ABOUT US

• Board of Directors
• Laboratory of Medicines Quality Control
• General and External Affairs Department
• Medicines Registration Department
• Medicines Import and Export Control Department
• Good Pharmaceutical Practice Department
• Department on Rational Use of Medicines and Information
• Pharmacovigilance Department
• Controlled Substances Management Department
• Finance and Accounting Department
• Human Resources
• Coordinator procurerment

MAIN FUNCTIONS

• Legislation
  • Laws
    • Tax code of the Republic of Armenia
    • Republic of Armenia Law "On Medicines"
    • Republic of Armenia Law "On licensing"
    • Republic of Armenia Law "On narcotics and psychotropic substances"
    • Republic of Armenia Law "On medical aid and population services"
    • Republic of Armenia Law "On advertising"
    • Republic of Armenia Law "On state duty"
    • The labour code of the Republic of Armenia
    • Republic of Armenia Law "On Procurement"
  • Decrees
    • Decree of the Government of the Republic of Armenia N 715-N of May 16, 2022 on making changes in Decree of the Government of the Republic of Armenia N166-N of February 28, 2019
    • 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
    • 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
    • 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»
    • 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»
    • 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»
    • 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»
    • 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
    • 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»
    • 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)
    • 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»
    • Decree of the Government of the Republic of Armenia N 150-N February 28, 2019, «On designation a body responsible for organization and conduction the assessment and inspection in the field of state regulation of medicinal products circulation»
    • Decree оf the Minister of Health оf the Republic of Armenia N 1178-N of September 28, 2017, on approving «Essential medicines choice criteria in the Republic of Armenia»
    • Decree of the Government of the Republic of Armenia N 172-A of February 23, 2017 «Օn determination of the international organization as defined by the Law "On Medicines" of the Republic of Armenia
    • Decree of the Government of the Republic of Armenia N716-N of June 23, 2017 on approval of the list of the acting Pharmacopoeias in the Republic of Armenia
    • Decree of the Government of the Republic of Armenia N 867 of June 29, 2002
    • Decree of the Government of the Republic of Armenia N 281-N of March 18, 2011
    • Decree of the Government of the Republic of Armenia N 1129-N of August 21, 2003
    • Decree of the Government of the Republic of Armenia N 1608-N of November 2, 2006, «On adopting the order of granting permission to advertise medicines, medical equipment and methods of treatment and requirements made to these advertisements»
    • Decree of the Government of the Republic of Armenia N 1717-N of November 23 2006, «On adopting the list of diseases and social groups of population entitled to free or privileged purchase of medicines»
    • Decree of the Government of the Republic of Armenia N 270-N of March 18, 2010, «On establishing the rules of circulation of Narcotics and Psychotropic substances and their precursors»
    • Decree of the Government of the Republic of Armenia N1217-N of 11 August, 2005, “On the foundation of a state licensed body on monitoring the import of foods (honey) having organic origin”
    • Decree of the Government of the Republic of Armenia N 759 of August 14, 2001
    • Decree of the Government of the Republic of Armenia N734-N of 28 May, 2011 on approving implementation schedule of the rules of Good Manufacturing Practices (GMP) and realization of reforms in medicines circulation in the Republic of Armenia
    • Decree of the Government of the Republic of Armenia N 724-N of July 4, 2013, «On adopting the check lists of risk based inspection on assuring mandatory requirements of importers, exporters and entities carrying out pharmaceutical activity»
    • Decree of the Government of the Republic of Armenia N 1196-N of September 25, 2008, «On adopting the maximum residual quantities of veterinary medicines in the food of animal origin»
    • Decree of the RA N 386-N of 6 April 2017 «On approving the procedure for carring out E-procurement and repealing decree No 1370-N of 5 december 2013 of the Goverment of the RA»
    • Decree of the RA N 526-N of 4 May 2017 «On approving the procedure for organisation of the procurement process and repealing decree of the Government of the RA No 168-N Of 10 february 2011»
    • Decree of the Government of thy RA N 759-N of 29 June 2017 «On approving the procedure for conferring qualification on procurement co-ordinators and continuous professional training thereof and repealing decree of the Government of the RA No 99-N of 12 february 2015»
  • Orders
    • Order of Minister of Health of the Republic of Armenia N 4639-A of October 04, 2022 «On establishing a temporary procedure for submitting applications for state registration of medicinal products for human use in the Republic of Armenia»
