Registration of a veterinary drug in Ukraine
Cost of services
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What we offer
develop a Veterinary Drug Registration RoadMap;
provide assistance in preparing the Registration Dossier for a veterinary drug;
submit the package of documents to the appropriate agency for registration of a veterinary drug in Ukraine;
monitor the consideration of documents by the agency, always being in touch in case intervention is needed;
obtain a Registration Certificate for the veterinary drug for the Client on its behalf.
How much does it cost to register a veterinary drug in Ukraine?
The cost of conducting research for each drug is determined individually and depends on its composition. Until documents are submitted, it is difficult to estimate a preliminary cost. In practice, the average research may cost 4,000 dollars.
This amount is not included in our veterinary drug registration services.
The price of registering a veterinary drug with our lawyers will depend on the exact scope of services you need:
Do you need help with developing a Dossier for a veterinary drug?
Do you only need a RoadMap - step-by-step instructions for conducting registration on your own, or do you want professional assistance at all stages of the registration procedure?
Is the timeframe for registration of a veterinary drug critical to you?
The period of registration of a veterinary drug in Ukraine is 8-10 months.
What do you need to register a veterinary drug in Ukraine?
To register a veterinary drug, you must submit an application for registration and a Registration Dossier.
The Registration Dossier of a veterinary drug is a set of analytical and regulatory documents, documents of specialized evaluation (accreditation certificates, safety and residue instructions, materials of clinical trials). The successful registration of a veterinary medicinal product depends primarily on its correct compilation.
The detailed description of a Registration Dossier can be found in the Order of the State Committee on Veterinary Medicine № 133 of 14.07.2008. In brief, the Dossier shall contain qualitative and quantitative composition of active ingredients, indications and contraindications, side effects, doses, instructions in case of overdose, etc., as well as information about the manufacturer (ISOcertificate, GMP certificate).
Having experience in developing this type of documents, our lawyers offer their services in drawing up and checking the Dossier of a veterinary drug, as this preparation will allow you to be sure that your drug will be successfully registered without delays or other problems.
Peculiarities of the veterinary drug registration procedure in Ukraine
How to register veterinary medicines in Ukraine? The veterinary drug registration procedure consists of several stages, each of which requires you to get prepared in advance. We will draw your attention to the key points of the registration process, you can check full details with our specialists at a personal consultation.
The veterinary drug registration procedure will look as follows:
Stage 1. Preparation.
You will need to develop the Dossier, as well as prepare the other documents required for registration - the application for the examination of the drug.
Stage 2. Filing a Dossier and other documents.
The dossier of the veterinary drug and the application must be sent to the relevant Agency (depending on the purpose of the drug - veterinary or immunobiological), which analyzes the content of the Dossier and conducts research on the drug.
Depending on the type of veterinary drug, itr may be examined by the National Agency on Veterinary Drugs and Animal Feed Additives or the National Agency for Veterinary Immunobiological Preparations. One of these agencies issues an invoice and conducts research on a contractual basis.
Stage 3. Review of the Dossier by the Commission.
The Agency sends the results of the preliminary studies to the National Pharmacological Commission. This commission also reviews the case materials and provides its recommendations to the Agency.
Stage 4. Decision of the Committee on the registration of a veterinary drug.
After that, the Agency prepares an expert opinion and forwards the package of documents to the State Committee on Veterinary Medicine. It is the State Committee on Veterinary Medicine that makes the decision to register or refuse to register a veterinary product based on the expert opinion received. It’s worth noting that at this stage it is impossible to change anything and in case of refusal the money for the examination shall not be refunded.
Please note! The certificate will be issued for 5 years, after this period you need to conduct the re-registration procedure.
If you want to be sure that your money is not spent in vain, apply to our company beforehand. The only chance to influence the Committee’s decision is to draw up the documents correctly and in compliance with the legal requirements.
That is why the preparatory stage and the assistance of a qualified lawyer are very important in this case.
How to register veterinary drugs in Ukraine?The veterinary drug registration procedure consists of several stages. Depending on the type of veterinary drug, its research is carried out by the National Agency on Veterinary Drugs and Animal Feed Additives, or the National Veterinary Immunobiological Agency.
It is one of these agencies that issues the bill and carries out research on a contractual basis.
After getting recommendations from the State Pharmacological Commission of Veterinary Medicine, the agency submits a package of documents together with its expert opinion to the State Committee of Veterinary Medicine.
The State Committee of Veterinary Medicine takes a decision on registration or refusal to register a veterinary medicine product based on the expert opinion. Characteristically, at this stage nothing can be changed and, in case of refusal, money for conducting trials will not be refunded.
That is why the preparatory stage and the assistance of a qualified lawyer are very important at this stage.
We are ready to help you!Contact us by mail [email protected] or by filling out the form:
Legal services for the registration of veterinary medicines in Ukraine
If you first want to assess whether it will be profitable for you to start the registration procedure, you can order a consultation on the questions you are interested in.
Our company provides several formats of consultations:
A preliminary oral consultation is a consultation where you can discuss the key points of a particular procedure. For example, the registration of veterinary medicines. The lawyer will tell you what you need to do, what you need to prepare for, what you need to pay attention to, etc;
A RoadMap is a written peculiar step-by-step instruction on how to achieve the ultimate goal. After reading it, you can decide whether you will go through the procedure yourself or it will still be time-consuming for you, and it is better to entrust the work to professionals.
The cost of both types of consultation can be checked with our specialists by phone. See the phone numbers on our website.
Do you want to register a veterinary drug in Ukraine? Don’t hesitate to contact us! We will help both with the registration procedure and with advising on the import of the drug.
Answers to frequently asked questions
The registration price is affected by the complexity of the chemical composition of the drug, as based on this, the Agency conducts specific trials.
The legislation establishes that the period for consideration of submitted documents by the agency shall not exceed 210 days. If the dossier is prepared correctly and the drug is not complex, the trials may be completed more quickly.
Peculiarities of the veterinary drug registration procedure in UkraineThe dossier of the veterinary drug specified in the Documents block is submitted to the relevant Agency, which analyzes the content of the dossier and conducts the drug trials.
The results of previous trials are forwarded by the Agency to the State Pharmacological Commission of Veterinary Medicine. This commission also reviews the case files and provides its recommendations to the Agency.
After that, the Agency prepares an expert opinion and submits a package of documents to the State Committee of Veterinary Medicine. This committee decides on registration and registers the veterinary drug or refuses registration.
If you want to be sure that the invested money will not be wasted, please contact our company in advance. The only chance to influence the outcome of the Committee’s consideration is to correctly draw up the documents and prepare them in accordance with the requirements of the law.
Do you want to register a veterinary drug in Ukraine? Contact us and we will help you with registration as well as with consulting on import of the drug.