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For import and sale of medicines on the territory of Ukraine it is required to obtain the state registration and fulfil specific requirements regarding quality and safety.\u00a0<\/span><\/p>\n Since 2005, the legislation of Ukraine in relation to the registration and circulation of medicinal products started harmonisation with EU. The general requirements for documentation and expert assessment procedures are similar to the European ones, but there are many national features that significantly affect all regulatory processes.<\/span><\/p>\n The definition of \u201cmedicinal product\u201d includes:<\/span><\/p>\n As of the end of 2019, there are three different registration procedures for medicinal products:<\/span><\/p>\n The Applicant (Marketing Authorization Holder – MAH) can choose the procedure. However, registration under Orders No. 1245 and No. 721 implies certain conditions, and is applicable only to certain groups of medicinal products.<\/span><\/p>\n The MAH for registration can be both a resident and a non-resident of Ukraine (for example, the manufacturer itself). According to the legislation, MAH is responsible for the quality, safety and efficacy of the medicinal product in Ukraine.<\/span><\/p>\n The non-resident MAH is not required to create a representative office or to have another person in Ukraine, however, it is required to:<\/span><\/p>\n MAH\u2019s obligations for regulatory affairs, safety and quality management can be outsourced to Cratia.\u00a0<\/span><\/p>\n \u00a0<\/span><\/p>\n Registration dossier<\/b><\/p>\n The CTD format has been introduced in Ukraine since 2005, and for more than 10 years it has been the only applicable format, with the exception of registration procedures under Orders No. 1245 and No. 721. The CTD format requirements are based on ICH (The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) standards, but the registration dossier is still submitted in paper form.<\/span><\/p>\n The documentation for the standard procedure for a new registration under Order No. 426 includes the following parts:<\/span><\/p>\n The following documents are submitted in the Ukrainian language:<\/span><\/p>\n There are strict requirements for registration dossiers: the number of pages in a file, cross-numbering and table of contents, sidebars etc.<\/span><\/p>\n Administrative documentation is submitted in a properly legalised form. The registration dossier must be submitted in paper form, in some cases parts of the dossier are allowed to be submitted in electronic form.<\/span><\/p>\n <\/p>\n New registration<\/b><\/p>\n Depending on the type of medicinal product, indications for use, market authorisation status and other characteristics, various types of Applications and different expert evaluation periods are used. It should be noted that Ukraine follows the harmonization procedure with the EU, but still has its own independent legislation and expert evaluation procedure.<\/span><\/p>\n Medicines are classified under the following types:<\/span><\/p>\n For each type of a medicinal product, the legislation stipulates certain requirements for the content of the registration dossier, the timing of the expert evaluation and other issues.<\/span><\/p>\n Registration procedure begins with the submission of the Application form to the single-window system of the Ministry of Health, and ends with the signing of the Order of the Ministry of Health and receiving of the hard original Marketing Authorization Certificate.<\/span><\/p>\n Both MAH and competent authority must follow strict timelines as soon as the Application form is submitted. If the MAH does not perform a specific action, or submits the necessary documents not in the full amount, or the documentation is filled incorrectly, then the registration procedure may be canceled, and all paid state fees will not be returned.<\/span><\/p>\n During the registration, it is necessary to make several payments to the accounts of state bodies, including:<\/span><\/p>\n Terms of expert evaluation of the registration dossier for a medicinal product depending on the type of Applications and chosen registration route:<\/span><\/p>\n The indicated timelines are duration of expert evaluation of materials, and do not include:<\/span><\/p>\n The realistic timelines of the registration procedure includes the expert evaluation period, plus several months for the mentioned actions.<\/span><\/p>\n \u00a0<\/span><\/p>\n Language and labeling<\/b><\/p>\n The only official language in Ukraine is Ukrainian. Suggested text for labeling and instructions for use (leaflet, package insert) of the medicinal product are submitted for expert evaluation in Ukrainian language.<\/span><\/p>\n The labeling information and instructions for use are assessed during the state registration and approved as the annexes to the registration certificate. During the expert evaluation the text may be amended repeatedly at the discretion of state experts. Other languages \u200b\u200b(for example, Russian, English) may also be presented on the packaging and in the instructions provided the complete identity of the text to the Ukrainian text.