Re-registration dossier presentation and format (Updated 15.05.2019)

Updated 15.05.2019

 Dear colleagues,

We will be inform you that in case of re-registration of medicines under the national procedure  untill  31.12.2020 the presence of  SmPC and Package Leaflet into Armenian language is not mandatory. Translation and adaptation of these documents into Armenian language will be carried out in the period up to 31.12.2025, as part of the procedure of bringing the registration dossier of the drug in accordance with the requirements of the EAEU.

 
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