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Registration procedure in Kazakhstan. New regulations and difficulties the industry might meet: questions and answers
Once new registration requirements were introduced in 2012, everyone having or planning to have agrochemical business in Kazakhstan was interested in approximately the same basic but crucial rules. We have collected most frequently asked questions. Please, kindly find these questions answered below:
Q: How many producers of active ingredient and how many producers of product one may declare in his registration?
A: Only one of each. Only those that have actually manufactured for samples used for efficacy trials. No exceptions even if equivalence proved and even second toxicological dossier available.
However, when getting a license for import one can ask to import from another producer by providing:
- equivalence 5-batch report, translated to Russian, from valid, CIS certified or GLP Lab.
- licence for manufacturing from a new producer
- agreement, contract, between new producer and supplier
All translated to Russian
Q: Can one sell of transfer a registration in Kazakhstan? (and, in general to change reg. holder)
A: Yes, this is possible.
One have to provide the grounds for that. For example, buy-sell contract or documents on the companies merge, etc. Plus letters from both companies, one willing to shift, another to accept the registration. Plus original reg. certificate and label must be returned. Dossier must be also provided. If something is missing from the dossier (registration was old, and made acc. to old rules) then the parties will be obliged to complete the dossier first.
All documents to be in Russian.
Q: Can a foreign company be a registration holder in RK?
Q: Is it possible to register a second brand name?
Q: Is it possible to change a brand name after the registration is received?
A: NO. At the moment this is not possible. Perhaps this issue will be re-considered in the future, but the new regulations does not contain this procedure.
What one can do is to re-apply for a new registration with a same dossier and cancel the old one.
Q: Is it possible to cancel a registration?
A: Yes, as mentioned above, that is possible.
Q: Is it possible to register a product in task force or based on LoA to some's data?
A: No, that is not possible. However, one can register a product using someone's dossier and LoA to it, however, the reports must be submitted, not just the reference. Also, one would have to make their own efficacy trials and residue but the rest (tox, eco tox, hygiene of labor, etc) can be used.
Q: How can one change a producer?
A: One should provide a new dossier and repeat the trials. Usually it is better to do this during the re-registration process.