How to register a veterinary drug in Ukraine?
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In July 2020, we were contacted by a Client who was going to distribute foreign veterinary medicines. Our firm provides services to the veterinary business and assistance in obtaining a Veterinary Medicine License, so we know the registration procedure of veterinary drugs in Ukraine very well.
The Client was interested in the following questions:
- Do all veterinary drugs have to be registered in Ukraine?
- What does it take to register veterinary drugs in Ukraine?
- How long does it take to register veterinary drugs?
- What is the approximate price of registering a veterinary drug in Ukraine?
We offered the Client to develop a so-called service roadmap. This is the kind of written consultation in our company, when the Client is provided with:
- a step-by-step action guide;
- explanation of the steps;
- the calculation of expenses, if any.
Since this is not the only request for registration of veterinary medicines, we decided to elaborate on the procedure in more detail.
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Where shall veterinary medicines be registered?
Veterinary medicines are registered with the State Committee of Veterinary Medicine of Ukraine. But before getting to the committee, a veterinary drug goes through several authorities.
First of all, you need to determine whether a drug belongs to veterinary medicines, or medicinal immunological drugs. Depending on this, you should apply either to the National Agency of Veterinary Medicinal Products and Feed Additives, or the National Agency for Veterinary Immunobiological Preparations. Hereinafter, both authorities will refer to the “agency”, because the list of documents and procedures for the authorities are almost the same.
Stage 1: Drug research study by the agency.
The list of documents to be provided to the agency:
- an application for a drug research study
- a marketing authorisation file.
More about the marketing authorisation file. A detailed description of the marketing authorization file is provided by the Order of the State Committee of Veterinary Medicine No. 133 of 14.07.2008.
The marketing authorization file of a veterinary drug is a set of analytical and regulatory documents and specialized assessment documents:
- certificates of accreditation;
- safety instructions;
- clinical trial materials.
It must specify:
- qualitative and quantitative composition of active components;
- indications and contraindications;
- side effects;
- actions in case of overdose;
- manufacturer information (ISO certificate, GMP certificate.
In addition, the marketing authorization file must contain samples of the drug.
Please note! The entire process depends on the correctness of the file and completeness of information specified therein.
The period of conducting the drug research study by the agency. The agency has 210 days following the date of receipt of the application, the full set of documents, and the corresponding payment.
The price of the research study. The agency independently determines the necessity and scope of conducting registration tests. This means that the invoice for each specific drug is issued individually, based on a preliminary assessment of its characteristics.
After conducting trials, the agency prepares an expert opinion.
Stage 2: Assessment of the File by the State Pharmacological Commission of Veterinary Medicine of Ukraine.
In fact, this assessment is part of the previous stage, as it takes place before the expert opinion is drawn up. However, it has such an important impact on the process that we will take it to a separate stage.
Before the expert opinion is drawn up, the agency submits preliminary results of tests and evaluation of the marketing authorization file to the State Pharmacological Commission of Veterinary Medicine, which reviews these preliminary results and submits recommendations to the agency as to whether the drug should be registered.
After that, the agency prepares an expert opinion taking into account the recommendations of the State Commission for Veterinary Medicine and submits a package of documents to the State Pharmacological Commission of Veterinary Medicine.
Thus, it turns out that you personally do not come into contact with the State Pharmacological Commission of Veterinary Medicine and do not submit any documents, but it is the agency that provides preliminary recommendations on registration or rejection of registration of veterinary medicines.
In this situation you should know that the lack of need to communicate with the State Pharmacological Commission of Veterinary Medicine does not mean that you can not at least monitor the development of events. Our lawyers can help you with this.
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Stage 3: Decision of the State Committee for Veterinary Medicine of Ukraine.
The final decision on the registration of veterinary medicines, or rejection of registration, is made by the State Committee of Veterinary Medicine, based on the documents received from the Agency (in particular, the expert opinion).
After registration, the Committee issues a registration certificate in the name of the owner of the marketing authorization file. The validity period of registration may be up to five years, after which the re-registration is required.
As for our Client, we helped him to estimate the period and price of registration of his veterinary drug, and then proceeded to the direct registration procedure. We also provided advice on the possibility of importing veterinary drugs from abroad to Ukraine.
If you want to register veterinary medicines or drugs in Ukraine, don’t hesitate to call us. We will help you to understand the procedure and provide professional support during registration.