    • Order on approval of the price list of paid services provided by the Scientific Center of Drug and Medical Technologies Expertise N 029-A-22 of February 14, 2022
    • Order of Minister of Health of the Republic of Armenia N 2095-A of June 02, 2021 «On establishing of the Medicines Provision Council at the Minister of Health of the Republic of Armenia, on approving the charter and the staff of the Medicines Provision Council and on repealing the order of Minister of Health of the Republic of Armenia N 3482-A of 5 December 2017»
    • Joint Order of Minister of Health of the Republic of Armenia N52-N of September 20, 2013 and Chairman of the State Revenue Committee of the Government of the Republic of Armenia N416-N of September 24, 2013 on “Approval of the certificate forms of the import and export of the narcotics, psychotropic substances and their precursors”
    • Order of Minister of Health of the Republic of Armenia N335-A of February 05, 2021 "On defining of new validity data of Good Manufacturing Practice certificates for manufactures in the Republic of Armenia"
    • Order of Minister of Health of the Republic of Armenia N01-N of January 16, 2020 «On approval of the requirements for the responsible person of wholesale distributor for good distribution practice»
    • Order of Minister of Health of the Republic of Armenia N02-N of January 21, 2020 «On approval of the requirements of labeling and packaging for medicinal products, pharmaceutical substances, herbal raw materials, investigational medicinal products, as well as for the patient leaflet, summary of product characteristics and trade names of medicinal products, and on excipients that must be indicated on the secondary packaging in Republic of Armenia»
    • Order of the Minister of Health of the Republic of Armenia N39-N of September 27, 2019 on making changes and additions in Order of the Minister of Health of the Republic of Armenia N 07-N of April 13, 2018
    • Order of the Minister of Health of the Republic of Armenia N33-N of June 28, 2019 on repealing order of the Minister of Health of the Republic of Armenia N 662 of October 10, 2002, order of the Minister of Health of the Republic of Armenia N 05-N of 17 May, order of the Minister of Health of the Republic of Armenia N 21-N of November 15, 2011, order of the Minister of Health of the Republic of Armenia N 18-N of May 20, 2013
    • Order of Minister of Health of the Republic of Armenia N31–N of 10 June 2019 on adopting the form of state registration certificate of medicinal products, the structure of register and operational rule of it, the rule for determining the classification of the medicinal product to the class of prescription and non-prescription medicinal products and its revision in the Republic of Armenia and on repealing the order of Minister of Health of the Republic of Armenia N123 of 7 February 2006
    • Order of the Ministry of Health of Republic of Armenia N1048-A of 02 May, 2019 on repeal of order of the Ministry of Health of Republic of Armenia N303-A of 24 February, 2012
    • Order of the Ministry of Health of Republic of Armenia N1047-A of 02 May, 2019 on repeal of order of the Ministry of Health of Republic of Armenia N2006-A of 10 October, 2011
    • Order of the Ministry of Health of Republic of Armenia N3202-A of 12 December, 2018 on establishment the ethics committee for clinical trials authorization and approval the list of commission members
    • Order of the Ministry of Health of Republic of Armenia N3399-A, of November 30, 2017 on using decision N173, N174 of December 22, 2015 and N177 of December 29, 2015 of the Board of the Eurasian Economic Commission
    • Order of the Ministry of Health of Republic of Armenia N3398-A, of November 30, 2017 on using decision N29, N42 of February 12, 2016 and N38 of May 12, 2016 of the Council of the Eurasian Economic Commission
    • Order of the Ministry of Health of Republic of Armenia N3339-A, of November 22, 2017 on using decision N46 of February 12, 2016 of the Council of the Eurasian Economic Commission
    • Order of the Ministry of Health of the Republic of Armenia N27-N of May 18, 2017 «On adopting the rules on Good Laboratory Practice»
    • Order of the Ministry of Health of the Republic of Armenia N24-N of May 17, 2017 «On adopting the rules on Good Distribution Practice»
    • Order of the Ministry of Health of the Republic of Armenia N25-N of May 17, 2017 «On adopting the rules on Good Clinical Practice»
    • Order of the Ministry of Health of the Republic of Armenia N28-N of June 7, 2017 «On adopting the requirements for qualified person of the medicinal product manufacturer»
    • Order of the Ministry of Health of the Republic of Armenia N23-N of May 17 2017 on approving “The 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
    • Order of the Ministry of Health of the Republic of Armenia N20-N of May 15, 2015 on approving "Drugs unknown adverse reactions report form"
    • Order of the Minister of Health of the Republic of Armenia N 22-N of November 20, 2008, on adopting the list of low demand but vital medicines amended by the Order of the Minister of Health of the Republic of Armenia N 02-N of January 19, 2015
    • Order of the Minister of Health of the Republic of Armenia N56-N of July 28, 2021 on approving the "Essential Medicines List" and on repealing the order of Minister of Health of the Republic of Armenia N07-N of March 17, 2018
