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According to the Law of the Republic of Belarus \u201cOn medicinal products\u201d, import and sale of medicines in Belarus are allowed only after state registration (confirmation of state registration). Both finished medicinal products and active pharmaceutical ingredients are subject to registration.<\/span><\/p>\n The Registration Certificate is issued in the name of the Applicant (Marketing Authorization Holder – MAH) that can be both a resident and a non-resident of the Republic of Belarus.<\/span><\/p>\n Expert evaluation during registration of finished medicinal products and active pharmaceutical ingredients is performed by the Unitary Enterprise \u201cCenter for Expert Evaluation and Testing in Health Care\u201d of the Ministry of Health of the Republic of Belarus (website: <\/span>http:\/\/www.rceth.by\/<\/span><\/a>).\u00a0<\/span><\/p>\n Registration of medicinal products may be performed under the \u201cnational\u201d procedure until 31 December 2020, or under the \u201ccentralized\u201d procedure; and only under the “centralized” procedure of the EAEU after 31 December 2020.<\/span><\/p>\n The procedure for national registration is described below. You can get information about registration under the EAEU\u2019s unified rules by clicking on the link<\/a>.<\/span><\/p>\n The national registration procedure in Belarus follows a “general” or “simplified” route. Registration under the \u201csimplified\u201d route is available for medicines registered in countries with high regulatory standards.\u00a0<\/span><\/p>\n <\/p>\n Simplified state registration<\/b><\/p>\n Starting from 31 December 2019, Presidential Decree No. 499 “On Circulation of Medicines” approved medicines that are subject to state registration in a simplified procedure:<\/span><\/p>\n Procedure of specialized assessment of registration materials under \u201csimplified\u201d procedure should not exceed 30 working days. State fees for the “simplified” registration procedure are also decreased.\u00a0<\/span><\/p>\n <\/p>\n National registration by \u201cgeneral\u201d route\u00a0<\/b><\/p>\n The procedure for national state registration of medicinal products was approved by Law No. 161-3 \u201cOn medicinal products\u201d and Resolution No. 156 \u201cOn approving the consolidated list of administrative procedures\u201d with amendments dated July 28, 2018.<\/span><\/p>\n Belarus is a country with high standards of regulation of marketed medicinal products. Inconsistencies between approved and actual packaging layouts, instructions for use and (or) package leaflets, quality certificates may cause rejection of the medicinal product and temporary or permanent prohibition on sales.<\/span><\/p>\n The registration dossier is accepted both in the national and in the CTD format. Regardless of the format of the registration dossier, it is necessary to develop specific national documents, namely:<\/span><\/p>\n The last update of Regulation No. 52 introduced special requirements to validation documents, specifications and Normative document (ND), confirmation of copies of provided reports on drug stability, documents of the substance manufacturer and many others were put forward. The main peculiarity of requirements to a set of documents is provision of a certified copy of the contract between an applicant and a manufacturer of a medicinal product (in case of their difference).\u00a0\u00a0<\/span><\/p>\n The dossier is submitted in paper form, the possibility of filing the dossier in electronic form is not available.<\/span><\/p>\n Part of the documentation must be submitted with translation into Russian or Belarusian. Part of the administrative documentation must be submitted according to the requirements for international legalization of documents.<\/span><\/p>\n The stages of the registration procedure may be presented as follows:<\/span><\/p>\n The period of expert activities for state registration of the medicinal product is 6 months.\u00a0 A crucial point is that absolutely all activities must be completed within 6 months, including the expert evaluation of the documentation and the responses to observations, laboratory analysis of samples, inspection of the manufacturing site.<\/span><\/p>\n <\/p>\n Inspection of manufacturing site\u00a0<\/b><\/p>\n The procedure for inspection of manufacturing site is approved by Resolution No. 72 \u201cOn approval of instruction on cases and procedure for inspection of industrial production of medicinal products\u201d dated May 14, 2015.<\/span><\/p>\n Inspection is required during the first state registration of the site.<\/span><\/p>\n Inspection is carried out by a group of state experts. The Applicant of registration pays for the cost of the inspection activities, as well as transport and accommodation expenses.<\/span><\/p>\n The results of the inspection are valid for 5 years.<\/span><\/p>\n <\/p>\n Language and labeling<\/b><\/p>\n The package labeling, instructions for use and (or) package leaflet are submitted and approved in Russian or Belarusian. According to Resolution of the Ministry of Health of the Republic of Belarus dated May 5, 2009 No. 52 \u201cOn the requirements to the documents submitted for state registration\u2026\u201d (with amendments dd 05.11.2019), MAH has the choice of the language.\u00a0<\/span><\/p>\n Registration certificate includes approved text of the instruction for use (or package leaflet) and color package artworks (mock-ups).\u00a0<\/span><\/p>\n The Registration Certificate<\/b> is issued for a period of 5 years after the first registration, and indefinitely after renewal of registration. The medicinal product that has been placed on the market during the validity of the Registration Certificate validity is allowed to sale until the expiration date.\u00a0<\/span><\/p>\n <\/p>\n The Registration Certificate consists of:<\/b><\/p>\n <\/p>\n Variations<\/b><\/p>\n According to the national legislation, the Application for variations should be submitted within three months from the date of approval by the competent authority of the manufacturing country (if this variation requires approval or notification procedure).\u00a0<\/span><\/p>\n Variations to the registration dossier should be applied in the following cases:<\/span><\/p>\n <\/p>\n Renewal of registration<\/b><\/p>\n Application for renewal should be submitted not later than 3 months before expiry of the registration certificate. The renewal procedure is similar to the new registration.<\/span><\/p>\n In-renewal quality control of the samples can be required in case of changes in the Specification and\/or control methods of the finished product. Inspection of the manufacturing site can be required.\u00a0<\/span><\/p>\n The period of expert evaluation should not exceed 6 months.\u00a0<\/span><\/p>\n The Registration certificate without expiry will be issued based on the positive decision of the expert evaluation of renewal procedure.\u00a0<\/span><\/p>\n <\/p>\n Cratia provides professional services of state registration (renewals, variations) of medicinal products in Belarus. We have an excellent knowledge of national legislation, necessary experience and resources.\u00a0<\/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":0,"parent":142,"menu_order":1,"template":"","class_list":["post-354","countries","type-countries","status-publish","hentry"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/countries\/354","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\/142"}],"wp:attachment":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/media?parent=354"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n
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