Registration of a veterinary drug in Ukraine
Cost of services
Cost of services:
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What we offer
- develop a "roadmap" for the process of veterinary drug registration;
- help with preparation of registration dossier for a veterinary drug;
- submit a package of documents to the appropriate agency;
- monitor the review of documents by the agency, always in touch in case you need to intervene;
- obtain a veterinary drug registration certificate for the Client, on his behalf.
To register a veterinary drug, the applicant shall submit an application for registration and a registration dossier.
Registration dossier is a set of analytical and regulatory documentation, specialized assessment documents (accreditation certificates, safety instructions and product residue, clinical trial materials).
Detailed description of what exactly the registration dossier should consist of is provided by the Order of the State Committee for Healthcare and Social Development No. 133 of 14.07.2008. In short, the dossier must contain qualitative and quantitative composition of active components, indications and contraindications, side effects, doses, overdose actions, etc., as well as information about the manufacturer (ISO certificate, GMP certificate).
The price of conducting trials for each drug is determined individually and depends on its composition. Until the documents are submitted, it is quite difficult to estimate the preliminary price. In practice, the average bill may be USD 4,000.
This amount is not included in the price of veterinary drug registration services of our company.
The registration period for a veterinary drug in Ukraine is 8-10 months.
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], by phone number +38 044 499 47 99or by filling out the form:
Legal services for registration of veterinary drugs in Ukraine
If you first want to assess whether it would be profitable for you to start the registration procedure, you can order a consultation on the questions you are interested in.
Our company offers several consultation formats:
- A preliminary oral consultation is a consultation where you can discuss the key issues of a particular procedure. For example, the registration of veterinary medicines. The lawyer will tell you what you need, what is worth preparing for, what to pay attention to, etc.;
- A roadmap is a written, step-by-step instruction on how to achieve your final goal. Once you familiarize yourself with it, you will be able to decide if you can go through the procedure yourself or if it will be labor-intensive and it is better to entrust the work to professionals.
You can learn the price of both types of consultation from our specialists by calling the telephone number indicated on the website.
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.