    • Order of the Minister of Health of the Republic of Armenia N 74-N of January 27, 2005, «On adopting the order of free or privileged provision of medicines»
    • Order of the Minister of Health of the Republic of Armenia N 100 of February 26, 2002
    • Order of the Highest Attestation Committee of Republic of Armenia N 149 of November 12, 1997
    • Order of the Highest Attestation Committee of the Republic of Armenia N 82 of June 27, 2000
    • Order of the Highest Attestation Committee of Order of the Republic of Armenia N 83 of June 27, 2000, «On the order of adopting dissertation topics»
    • Order of the Minister of Health of the Republic of Armenia N 22-N of November 20, 2008, on adopting the list of low demand but vital medicines
    • Order of the Minister of Health of the Republic of Armenia N 03-A of March 4, 2008 on adopting sanitary rules and norms N 2.1.3-3 «Hygienic and antiepidemic demands to the usage of medical wastes in RA»
    • Order of the Minister of Health of the Republic of Armenia N 17-N of September 9, 2010
    • Order of the Minister of Health of the Republic of Armenia N1325-A of July 8, 2011, «On adopting the list of necessary legal acts and program of implementation of the Quality management system required for the activity of the GMP/GDP inspection department
    • Order of the Minister of Health of the Republic of Armenia N 05-N of February 1, 2013, «On adopting the rules of medical waste management in pharmacies and pharmaceutical outlets»
    • Order of the Minister of Health of the Republic of Armenia N 189-A of February 06, 2014, «On adopting the GMP compliance inspection fee»
    • Order of the Minister of Health of the Republic of Armenia 1324-A, July 8, 2011
    • Order of the Minister of Health of the Republic of Armenia 1395-A, June 15, 2012
    • Order of the Minister of Health of the Republic of Armenia 1396-A, June 15, 2012
    • Order of the Minister of Health of the Republic of Armenia 1613-A, July 8, 2014
  • Conventions
    • Single Convention on Narcotic Drugs, 1961, as amended by the Protocol amending the Single Convention on Narcotic Drugs, 1972
    • Convention on collaboration in the struggling against the counterfeit medicinal products circulation
    • Convention on Psychotropic Substances, 1971
    • United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988
    • According to decree of the President of the Republic of Armenia from December 2, 2009 N DP-297-N
  • Other documents
    • Pharmacovigilance Guideline
    • List of essential medicines of RA (updated 23.11.2021)
    • Common Technical Documents of Medicinal Products Registration
• Assessments fees
  • Pro-forma invoices of paid services according to the order N 029-A-22 of 14.02.2022
  • Pro-forma invoice for the registration, re-registration, renewal, variation assessment fees (Updated 03.11.2021)
  • 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)
  • Bank Requisites (Updated 21.01.2022)
• Medicines Registration
  • Requirements for the Power of Attorney
    • Requirements for the Power of Attorney (Updated 11.11.2021)
  • Medicines State Tax
    • Medicines State Tax (24.05.2019)
  • Registration, Re-Registration and Variation Applications
    • Registration and Re-registration Application (Updated 11.11.2022)
    • Variation application (Updated 11.11.2022)
  • Presentation and format of the registration dossier Common Technical Document (CTD)
    • Presentation and format of the registration dossier Common Technical Document (CTD) (Updated 13.06.2019)
  • Re-registration dossier presentation and format
    • Re-registration dossier presentation and format (Updated 15.05.2019)
  • Variation Guideline
    • Variation Guideline (10.10.2022)
  • Variation dossier
    • Variation dossier (Updated 16.05.2019)
  • The List of Medicines recommended for registration
    • The list of medicines recommended for registration (15.03.2023)
    • The list of medicines recommended for registration (28.02.2023)
    • The list of medicines recommended for registration (31.01.2023)
    • The list of medicines recommended for registration (29.12.2022)
    • The list of medicines recommended for registration (15.12.2022)
    • The list of medicines recommended for registration (30.11.2022)
    • The list of medicines recommended for registration (14.11.2022)
    • The list of medicines recommended for registration (28.10.2022) Updated 03.11.2022
    • The list of medicines recommended for registration (30.09.2022) Updated 17.10.2022
    • The list of medicines recommended for registration (15.09.2022)
    • The list of medicines recommended for registration (30.08.2022)
    • The list of medicines recommended for registration (15.08.2022)
    • The list of medicines recommended for registration (28.07.2022)
    • The list of medicines recommended for registration (14.07.2022)
    • The list of medicines recommended for registration (29.06.2022)
    • The list of medicines recommended for registration (15.06.2022)
    • The list of medicines recommended for registration (30.05.2022)
    • The list of medicines recommended for registration (13.05.2022)
    • The list of medicines recommended for registration (29.04.2022)
    • The list of medicines recommended for registration (21.04.2022)
