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)

Dear Sir/Madam,

We would like to inform you that on January 21, 2020, the Ministry of Health adopted Order N02-N “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.”

When compiling the registration dossier of medicinal products, as well as the relevant documents of pharmaceutical substances, herbal raw materials, investigational medicinal product it is necessary to comply with this order (the bases are attached).

 

 
Download this file (Order-32-N.pdf)Download[Order 32-N/14.06.2017/File available in armenia]
Download this file (88.PDF)Download[EAEU_Decree N88/03.11.2016/File available in russian]
Download this file (76.pdf)Download[EAEU_Decree N76/03.11.2016/File available in russian]
Download this file (2.pdf)Download[EAEU_Decree N2/29.01.2019/File available in russian]
Download this file (13.pdf)Download[EAEU_Decree N13/23.04.2019/File available in russian]
Download this file (02_N_eng.pdf)Download[Order 02-N/21.01.2020/File available in armenian]