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The procedure for state registration of medicinal products is regulated by the Law of the Republic of Mongolia \u201cOn medicinal products and medical devices\u201d and Order of the Ministry of Health of Mongolia No. 13 dated January 15, 2015 \u201cOn approval of the provision on registration of medicinal products and substances\u201d.<\/span><\/p>\n An important peculiarity of the market is that <\/span>only a resident of the country can act as a Marketing Authorisation Holder<\/b>: <\/span>an official representative of a foreign manufacturer in Mongolia or a national distributor who has a contract with the manufacturer for the registration of medicinal products<\/span><\/i>.<\/span><\/p>\n We recommend to investigate and consider a number of factors prior to start of the state registration of the medicinal product in Mongolia:\u00a0<\/span><\/p>\n and other factors.<\/span><\/p>\n <\/p>\n Registration dossier<\/b><\/p>\n Registration dossier is prepared in accordance with national specific requirements. The format of the dossier is national and significantly differs from the CTD format.<\/span><\/p>\n There are a number of important peculiarities that must be taken into account when preparing the Application and registration dossier for Mongolia, such as:<\/span><\/p>\n * – not required for expedited registration procedure.<\/span><\/p>\n The Application and the registration dossier shall be submitted in paper form, signed and sealed by the manufacturer where required, as well as by his representative. The dossier shall be submitted in several copies, one of which is \u201cfor archive\u201d.<\/span><\/p>\n Certain parts of the registration dossier shall be submitted in Mongolian language.\u00a0<\/span><\/p>\n Samples and reference standards will be required in order to carry out intra-registration quality control.<\/span><\/p>\n Manufacture of a medicinal product shall conform to the GMP requirements. However, the legislation of Mongolia does not impose special requirements on the competent authority that issued the certificate of compliance with the standard of good manufacturing practice.<\/span><\/p>\n Registration of medicinal products is performed by the standard or by the fast-track procedure.<\/span><\/p>\n <\/p>\n Fast-track registration procedure<\/b><\/p>\n The fast-track registration procedure is applicable for medicinal products registered in countries with high regulatory standards and registration of which is necessary in the interest of healthcare in Mongolia.<\/span><\/p>\n There are two types of fast-track registration procedures in Mongolia:\u00a0<\/span><\/p>\n Duration of registration for type \u201cA\u201d is 30 days, for type \u201cB\u201d – 60 days.<\/span><\/p>\n <\/p>\n Steps of the registration procedure:<\/b><\/p>\n <\/p>\n Registration certificate, language and labeling<\/b><\/p>\n The registration certificate is to be issued along with the approved text of the instruction for use (leaflet).<\/span><\/p>\n Labeling shall be approved in Mongolian, Russian and\/or English, and must comply with the requirements of the Law of Mongolia \u201cOn medicinal products and medical devices.\u201d<\/span><\/p>\n Instruction for use shall be performed in Mongolian.<\/span><\/p>\n The registration certificate under standard registration procedure is valid for 5 years.<\/span><\/p>\n The registration certificate under fast-track procedure is valid for 3 years.\u00a0<\/span><\/p>\n <\/p>\n Variations \/ changes\u00a0<\/b><\/p>\n During the validity of the registration certificate manufacturer must register the variations before the medicinal product is placed on the market.<\/span><\/p>\n Introduction of variation (registration of changes) shall be carried out on the basis of the official request of the manufacturer, submitted Application, rationale for the variation being introduced and registration materials, color printed copies of labeling of primary and secondary packaging, and samples, if necessary.<\/span><\/p>\n Depending on the nature of the variation, the examination procedure is carried out and approved at a meeting of the Expert Council on medicinal products, biological products and diagnostic kits.<\/span><\/p>\n <\/p>\n Renewal<\/b><\/p>\n Renewal (prolongation of the registration) is carried out on the basis of the submitted Application and the following package of documents:<\/span><\/p>\n Submission of the Application for renewal shall be performed until the expiration date of the Registration certificate.<\/span><\/p>\n <\/p>\n Cratia provides professional services of state registration (renewals, variations) of medicinal products in Mongolia. 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":140,"menu_order":1,"template":"","class_list":["post-538","countries","type-countries","status-publish","hentry"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/countries\/538","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\/140"}],"wp:attachment":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/media?parent=538"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n
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