    • The list of medicines recommended for registration (06.04.2022)
    • The list of medicines recommended for registration (30.03.2022)
    • The list of medicines recommended for registration (11.03.2022)
    • The list of medicines recommended for registration (25.02.2022) (updated 31.03.2022)
    • The list of medicines recommended for registration (11.02.2022) (updated 03.03.2022)
    • The list of medicines recommended for registration (27.01.2022)
    • The list of medicines recommended for registration (14.01.2022)
    • The list of medicines recommended for registration (28.12.2021)
    • The list of medicines recommended for registration (10.12.2021)
  • The List of Medicines not recommended for registration
    • The list of medicines not recommended for registration (28.02.2023)
    • The list of medicines not recommended for registration (29.12.2022)
    • The list of medicines not recommended for registration (15.12.2022)
    • The list of medicines not recommended for registration (30.11.2022)
    • The list of medicines not recommended for registration (28.10.2022)
    • The list of medicines not recommended for registration (15.09.2022)
    • The list of medicines not recommended for registration (30.08.2022)
    • The list of medicines not recommended for registration (15.08.2022)
    • The list of medicines not recommended for registration (28.07.2022)
    • The list of medicines not recommended for registration (29.06.2022)
    • The list of medicines not recommended for registration (13.05.2022)
    • The list of medicines not recommended for registration (29.04.2022)
    • The list of medicines not recommended for registration (21.04.2022)
    • The list of medicines not recommended for registration (30.03.2022)
    • The list of medicines not recommended for registration (11.03.2022)
    • The list of medicines not recommended for registration (11.02.2022) (updated 03.03.2022)
    • The list of medicines not recommended for registration (27.01.2022)
    • The list of medicines not recommended for registration (28.12.2021)
    • The list of medicines not recommended for registration (10.12.2021)
  • Order on medicines state registration by Minister of Health (MoH) of the Republic of Armenia (RA)
    • N 1497-A (23.03.2023) Order by MoH of RA
    • N 1496-A (23.03.2023) Order by MoH of RA
    • N 1495-A (23.03.2023) Order by MoH of RA
    • N 1430-A (22.03.2023) Order by MoH of RA
    • N 1423-A (22.03.2023) Order by MoH of RA
    • N 1396-A (20.03.2023) Order by MoH of RA
    • N 1395-A (20.03.2023) Order by MoH of RA
    • N 1394-A (20.03.2023) Order by MoH of RA
    • N 1393-A (20.03.2023) Order by MoH of RA
    • N 1204-A (10.03.2023) Order by MoH of RA
    • N 1169-A (09.03.2023) Order by MoH of RA
    • N 1168-A (09.03.2023) Order by MoH of RA
    • N 1099-A (06.03.2023) Order by MoH of RA
    • N 1098-A (06.03.2023) Order by MoH of RA
    • N 1097-A (06.03.2023) Order by MoH of RA
    • N 1051-A (03.03.2023) Order by MoH of RA
    • N 1049-A (03.03.2023) Order by MoH of RA
    • N 1048-A (03.03.2023) Order by MoH of RA
    • N 1047-A (03.03.2023) Order by MoH of RA
    • N 1046-A (03.03.2023) Order by MoH of RA
    • N 773-A (17.02.2023) Order by MoH of RA
    • N 553-A (06.02.2023) Order by MoH of RA
    • N 552-A (06.02.2023) Order by MoH of RA
    • N 551-A (06.02.2023) Order by MoH of RA
    • N 550-A (06.02.2023) Order by MoH of RA
    • N 549-A (06.02.2023) Order by MoH of RA
    • N 548-A (06.02.2023) Order by MoH of RA
    • N 547-A (06.02.2023) Order by MoH of RA
    • N 320-A (26.01.2023) Order by MoH of RA
    • N 318-A (26.01.2023) Order by MoH of RA
    • N 302-A (25.01.2023) Order by MoH of RA
    • N 301-A (25.01.2023) Order by MoH of RA
    • N 202-A (18.01.2023) Order by MoH of RA
    • N 65-A (10.01.2023) Order by MoH of RA
    • N 64-A (10.01.2023) Order by MoH of RA
    • N 63-A (10.01.2023) Order by MoH of RA
    • N 62-A (10.01.2023) Order by MoH of RA
    • N 61-A (10.01.2023) Order by MoH of RA
    • N 60-A (10.01.2023) Order by MoH of RA
    • N 59-A (10.01.2023) Order by MoH of RA
    • N 58-A (10.01.2023) Order by MoH of RA
    • N 57-A (10.01.2023) Order by MoH of RA
    • N 56-A (10.01.2023) Order by MoH of RA
    • N 6075-A (28.12.2022) Order by MoH of RA
    • N 5992-A (26.12.2022) Order by MoH of RA
    • N 5991-A (26.12.2022) Order by MoH of RA
    • N 5967-A (23.12.2022) Order by MoH of RA
    • N 5966-A (23.12.2022) Order by MoH of RA
    • N 5965-A (23.12.2022) Order by MoH of RA
    • N 5964-A (23.12.2022) Order by MoH of RA
    • N 5963-A (23.12.2022) Order by MoH of RA
    • N 5962-A (23.12.2022) Order by MoH of RA
    • N 5961-A (23.12.2022) Order by MoH of RA
    • N 5692-A (09.12.2022) Order by MoH of RA
    • N 5678-A (08.12.2022) Order by MoH of RA
    • N 5675-A (08.12.2022) Order by MoH of RA
    • N 5646-A (07.12.2022) Order by MoH of RA
    • N 5644-A (07.12.2022) Order by MoH of RA
    • N 5643-A (07.12.2022) Order by MoH of RA
    • N 5642-A (07.12.2022) Order by MoH of RA
    • N 5631-A (06.12.2022) Order by MoH of RA
  • Register of medicines
    • Register of medicines
  • Non prescription medicines registered in Republic of Armenia
    • Non prescription medicines registered in RA (Up to 28.02.2023)
  • The list of registred prescription medicines in Republic of Armenia
