. After all, the stable and timely conducted registration procedures ensure the “legitimate” supply of medicines to the country and its territory.<\/p>\n

Currently, maintaining registration procedures for drugs under martial law requires flexible solutions from public authorities. The only safe and physically possible way to carry out such procedures is for applicants to submit all documents and materials in electronic format, and for unconditional acceptance by the Ministry of Health and the SEC, of electronic signatures, scanned copies of documents, and receipt of materials from applicants through cloud storage (with access provided to experts, etc). Besides, some of these solutions have been temporarily used in practice since the beginning of the COVID-19 pandemic and the first lockdowns.<\/p>\n

The European Business Association is grateful that the Ministry of Health understands the situation and tries to help resolve it. Also, for its part, the SEC announced the adoption of electronic applications, materials on clinical trials of medicines and approval of significant amendments to clinical trial protocols. However, the approach to applicants should not be selective. Applicants for finished medicines need a similar solution for all registration procedures without exception.<\/p>\n

The EBA draws attention to the thorough assessment of the risks that are increasing day by day due to the inability to start \/ continue or complete certain registration procedures remotely, through electronic interaction between applicants and the expert body. These processes directly affect the continuation of drug sales and providing patients with up-to-date information. Besides, restrictions may block the circulation of certain drugs because of the circumstances out of control of the applicant \u2013 a company is not able to physically submit documents within the prescribed time.<\/p>\n

We hope that the cohesion and unity shown by Ukraine in its response to the aggressor will also be reflected in the joint and effective decisions of the authorities, patients and the pharmaceutical community \u2013 in favour of a stable supply of medicines. Glory to Ukraine!<\/p>\n

<\/p>","protected":false},"excerpt":{"rendered":"

The EBA Health Care Committee appeals to the Cabinet of Ministers of Ukraine, the Ministry of Health of Ukraine, the State Expert Centre of the Ministry of Health of Ukraine to implement as soon as possible solutions that will ensure uninterrupted registration and re-registration of medicines and changes to registration materials. Digitalization of processes will […]<\/p>\n","protected":false},"author":23406,"featured_media":402023,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,13],"tags":[],"yoast_head":"\nThe introduction of e-registration for drugs is extremely critical - European Business Association<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/eba.com.ua\/vprovadzhennya-elektronnogo-formatu-dlya-usih-reyestratsijnyh-protsedur-na-liky-ye-vkraj-krytychnym\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The introduction of e-registration for drugs is extremely critical - European Business Association\" \/>\n<meta property=\"og:description\" content=\"The EBA Health Care Committee appeals to the Cabinet of Ministers of Ukraine, the Ministry of Health of Ukraine, the State Expert Centre of the Ministry of Health of Ukraine to implement as soon as possible solutions that will ensure uninterrupted registration and re-registration of medicines and changes to registration materials. 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