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Decree of the Government of the Republic of Armenia N 2143-N of December 23, 2021 on making changes and additions in Decree of the Government of the Republic of Armenia N162-N of February 28, 2019
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Decree of the Government of the Republic of Armenia N 1302-N of August 06, 2020 on making additions in Decree of the Government of the Republic of Armenia N202-N of February 28, 2019
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Decree of the Government of the Republic of Armenia N 199-N of February 28, 2019 «Օn 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»
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Decree of the Government of the Republic of Armenia N 156-N of February 28, 2019 «Օn 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»
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Decree of the Government of the Republic of Armenia N 164-N of February 28, 2019 «Օn adopting the procedures in the Republic of Armenia related to rapid alert, termination of circulation and recall of nonregistered, non-conforming quality requirements, expired, registration withdrawal or suspended medicinal products, counterfeit medicinal products, active substance, herbal substances, investigational medicinal products and medicinal products imported in violation of the legislation of the Republic of Armenia»
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Decree of the Government of the Republic of Armenia N 168-N of February 28, 2019 «Օn adopting the rules of issuance a permission of clinical trials in the Republic of Armenia, assessment for this purpose, the lists of necessary documents and on repeal of the Decree of the Government of the Republic of Armenia N 63 of January 24, 2002»
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Decree of the Government of the Republic of Armenia N 1197-N of September 12, 2019 on making additions and changes in Decree of the Government of the Republic of Armenia N202-N of February 28, 2019
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Decree of the Government of the Republic of Armenia N 202-N of February 28, 2019 «Օn adopting the rule on importation in the Republic of Armenia and exportation from the Republic of Armenia of medicinal products, active substance, herbal substance and investigational medicinal products , the rule on assessment for the propose of importation and exportation and the list of necessary documents as well as on repeal of the Decree of the Government of the Republic of Armenia N 581 of September 20, 2000»
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Decree of the Government of the Republic of Armenia N 166-N of February 28, 2019 «On adopting the fees in the Republic of Armenia for assessments in the field of medicinal products state regulation» (Updated 08.06.2022)
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Decree of the Government of the Republic of Armenia N162-N of 28 February 2019 «On adopting the rules for state registration, re-registration, extension of the term of the certificate of medicinal product, as well as for refusal of registration, re-registration and of extension of the term of the certificate, for suspension of registration, withdrawal thereof, the rules for carrying out assessments for these purposes, as well as the rule for the submission and assessment of post-registration changes, the list of required documents, the list of changes of registered medicinal product which do not require new registration, the rule for inspection and for recognition of inspection reports of competent authorities of other countries, in the Republic of Armenia, and on repealing the decree of the Government of the Republic of Armenia N347 of 25 April 2001»
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