    • The list of registred prescription drugs in Republic of Armenia (Up to 28.02.2023)
  • The list of registred under controled medicines in Republic of Armenia
    • The list of registred under controled drugs in Republic of Armenia (Up to 31.12.2022)
  • The list of registred medicines produced in Republic of Armenia
    • The list of registred medicines produced in Republic of Armenia (up to 28.02.2023)
  • Rejection for registration
    • Rejection for Registration (2022)
    • Rejection for Registration (2021)
    • Rejection for Registration (2020)
    • Rejection for Registration (2019)
    • Rejection for Registration (2018)
    • Rejection for Registration (2017)
    • Rejection for Registration (2016)
  • Revoked and suspended medicines
    • List of registration revoked and suspended medicines (2022)
    • List of registration revoked and suspended medicines (2021)
    • List of registration revoked and suspended medicines (2020)
    • Withdrawal (2019)
    • Withdrawal (2018)
    • Withdrawal (2017)
    • Withdrawal (2016)
  • The list of medicines liable to registration within the framework of the Government Orders
    • The list of medicines liable to registration within the framework of the Government Orders
  • Announcements on medicines' registration
    • Update of Requirements to the State Registration of Medicines in the Republic of Armenia
    • Data request of original medicine
    • Refuse/suspension/ revoke of medicinal product registration
    • Information on reasons of registration suspension of medicinal products (0101176816/27.04.2016)
    • Information on appropriate receipt of SmPC, PIL and packaging e-versions (0101176616/27.04.2016)
    • Information on registration dossier of medicinal product (0101176716/27.04.2016)
    • Information on the implementation of the document circulation at the Scientific Center (0101037816/12.03.16) Updated 11.03.2020
    • Information concerning the lists of medicines recommended/not recommended to registration by the Pharmacological Council (0101035016/09.03.16)
    • Information on the State tax transfer for the companies that do not have authorized representative in the RA (0201014409/18.03.09 and 0101034916/09.03.16)
    • Information concerning the order for submission of registration dossiers, samples and standards to the Scientific Centre (handling/acceptance acts) (0101236415/29.12.15)
    • Information concerning availability of electronic versions of medicines mock-ups, leaflet inserts and summary of product characteristics (0401126314/30.10.14 and 0101013115/06.02.15)
    • Information on the creation of an electronic database of registration dossiers (0101029012/24.03.12)
  • Frequently Asked Questions (FAQ)
    • Frequently Asked Questions (FAQ) (updated 21.02.2021)
  • Legal documents on Registration
    • Order of Minister of Health of the Republic of Armenia N31–N of 10 June 2019 on adopting the form of state registration certificate of medicinal products, the structure of register and operational rule of it, the rule for determining the classification of the medicinal product to the class of prescription and non-prescription medicinal products and its revision in the Republic of Armenia and on repealing the order of Minister of Health of the Republic of Armenia N123 of 7 February 2006
    • Republic of Armenia Law “On drugs”
    • Republic of Armenia Law “On licensing”
    • Republic of Armenia Law “On narcotics and psychotropic substances”
    • Republic of Armenia Law “On medical aid and population services”
    • 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»
    • 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»
    • 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»
    • Decree of the Government of the Republic of Armenia N 867 of June 29, 2002
    • Decree of the Government of the Republic of Armenia N 1129-n of August 21, 2003, on ratifying “The list of narcotics, psychotropic substances and their precursors, subject to control in RA”
    • Decree of the Government of the Republic of Armenia N 281-N of March 18, 2011
    • Order of the Minister of Health of the Republic of Armenia N 07-N of April 13, 2018 on approving the "Essential Medicines List" and Order on making changes N14-N of May 31, 2018
    • Decree of the Government of the Republic of Armenia N 172-A of February 23, 2017 «Օn determination of the international organization as defined by the Law "On Medicines" of the Republic of Armenia
    • Decree of the Government of the Republic of Armenia N716-N of June 23, 2017 on approval of the list of the acting Pharmacopoeias in the Republic of Armenia
• 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
• Import and export of medicines
  • Pharmaceutical products rejected on their import
    • N 1397-A (29.05.2019) Order by MoH of RA on medicine withdrawal from registration and circulation
    • N 1396-A (29.05.2019) Order by MoH of RA on medicine withdrawal from registration and circulation
    • Order N764-А/29.03.2019 of the Ministry of Health of the Republic of Armenia on medicine withdrawal from circulation
    • Order N576-А/07.03.2019 of the Ministry of Health of the Republic of Armenia on medicine withdrawal from circulation
    • Order N205-А/30.01.2019 of the Ministry of Health of the Republic of Armenia on medicine withdrawal from circulation
