Drug registration — expertise of drug quality and efficacy for further sales on the territory of Ukraine (or CIS).
Services on registration of originators should include conduct of own preclinical and clinical studies. (You may read about studies here in more detail: Preclinical studies, clinical studies). And only after their successful completion, you may submit documents for registration.
Drug registration in Ukraine goes in several stages (in accordance with order of MoH №460 dated 23.07.2015):
— submission of an application to a single window;
— submission of a registration form to a scientific secretary, and payment of an official invoice from the Pharmaceutical Center of Drugs at the Ukrainian Ministry of Health;
— submission of a dossier to a scientific secretary;
— initial dossier expertise and referral to tests to the authorized laboratory of the State Expert Center of the Ministry of Health.
— after obtaining a laboratory conclusion, the dossier is submitted to secondary expertise to the pharmaceutical commission.
— one month after (or maximum -2), the pharmaceutical commission should either issue a remark or schedule for a meeting.
— after a meeting within a month, a registration dossier valid for 5 years is issued.
Specialists of our company will help to collect the entire set of documents for successful drug registration in Ukraine or CIS.
As well, specialists of our company will help to execute a Drug import license for foreign drugs.
Execution term: 2-5 months.
We work in all the regions of Ukraine, call right now — 073 070 2917