Each CIS country has its own specific rules and registration process. Universalization of requirements to
registration documents and dossiers is one of the most acute issues in simultaneous registration of analogues in
different countries. Nevertheless, in such countries as Ukraine, Kazakhstan, Moldova and
Uzbekistan, all materials of the registration dossier, by and large, can be divided into 2 groups:
1) Studies and
tests that must be conducted in the country where the registration is being conducted (as a rule, biological
efficacy tests and studies of pesticide residues).
2) Studies that can be conducted both in local research
institutions and in institutions in other countries (or only in other countries).
Studies of the second type require special attention, in particular when registering products in Kazakhstan, Moldova
and Uzbekistan. Since these countries do not have research institutes accredited to conduct toxicological studies,
the applicant is obliged to submit reports performed by accredited research institutes abroad.
In this case there is
a problem of equivalence of national registration requirements, mutual recognition of research results, examination
of reports, confirmation of the status of laboratories.It should be noted that there are no legislative documents
designed to regulate such procedures at the state level.
Decisions are often made taking into account the
peculiarities and specific circumstances of each individual case and are based on previous experience or expert
opinion.
The registrant usually has several options when selecting a location for toxicological and ecotoxicological
testing.
How attractive is an option in terms of price/quality? In which countries can the studies be accepted for review? In which countries can they currently be used? Polgar ACRO will help to adequately assess the alternatives and develop a strategic plan involving the optimal solution for conducting the studies and preparing the registration dossier. Thanks to the umbrella structure, in case of synchronized registration in different countries, the client only needs to communicate with Polgar ACRO's central office in Budapest or one of the national offices, from where the work of all departments will be coordinated. For all questions arising within the framework of a particular registration, without exception, the client communicates with the single specialist responsible for the project.