    • Order N122-А/21.01.2019 of the Ministry of Health of the Republic of Armenia on medicine withdrawal from circulation
  • Importers
    • Armenian Importers’ list
  • Legal documents on Import and Export of pharmaceutical products
    • Republic of Armenia Law “On Medicines”
    • Republic of Armenia Law “On licensing”
    • Republic of Armenia Law “On medical aid and population services”
    • 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»
    • 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»
• Clinical trials
  • Permitted clinical trials
    • Permitted clinical trials (2021)
    • Permitted clinical trials (2020)
    • Permitted clinical trials (2019)
    • Permitted clinical trials (2018)
    • Permitted clinical trials (2017)
    • Permitted clinical trials (2016)
    • Permitted clinical trials (2015)
    • Permitted clinical trials (2011-2014)
    • Permitted clinical trials (2010)
    • Permitted clinical trials (2009)
    • Permitted clinical trials (2007-2008)
  • List of the documents required for the approval of conducting the clinical trials of drugs in the Republic of Armenia
    • The list of the documents required for the approval of conducting the clinical trials of drugs in the Republic of Armenia
  • Legal documents on clinical trials
    • 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»
    • Republic of Armenia Law “On medical aid and population services”
    • 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»
• GMP compliance
  • Good Manufacturing Practice compliance for medicinal products
    • Good Manufacturing Practice compliance for medicinal products
  • Contract for Conducting Good Manufacturing Practice Compliance Inspection
    • Contract Template for Conducting Good Manufacturing Practice Compliance Inspection
  • Appendix To the Contract for Conducting Good Manufacturing Practice Compliance Inspection
    • Appendix Template To the Contract for Conducting Good Manufacturing Practice Compliance Inspection
  • Standard template of the letter
    • Standard template of the letter
  • Legal basis for conducting inspections
  • The list of authorized manufacturers in the Republic of Armenia
    • Armenian Manufacturers list
  • The Good Manufacturing Practice assessment compliace during the marketing authorization
    • Note of guidance on submittion of data on manufacturers of medicinal products authorized in the RA
  • Legal acts regulating the Good Manufacturing Practice system in the Republic of Armenia
    • The list of Legal acts reletad to activities of Good Practice Inspection department in the Scientific Center of Drug and Medical Technology Expertise after academician Emil Gabrielyan
    • Order of Minister of Health of the Republic of Armenia N335-A of February 05, 2021 "On defining of new validity data of Good Manufacturing Practice certificates for manufactures in the Republic of Armenia"
  • International documents related to medicines manufacturing
  • The Good Manufacturing Practice certificates issued by the Ministry of Health of the Republic of Armenia
    • The certificates of Good Manufacturing Practice issued by the Ministry of Health of the Republic of Armenia
  • Frequently Asked Questions (FAQ)
• GDP compliance
  • Good Distribution Practice compliance for medicinal products in the Republic of Armenia
  • Licensing of wholesale distribution in the Republic of Armenia
  • Legal acts regulating the Good Distribution Practice system in the Republic of Armenia
    • The list of Legal acts reletad to activities of Good Practice Inspection department in the Scientific Center of Drug and Medical Technology Expertise after academician Emil Gabrielyan
  • International documents related to wholesale distribution
  • The list of authorized wholesalers in the Republic of Armenia
  • Recall of medicinal products from the market
  • Frequently Asked Questions (FAQ)
• Market surveillance
  • Counterfeit pharmateutical products
    • Counterfeit medicines found from 2017
    • About Counterfeit Pharmateutical Products
    • A counterfeit medicine has been detected by the Scientific Centre of Drug and Medical Technology Expertise (“Augmentin”)
    • A counterfeit dietary supplement has been detected by the Scientific Centre of Drug and Medical Technology Expertise (“Ali Caps”)
    • A counterfeit dietary supplement “Sealex Forte” has been detected by the Scientific Centre of Drug and Medical Technology Expertise
    • Counterfeit medicines and dietary supplements found from 2001-2012
  • Products with quality defects and recall
    • N 1397-A (29.05.2019) Order by MoH of RA on medicine withdrawal from registration and circulation
    • N 1396-A (29.05.2019) Order by MoH of RA on medicine withdrawal from registration and circulation
    • Order N764-А/29.03.2019 of the Ministry of Health of the Republic of Armenia on medicine withdrawal from circulation
    • Order N576-А/07.03.2019 of the Ministry of Health of the Republic of Armenia on medicine withdrawal from circulation
    • Order N205-А/30.01.2019 of the Ministry of Health of the Republic of Armenia on medicine withdrawal from circulation
    • Order N122-А/21.01.2019 of the Ministry of Health of the Republic of Armenia on medicine withdrawal from circulation
  • Domestic manufacturers
    • Armenian Manufacturers list
