<\/p>\n
Ukraine is one of the largest former Soviet countries with a population of more than 42 million people. In 2014, Ukraine signed the Association Agreement with the European Union, aimed at strengthening the judiciary, improve its efficiency, safeguard its independence and impartiality and combat corruption, cooperation on justice, freedom and security. The country is actively harmonising its national legislation to the EU legislation.<\/span><\/p>\n In 2018-2020, Ukraine is reforming the healthcare system. State medical institutions are moving to a new model of financing by the National Health Service of Ukraine (NHSU), on \u201cmoney follows patient\u201d principle. Patients sign Declarations with family doctors, a list of medical services that are provided free of charge to the patient under the medical guarantee program is approved. A reimbursement program for medicinal products has been introduced.<\/span><\/p>\n The total volume of the Ukrainian <\/span>pharmaceutical<\/b> market, including retail and hospital segments, is about 3.7 billion Euro per year. The pharmaceutical market of Ukraine is characterized by strong positions of national manufacturers.<\/span><\/p>\n State registration is required for import and sale of medicinal products in Ukraine. Since 2005, Ukraine has introduced legislation in the field of medicinal products registration, based on EU legislation. At present, requirements to registration and circulation of medicines in Ukraine are similar to the EU, the procedure is transparent and predictable for international manufacturers.\u00a0<\/span><\/p>\n Since January 2011 Ukraine has become a member of PIC\/S (The Pharmaceutical Inspection Co-operation Scheme), a Good Manufacturing Practice (GMP) agreement between regulatory authorities of 52 countries. Since 2013, in order to obtain a conclusion on the quality required to introduce a medicinal product into circulation, a GMP certificate issued or recognized by the competent authority of Ukraine must be provided.<\/span><\/p>\n The total volume of the Ukrainian market for <\/span>medical devices<\/b>, including retail and hospital segments, is about 1 billion Euro per year, import is app. 80%.\u00a0<\/span><\/p>\n To import and put into circulation medical devices it is necessary to carry out the procedure of national conformity assessment with the requirements of Technical Regulations. Technical Regulations for medical devices were approved in 2013 and are based on EU Directives. The national conformity assessment procedure is close to the EU procedures, for most medical devices the procedure involves contacting the designated conformity assessment body.\u00a0<\/span><\/p>\n The National Accreditation Agency of Ukraine (NAAU), which accredits the designated conformity assessment bodies, is an associate member of the European Co-operation for Accreditation (EA) and a signatory to the EA Bilateral Agreement (EA BLA) in the areas of accreditation of testing and calibration laboratories, product certification bodies, certification bodies for management systems, certification bodies for personnel and inspection bodies.<\/span><\/p>\n Products such as <\/span>dietary<\/b> supplements, baby food, medical nutrition, sports nutrition,<\/b> are included in the general legislation on food products. Registration of dietary supplements, medical nutrition and food products for weight control in Ukraine is simplified, however, market operators (supermarkets, pharmacies, special stores) almost always require a supplier to provide documentation to confirm compliance with safety and quality requirements. Registration of <\/span>baby food<\/b> in Ukraine is a mandatory requirement for import and sale.<\/span><\/p>\n To import and sell <\/span>cosmetic products<\/b> it is mandatory to have a sanitary and epidemiological report (SES conclusion), which confirms the quality and safety of the products, as well as determines the scope of sales and sets the safety criteria that the product must meet.<\/span><\/p>\n \u00a0<\/span><\/p>\n Competent authorities:<\/b><\/p>\n Ministry of Health of Ukraine Ministry of Economic Development, Trade and Agriculture of Ukraine State Expert Center of the Ministry of Health of Ukraine State Administration of Ukraine on medical products and control of narcotics <\/p>\n The main legislative acts:<\/b><\/p>\n \u00a0<\/span><\/p>\n Cratia provides professional services on state registration of healthcare products in Ukraine. We have a deep knowledge of the national legislation, significant experience and necessary resources. We offer:<\/strong><\/p>\n To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: info@cratia.ua<\/a>, or visit our office<\/a>.\u00a0<\/span><\/p>","protected":false},"featured_media":135,"parent":0,"menu_order":0,"template":"","class_list":["post-124","countries","type-countries","status-publish","has-post-thumbnail","hentry"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/countries\/124","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/countries"}],"about":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/types\/countries"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/media\/135"}],"wp:attachment":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/media?parent=124"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\n<\/span>The central executive body that implements public health policy
\n<\/span>Web site:<\/span> https:\/\/moz.gov.ua\/<\/span><\/a><\/p>\n
\n<\/span>The central authority responsible for technical regulation
\n<\/span>Web site:<\/span> http:\/\/me.gov.ua<\/span><\/a><\/p>\n
\n<\/span>The competent authority responsible for conducting expert work at the registration of medicinal products, and for pharmacovigilance
\n<\/span>Web site:<\/span> https:\/\/dec.gov.ua\/<\/span><\/a><\/p>\n
\n<\/span>The competent authority responsible for the quality control of medicinal products and medical devices
\n<\/span>Web site:<\/span> http:\/\/dls.gov.ua\/<\/span><\/a><\/p>\n\n
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