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Decision EAEU N88 of November 03, 2016 on the Adoption of the Requirements for the Medication Guide and Summary of Product Characteristics of medicinal products for human use
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Decision of EAEU N78 of November 03, 2016 on the rules of medicines registration and assessments
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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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Information about making changes and additions in Decree of the Government of the Republic of Armenia N162-N of February 28, 2019
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Information regarding Order N312-N on approval of the rules of the Good Pharmacovigilance Practice in Republic of Armenia
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Information about temporary rule of acceptance of applications for state registration of medicines by national procedure
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Notification of a technical problem to INFO@ampra.am
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PLAN of inspections in compliance with the guideline of Good Manufacturing Practice of Eurasian Economic Union rules
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Information about new assesments fees procedure
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Information about changes in the activities of “Center of Drug and Medical Technology Expertise” SNPO
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