Dear Sir/Madam,

Considering the fact that according to the new law “On Medicines”, discussing in the National Assembly, the registration dossier of a medicinal product should be submitted in the common technical document format (CTD), hereinafter it is recommended to follow attached list (Appendix 1) and guideline (Appendix 2) while compiling new registration dossier. The use of the logically structured format not only improves the effectiveness and transparency of expertise, but also contributes to registration of safe, good quality and effective medicinal products providing in separate sections detailed data on finished product, as well as active substance and excipients. Similar structure is also planned for documents submitting for registration of medicinal products in the framework of the Eurasian Economic Union. 


Appendix 1 updated 23.04.2019.

Download this file (0101176716-eng.PDF)Download[0101176716/27.04.2016]
Download this file (Appendix_ 1_list_ of_ documents_eng.pdf)Download[Appendix 1, List of documents/INVALID]
Download this file (Appendix_2_ Notice to Applicants_eng.pdf)Download[Appendix 2, Notice to Applicants]
Download this file (Registration dossier presentation and format_CTD_arm_22.04.2019.pdf)Download[Appendix 1, List of documents/VALID FROM 03.04.2019/File available in armenian]