Dear colleagues

We would like to inform, that on December 8, 2024 entered into force Decree of the Government of the Republic of Armenia N 1873-N of November 28, 2024 “On making changes and additions in Decree of the Government of the Republic of Armenia N162-N of February 28, 2019”: https://www.arlis.am/DocumentView.aspx?docid=200384

The processes with the amendments and additions made have been harmonized with the provisions of the "On Medicines" and "On State Duty" Laws, as well as with the EAEU procedures.

In particular:

The applicant submits the document confirming the payment of the state fee charged for the issuance of the registration certificate upon receipt of the notification of the assessment results.

In the case of submitting data on all strength(s), manufacturing site(s) and use, packaging and presentation form(s) simultaneously within the framework of one application for registration (re-registration, extension of the certificate validity period), as well as for the purpose of harmonizing the registered medicine dossier, a single state fee will be paid within the framework of one assessment.

The registration process for veterinary medicines in the Republic of Armenia within the framework of the EAEU has been regulated. 

During the re-registration and renewal assessment of the registration certificate, the data related to the medicine will remain in the register after the expiration of validity the previous certificate.

Thank you for your cooperation