New rules for the registration of veterinary medicines in Ukraine in 2022
On February 4, 2021, Ukraine adopted a law regulating veterinary medicine, including certain procedural aspects of registering veterinary medicines. The law has already been enacted, but will be introduced gradually.
Our company helps people who want to obtain a registration certificate for a veterinary drug, so we closely monitor the relative changes in legislation. Today, our lawyer will analyze and give his legal opinion concerning the new rules of veterinary medicines registration in Ukraine.
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What changes have been made to the veterinary drug registration procedure in Ukraine?
The law on veterinary medicine was adopted to regulate certain issues, including the registration of veterinary medicines. It is aimed at:
shortening the timeframe for issuing registration documents;
digitalizing the corresponding sphere of relations — that is, we can expect the issuance of approvals in the veterinary field online;
protecting intellectual rights to invented new veterinary medicines in Ukraine;
strengthening liability for violations in the areas of veterinary medicine and animal handling.
But first of all we are interested in the changes that have been made to the procedure and whether it will become easier and faster to register a new veterinary drug in Ukraine. Let's highlight the most significant innovations that the new law promises:
Certificates of registration of veterinary medicines will be issued for an indefinite period of time, not for 5 years as before — which means that they will not need to be extended by going through a lengthy registration procedure all over again;
Only a Ukrainian legal entity will be able to apply for registration. That is, if the owner of the Dossier is a foreign person, he will need a Ukrainian intermediary company to work legally in Ukraine and register the veterinary medicine;
There is an annual fee for post-registration monitoring — 1 minimum wage in Ukraine;
Depending on the type of application for a drug registration (type of drug), there will be additional requirements for registration.
A separate important innovation in veterinary medicine will be the fact that the import, wholesale and retail sale of veterinary medicines, not only the activities related to the production of veterinary drugs, will be subject to licensing.
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The cost of veterinary drug registration in Ukraine
We not only closely monitor all changes in veterinary medicine, but also use our experience and knowledge in practice, offering our Clients assistance in obtaining veterinary licenses or registering veterinary medicines.
Our services include:
Introductory consultation on the registration procedure of a veterinary drug;
Drafting a “RoadMap” for drug registration in Ukraine, taking into account the peculiarities of the Client’s case;
Assistance in working out the Registration Dossier for a veterinary drug;
Preparation and submission of documents for veterinary drug registration;
Monitoring of the documents consideration.
The cost of registering a veterinary drug in 2021 will depend on the scope of legal services you need:
Would you like to get a “RoadMap” — a step-by-step guide for registering your particular veterinary drug in Ukraine?
Do you need legal assistance with the development of the Dossier of a veterinary drug?
Do you need legal support of the registration procedure?
You can check the price of the service package you need with our specialist by phone or by any other convenient ways. Learn more about the service here.
Do you need legal assistance with the registration of a veterinary drug in Ukraine or drawing up a Dossier? Don’t hesitate to contact us! We will help you to obtain the necessary certificate to safely start your business activity in Ukraine.
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