{"id":138,"date":"2019-10-09T17:10:44","date_gmt":"2019-10-09T14:10:44","guid":{"rendered":"http:\/\/cratia.com\/?post_type=countries&#038;p=138"},"modified":"2023-04-27T14:02:27","modified_gmt":"2023-04-27T11:02:27","slug":"armeniya","status":"publish","type":"countries","link":"https:\/\/cratia.com\/en\/countries\/armeniya\/","title":{"rendered":"Armenia"},"content":{"rendered":"<p><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">The population of Armenia is about 3 million people. Since 2015, the country has been a member of the Eurasian Economic Union (EAEU), along with Belarus, Kazakhstan, Kyrgyzstan and Russia. Membership in the Union means that the Armenian legislation is constantly changing to harmonize with the legislative acts of the EAEU.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">The state language is Armenian. Although Russian is not in official use, it is widespread, it is spoken by about 70% of the country&#8217;s population, and is a compulsory subject in schools.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Import, sale and use of <\/span><b>medicinal products<\/b><span style=\"font-weight: 400;\"> in Armenia is allowed only after their state registration. Registration is carried out according to the national procedure, which provides for simplified registration, as well as to the EAEU Unified Rules. Any company, resident or non-resident of Armenia can act as a Marketing Authorization Holder (MAH) for registration; it is not required to set up a representative office or local company. The MAH must establish and maintain a pharmacovigilance system in Armenia, appoint a local contact person responsible for pharmacovigilance.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Import and sale of <\/span><b>medical equipment<\/b><span style=\"font-weight: 400;\"> and <\/span><b>medical devices<\/b><span style=\"font-weight: 400;\"> are allowed without state registration. However, in view of the entrance into the EAEU, it is planned to update and harmonize local legislation.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Import and sale of <\/span><b>special food products<\/b><span style=\"font-weight: 400;\"> are allowed only after their registration according to the \u201cunified\u201d procedure in one of the EAEU member countries.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Import and sale of <\/span><b>cosmetics<\/b><span style=\"font-weight: 400;\"> are permitted without state registration. However, in connection with the entrance into the EAEU, it is planned to update and harmonize local legislation. Currently, a Certificate of State Registration of Products\/Products Declaration obtained according to the &#8220;centralized&#8221; procedure in one of the EAEU member states, is recognized.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\"><b>Competent authorities:<\/b><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Ministry of Health of the Republic of Armenia<br \/>\n<\/span><span style=\"font-weight: 400;\">The central executive authority that implements public healthcare policy<br \/>\n<\/span><span style=\"font-weight: 400;\">Web site: <a href=\"http:\/\/www.moh.am\/\" target=\"_blank\" rel=\"noopener noreferrer\">http:\/\/www.moh.am\/<\/a><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Scientific Center for Drug and Medical Technology Expertise after Academician Emil Gabrielyan at the Ministry of Health of the Republic of Armenia<br \/>\n<\/span><span style=\"font-weight: 400;\">The competent authority responsible for expert work to register medicinal products and medical devices, as well as responsible for pharmacovigilance<br \/>\n<\/span><span style=\"font-weight: 400;\">Web site: <a href=\"http:\/\/www.pharm.am\" target=\"_blank\" rel=\"noopener noreferrer\">http:\/\/www.pharm.am<\/a>\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\"><b>The main legislative acts:<\/b><\/p>\n<ol style=\"text-align: justify;\">\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">The Law of the Republic of Armenia &#8220;On Medicines&#8221;;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Decree of the Government of the Republic of Armenia No. 162-N dated February 28, 2019 \u201cOn adopting the rules for state registration, re-registration, extension of the term of the certificate of medicinal product in the Republic of Armenia\u201d;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Decree of the Government of the Republic of Armenia No. 166-N dated February 28, 2019 \u201cOn adopting the fees in the Republic of Armenia for assessments in the field of medicinal products state regulation\u201d;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Decree of the Government of the Republic of Armenia No. 156-N dated February 28, 2019 \u201c\u0555n adopting the rules of inspection in the scope of distributor certification and issuance a Good Distribution Practice certificate, the assessment rule for the purpose of licensing the medicinal products wholesale realization and the list of necessary documents in the Republic of Armenia\u201d;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Decree of the Government of the Republic of Armenia No. 199-N dated February 28, 2019 \u201c\u0555n adopting the rules of compliance inspection with the requirements of Good Manufacturing Practice of medicinal products and pharmaceutical substance, the issuance of the Good Manufacturing Practice Certificate, as well as the assessment rule for the purpose of licensing the manufacturing of medicinal products and the list of necessary documents; and on repeal of the Decree of the Government of the Republic of Armenia N 1603-N of November 25, 2010 and the Decree of the Government of the Republic of Armenia N 1089-N of September 23, 2013\u201d;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Decree of the Government of the Republic of Armenia No. 150-N dated February 28, 2019 \u201cOn designation a body responsible for the organization and conduction the assessment and inspection in the field of state regulation of medicinal products circulation\u201d;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Order of the Ministry of Health No. 23-N of May 17, 2017 \u201cThe order of recording and reporting cases of adverse reactions, lack of effectiveness, misuse and suspect on falsification of medicines; collecting, reporting, monitoring, submitting reports and analyzing data on adverse reactions of medicines, approving the form of the register of adverse reaction and form of reporting of adverse reactions, lack of effectiveness, misuse and suspect on falsification of medicines\u201d.<\/span><\/li>\n<\/ol>\n<p style=\"text-align: justify;\"><span style=\"font-weight: 400;\">Cratia provides professional services on state registration of healthcare products in Armenia. We have a deep knowledge of the national legislation, significant experience, and necessary resources. We offer:<\/span><\/p>\n<ul style=\"text-align: justify;\">\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\"><a href=\"\/en\/countries\/armeniya\/registracziya-lekarstvennyh-sredstv\/\">registration of medicines in Armenia<\/a>;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">c<a href=\"\/en\/countries\/armeniya\/farmakonadzor\/\">reation and maintenance of a pharmacovigilance system in Armenia<\/a>;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\"><a href=\"\/en\/countries\/armeniya\/registracziya-mediczinskih-izdelij\/\">certification of medical devices in Armenia<\/a>;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\"><a href=\"\/en\/countries\/armeniya\/registracziya-dieticheskih-dobavok\/\">certification of special food products in Armenia<\/a>;<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\"><a href=\"\/en\/countries\/armeniya\/registracziya-kosmeticheskih-sredstv\/\">certification of cosmetics in Armenia<\/a>.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">To start cooperation or get advice, please contact us by phone: +38 068 064-78-31, +38 044 223-61-67, by e-mail: <a href=\"mailto:info@cratia.ua\">info@cratia.ua<\/a>, or visit <a href=\"\/en\/contacts\/\">our office<\/a>.\u00a0<\/span><\/p>","protected":false},"featured_media":137,"parent":0,"menu_order":0,"template":"","class_list":["post-138","countries","type-countries","status-publish","has-post-thumbnail","hentry"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/countries\/138","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\/137"}],"wp:attachment":[{"href":"https:\/\/cratia.com\/en\/wp-json\/wp\/v2\/media?parent=138"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}