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Medicines registration by EAEU rulles

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
Decision EAEU N76 of November 03, 2016 on the Adoption of the Requirements for the Labelling of Medicinal Products for Human Use and Veterinary Medicinal Products
Decision EAEU N151 of September 07, 2018 on approval of the Guidelines for preparation of the normative document on the medicinal product quality
Decision of EAEU N113 of July 17, 2018 on approval of the Guidelines for validation of the analytical procedures for medicinal products testing
Decision of EAEU N9 of January 30, 2020 on the making changes of the rules of medicines registration and assessments
Common Technical Document (CTD) by EAEU rulles
Medicines registration application form by EAEU rulles (updated 07.10.2022)
Decision of EAEU N78 of November 03, 2016 on the rules of medicines registration and assessments and Decision of EAEU N55 of June 14, 2016 on the making changes of the Decision of EAEU N78 of November 03, 2016
  • Register
  • Guide to using "Database of registered medicines"
  • Drugs safety profile
  • ONLINE report about adverse effect of medicine

MEDICINES REGISTRATION

  • Requirements for the Power of Attorney
  • Registration Application
  • Registered medicines
  • Medicines recommended for registration by the Pharmacological Council of MOH of Republic of Armenia
  • Medicines not recommended for registration by the Pharmacological Council of MOH of Republic of Armenia
  • Order on medicines state registration by Minister of Health (MoH) of the Republic of Armenia (RA)
  • Register of medicines
  • Non prescription medicines registered in Republic of Armenia
  • List of registred prescription medicines in Republic of Armenia
  • List of registred under controled medicines in Republic of Armenia
  • List of registred medicines produced in Republic of Armenia
  • Rejection for registration
  • Withdrawal
  • Registration statistics
  • List of medicines liable to registration within the framework of the Government Orders
  • Announcements on medicines' registration
  • Legal documents on Registration
  • Presentation and format of the registration dossier Common Technical Document (CTD)
  • Re-registration dossie presentation and format
  • Variation dossier
  • Variation Guideline
  • Frequently Asked Questions (FAQ)
  • Medicines State Tax

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