<\/span><\/p>\n After receiving a Marketing Authorization, but before importing the medicinal product, the Applicant should develop graphic packaging mock-ups and submit them for registration to the Unified Automated Information System (UAIS) of the State Service of Ukraine on Medicines and Drugs Control.<\/span><\/p>\n Layouts submitted for registration should include:<\/span><\/p>\n The packaging of a medicinal product is checked at the stage of import of the batch (obtaining an opinion on the quality of the imported batch), and the slightest discrepancy can lead to deficiency letter, suspension of the quality conclusion issuance and corrective actions.<\/span><\/p>\n Exceptions are medicinal products purchased by specialized international organizations, which are allowed to be supplied in packaging labeled in the original language.<\/span><\/p>\n \u00a0<\/span><\/p>\n Marketing Authorization<\/b><\/p>\n Marketing Authorization after the initial registration is issued for a period of 5 years. After renewal, an unlimited Marketing Authorization is issued (unless the Ministry of Health decides to conduct additional renewal after 5 years for justified reasons related to pharmacovigilance).<\/span><\/p>\n Marketing Authorization consists of:<\/span><\/p>\n All amendments (of any type) are also an integral part of the Marketing Authorization.<\/span><\/p>\n <\/p>\n Maintenance of Marketing Authorization and changes<\/b><\/p>\n In Ukraine there are no monthly or annual payments related to maintaining registration. However, the Applicant must maintain a pharmacovigilance system and a quality management system in Ukraine.<\/span><\/p>\n Therefore, the Applicant must provide:<\/span><\/p>\n Fulfillment of the Applicant’s obligations with regard to maintaining quality and safety may be outsourced to Cratia Ltd.<\/span><\/p>\n All changes to the Marketing Authorization are made by submitting the Application and a package of documents, payment of the cost of expert evaluation, approval by the Order of the Ministry of Health of Ukraine.<\/span><\/p>\n The Applicant must submit an Application for Variations related to safety to the instructions for human use of a medicinal product within the 60 calendar days from the date of receipt of information on amendment necessity.<\/span><\/p>\n The types of variations are similar to those in the EU:<\/span><\/p>\n The concept of \u201cnotification\u201d in Ukraine differs from European practice: in fact, \u201cnotification\u201d changes do not imply any errors or questions of the competent authorities, since a comment means refusal to conduct an expert evaluation.<\/span><\/p>\n <\/p>\n Marketing Authorization Renewal<\/b><\/p>\n It is possible to submit an Application for renewal of\u00a0 marketing authorization not later than 180 calendar days before its expiry (the recommended period for application is 12 months).<\/span><\/p>\n Renewal process starts from the moment the Application is submitted to the Ministry of Health of Ukraine, and ends by approving the renewal of the authorization by the Order of the Ministry of Health of Ukraine and the issuance of a new Marketing Authorization. In this case, the Marketing Authorization number remains the same.<\/span><\/p>\n \u00a0A significantly smaller package of documents is required for renewal procedure compared to an initial registration. During renewal process, the main emphasis is made on the managing medicinal product safety, i.e., on the pharmacovigilance system documentation and instructions for human use of the medicinal product.<\/span><\/p>\n Before filing the Renewal Application, it is necessary to submit separate Applications for all changes. Such submitted Applications (variations and renewal) undergo expert evaluation concurrently and independently.<\/span><\/p>\n Once renewed, the Marketing Authorisation shall be valid for an unlimited period, unless the Ministry of Health decides to conduct additional renewal procedure after 5 years on justified reasons relating to pharmacovigilance.<\/span><\/p>\n <\/p>\n Cratia provides professional services on establishment and maintenance of state registration of medicines in Ukraine. We have an excellent knowledge of national legislation, necessary experience and resources.\u00a0\u00a0<\/b><\/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":0,"parent":124,"menu_order":1,"template":"","class_list":["post-419","countries","type-countries","status-publish","hentry"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/countries\/419","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"}],"up":[{"embeddable":true,"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/countries\/124"}],"wp:attachment":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/media?parent=419"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n
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