  • The list of narcotics, psychotropic substances and their precursors, subject to control in Republic of Armenia
    • The list of narcotics, psychotropic substances and their precursors, subject to control in Republic of Armenia
• Essential Medicines
• Drug safety monitoring
• The Procurements Process
  • Announcements
  • Applications
  • Evaluation Committee Conference Records
  • Contracts
  • Reports
• International cooperation
  • World Health Organization
  • WHO Europe
  • International Conference on Harmonization (ICH)
  • European Medicines Evaluation Agency (EMEA)
  • US Food and Drug Administration (FDA)
  • The Uppsala Monitoring Centre
  • PIC/S
  • EDQM
  • GMDN Agency
  • The Melclass Database (EDQM)
  • FDA Approved Drug Products
• OTHER
  • List of documents required for determining the regulatory status of borderline products

PUBLICATIONS

• "Drugs and Medicines" Information Bulletin
  • «Drugs and Medicine» Information Bulletin N3-2017
  • «Drugs and Medicine» Information Bulletin N2-2017
  • «Drugs and Medicine» Information Bulletin N1-2017
  • «Drugs and Medicine» Information Bulletin N4-2016
  • «Drugs and Medicine» Information Bulletin N3-2016
  • «Drugs and Medicine» Information Bulletin N2-2016
  • «Drugs and Medicine» Information Bulletin N1-2016
  • «Drugs and Medicine» Information Bulletin N4-2015
  • «Drugs and Medicine» Information Bulletin N3-2015
  • «Drugs and Medicine» Information Bulletin N2-2015
  • «Drugs and Medicine» Information Bulletin N1-2015
  • «Drugs and Medicine» Information Bulletin N4-2014
  • «Drugs and Medicine» Information Bulletin N3-2014
  • «Drugs and Medicine» Information Bulletin N2-2014
  • «Drugs and Medicine» Information Bulletin N1-2014
  • «Drugs and Medicine» Information Bulletin N4-2013
  • «Drugs and Medicine» Information Bulletin N3-2013
  • «Drugs and Medicine» Information Bulletin N2-2013
  • «Drugs and Medicine» Information Bulletin N1-2013
  • «Drugs and Medicine» Information Bulletin N4-2012
  • «Drugs and Medicine» Information Bulletin N3-2012
  • «Drugs and Medicine» Information Bulletin N2-2012
  • «Drugs and Medicine» Information Bulletin N1-2012
• “Safety of drugs” information leaflet
  • “Safety of drugs” information leaflet N1-2018
  • “Safety of drugs” information leaflet N3-2017
  • “Safety of drugs” information leaflet N2-2017
  • “Safety of drugs” information leaflet N1-2017
  • “Safety of drugs” information leaflet N3-2016
  • “Safety of drugs” information leaflet N2-2016
  • “Safety of drugs” information leaflet N1-2016
  • “Safety of drugs” information leaflet N1-2015
  • “Safety of drugs” information leaflet N2-2015
  • “Safety of drugs” information leaflet N1-2013
  • “Safety of drugs” information leaflet N4-2013
  • “Safety of drugs” information leaflet N3-2012
  • “Safety of drugs” information leaflet N2-2012
  • “Safety of drugs” information leaflet N1-2012
  • “Safety of drugs” information leaflet N4-2011
  • “Safety of drugs” information leaflet N3-2011
  • “Safety of drugs” information leaflet N2-2011
  • “Safety of drugs” information leaflet N1-2011
  • “Safety of drugs” information leaflet N4-2010
  • “Safety of drugs” information leaflet N3-2010
• Dear Healthcare Professional Letter
  • L-Thyroxin Berlin-Chemie (levothyroxine) new formulation tablets: monitoring of patients switching between tablets
  • Therapy guide with Vsiqq (brolucizumab)
  • Actemra (tocilizumab)
  • Tecentriq (atezolizumab)
  • Direct Healthcare Professional Communication about Recormon (epoetin beta)
  • Novartis information on ophthalmic products based on Safety Notice provided by Becton Dickinson Company
  • Supply situation for Actemra IV - outlook for 2022
  • Kadcyla: Educational Information For Healthcare Professional
  • Important information about MabThera
  • ALECENSA (alectinib), Warning and Precaution and Specific Dose Modification Guidance for Management of Haemolytic Anaemia
  • Champix (varenicline)
  • Brolucizumab (VSIQQ)
  • CellCept (mycophenolate mofetil): information about risks to the unborn baby
  • Jadenu film-coated tablets (deferasirox): new formulation, new posology, and new method of administration
  • Actemra® (tocilizumab) - Notification of Temporary Supply Shortage for solution for infusion (IV) & recommendations to manage potential risk of disease flare in patients
  • Metamizole: Risk of drug-induced liver injury
  • Myfortic (mycophenolic acid): risk of teratogenicity
  • Actemra
  • Tivicay (dolutegravir): updated information on neural tube defects reported in Tsepamo Study, Botswana
  • Tecentriq (atezolizumab), identified risk of severe cutaneous adverse reactions (SCARs) direct healthcare professional communication (DHPC)
  • Cellcept (mycophenolate mopetil)
  • Retinoids (Isotretinoin) - update on teratogenicity and neuropsychiatric disorders Direct Healthcare
  • Important information about Mabthera
  • Important information on Dacarbazine medac 200 mg: decreased stability after reconstitution
  • Leuprorelin-containing depot products: need to strictly follow instructions for reconstitution and administration to reduce the risk of handling errors that may result in lack of efficacy
  • 5-Fluorouracil (i.v.), capecitabine and tegafur containing products
  • The risk of birth defects from the recently published epidemiological studies for Zofran (Ondansetron)
