Where to register a veterinary drug in Ukraine?

Any activities related to the sale, import or manufacture of veterinary medicines in Ukraine are subject to state registration, which raises the following question, How to do it and how difficult can it be?

The main snag in the process is that the registration of a drug for veterinary purposes involves drawing up a fairly large list of documents, including the Dossier of the drug, as well as passing several examinations.

After passing one expertise, with the slightest mistake in the documents you may not pass another, which means you have to start the whole process over again. That’s all a waste of time and money.

We offer you the assistance of qualified lawyers who will take care of all organizational issues, as well as the development of separate documents for the registration of veterinary products. We will not only help you with the registration, but also look at your situation in general: we will provide necessary advice on your activities, help with the import of medicines into Ukraine, etc.

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The registration procedure for veterinary drugs in Ukraine

Registration of veterinary drugs consists of three stages. The procedure is quite long and complicated; in order to register a drug it is necessary to determine which type of drug is to be registered:

• veterinary;

• immunobiological.

The state institution, where you need to submit documents at the initial stage, depends on the type of the drug.

Let’s consider in detail each stage of registration of a veterinary drug in Ukraine.

Stage 1: Submission of an application to a state authority

Depending on the type of drug, you will need to submit a number of documents to one of the state authorities:

• The National Agency on Veterinary Drugs;

• The National Agency for Veterinary Immunobiological Preparations.

However, both agencies require the same set of documents:

• a application for an expert evaluation of the drug;

• a Registration Dossier of the veterinary drug. 

Please note! A properly executed Registration Dossier is the key to success when registering a veterinary drug. The Dossier must be submitted together with a sample of the drug and requires all the necessary certificates confirming the drug’s quality and compliance with the standards. 

Consideration of Registration Dossier at the first stage takes about 6-7 months. During this time, the agency may need additional supporting documents, which the applicant must provide, otherwise the decision at the third stage will remain at the “under consideration” stage. 

Stage 2: Obtaining recommendations from the National Pharmacological Commission 

During this period, the agency conducts its own review and sends the results to the State Pharmacological Commission of Veterinary Medicine, which makes recommendations to the agency on whether the drug should be registered, after which the agency issues its final conclusions.

The agency sends the documents on its own; the manufacturer or distributor of the drug does not need to contact the Commission at all. But you can monitor the procedure, as well as respond in time to the comments of one institution or another.

Stage 3: The decision of the State Committee of Veterinary Medicine

The Agency sends all the documentation to the State Committee of Veterinary Medicine, which at the third stage decides on the registration of the drug. 

The certificate of registration is issued, and the veterinary drug is registered within 30 days after the registration decree is issued.

Please note! The certificate will be issued for 5 years, after this period you need to conduct the re-registration procedure.

Collection and preparation of all necessary documents for the Registration Dossier is a complicated procedure, which is almost impossible to carry out alone, so we are ready to help you with it. We should note right away that the most difficult moment in preparing for the registration procedure is the compilation of the Dossier - most questions and comments are connected with its filling and  execution. 

We offer you our experience in drawing up a Registration Dossier for a veterinary drug, as well as our knowledge of the procedure for the successful registration of veterinary drugs in Ukraine.

Do you need assistance with the registration of a veterinary drug in Ukraine? Don’t hesitate to contact us! We will not only help you with the preparation of documents, but also take care that you  successfully pass examinations and evaluations of state institutions, constantly staying in touch with them.

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Everything about the Veterinary Drug Registration Procedure in Ukraine here.