  • New important information on safety of medicine Esmya, 5 mg tablets
  • Domperidone-containing products: reminder of indication and contraindications related to serious cardiac side efefcts
  • Methotrexate
  • Kadcyla: HCP Educational Information
  • Tecentriq (atezolizumab)
  • Actemra (tocilizumab)
  • Systemic and inhaled fluoroquinolones: risk of aortic aneurysm and dissection
  • ADENURIC (febuxostat): increased risk of cardiovascular death and all-cause mortality in patients treated with febuxostat in the CARES study
  • Lapatinib (Tyverb): important update to Summary of Product Characteristics
  • Actemra (tocilizumab): a new important identified risk: hepatotoxicity
  • Important information about MabThera
  • Actemra (tocilizumab)
  • Tecentriq (atezolizumab): a new important identified risk: immune-related myositis
  • Eurespal (fenspiride) withdrawal from the market in Armenia
  • Medicinal products containing carbimazole or thiamazole (methimazole): risk of acute pancreatitis and risks during pregnancy
  • Kadcyla: HCP Educational Information
  • Information about Flemoxin Solutab® (Amoxicillin trihydrate), Flemoclave Solutab® (Amoxicillin+clavulanic acid), Wilprafen Solutab® (Josamycin propionate), Suprax Solutab® (Cefixime), Unidox Solutab® (Doxycycline)
  • Actemra (tocilizumab)
  • Important safety update of prescribing information for xeloda® (capecitabine)
  • Information on Actemra
  • Eligard (leuprorelin acetate) - Medication errors associated with leakage due to overtightening of the safety needle
  • CELLCEPT (mycophenolate mofetil): risk of teratogenicity guide
  • Safety notice on medical device «Prismaflex»
  • Herceptin (trastuzumab). Importance of cardiac monitoring to reduce the frequency and severity of left ventricular dysfunction and congestive heart failure during trastuzumab therapy
  • Mirabegron (Betmiga) - new recommendations about the risk of increase in blood pressure
  • Important safety update of prescribing information for Xeloda® (capecitabine)
  • Bioparox (fusafungine) aerosol will no longer be available on the market
  • CellCept® (mycophenolate mofetil): teratogenic risk prevention
  • Bioparox (fusafungine) spray: new contra-indications and recommendations to minimize the risk of serious allergic reactions
• Booklets
  • Pharmacovigilance
  • Safety medicines
  • Antibiotics

COMMITTEES AND COUNCILS

• Pharmacological Council

NEWS AND ANNOUNCEMENTS

• News and Announcements 
  • Notification about a technical problem 
  • Information about medicines registration 
  • Order on approval of the price list of paid services provided by the Scientific Center of Drug and Medical Technologies Expertise N 029-A-22 of February 14, 2022 
  • Announcement about medicine registration by EAEU rules 
  • Announcement  
  • When should be submitted application for renewal 
  • Information about national procedure registration  
  • Information about ATC code 
  • Announcement on documents submitted to the Scientific Center in connection with the coronavirus epidemic in the Republic of Armenia (18.03.2020) 
  • Announcement about variation assessment payment 
  • Announcement about approval of the requirements for the responsible person of wholesale distributor for good distribution practice 
  • Announcement about approval of the requirements of labeling and packaging for medicinal products, pharmaceutical substances, herbal raw materials, investigational medicinal products, as well as for the patient leaflet, summary of product characteristics and trade names of medicinal products, and on excipients that must be indicated on the secondary packaging (Updated 07.02.2020) 
  • Training on ICH Stability Guidelines 
  • About Pharmacovigilance training which took place on July 9, 2019 
  • Information about the availability the SmPC and Package Leaflet in Armenian language in case of re-registration of medicines 
  • Information about documents accompanied to the registration certificate of the medicine 
  • The notification regarding the e-mail  
  • Analytical Laboratory SCDMTE took the first place for interlaboratory comparative tests (professional testing - Proficiency testing study - PTS), organized by the international organization LGC 
  • Order 1997-А/29.06.2016 on medicine withdrawal from circulation 
  • Orders 1547-А/23.05.2016 and 1856-А/17.06.2016 on medicines withdrawal from circulation 
  • ISO/IEC 17025:2017  
  • Codeine not to be used in children below 12 years for cough and cold 
  • The safety information regarding the use of Xeloda® (capecitabine). 
  • The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has endorsed restrictions on combining different classes of medicines that act on the renin-angiotensin system (RAS) 
  • Letter concerning to timelines for adverse drug reaction reporting 
  • In addition to our letter N0401126314 dated on 30.10.2014 

VETERINARY DRUGS

• Veterinary_Medicines
  • Registration, Re-Registration, Variation Applications (Updated 11.11.2022)
  • Veterinary medicinal products registration dossier presentation and format (15.07.2019)
  • Veterinary medicinal products re-registration dossier presentation and format (15.07.2019)
  • Notice to Applicants. Veterinary medicinal products (15.07.2019)
  • List of registred veterinary medicinal products in Armenia (up to 30.09.2022)