Registration dossier of a veterinary drug in Ukraine
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A client reached out to us with plans to import and market a veterinary product in Ukraine. They had questions about the necessary requirements, the cost of the registration procedure, and the duration of the process. Of particular interest to them was the development of a dossier, a crucial document that must meet stringent criteria.
To assist them, we proposed creating a detailed roadmap—a comprehensive written consultation that addresses their queries and more. By mapping out a precise action plan right from the beginning, we can provide an estimate of the project's cost and timeline.
Today, we will delve into the key aspects of the registration process, as this information will be valuable to all entrepreneurs looking to import veterinary products into Ukraine. However, if you seek personalized answers and recommendations for your specific project, please feel free to consult our experts for a tailored consultation.
So, what exactly is required for registering a veterinary product?
First and foremost, the manufacturer must possess a registration dossier. Additionally, the applicant needs to complete an application and submit a complete package of documents to the National Agency of Veterinary Medicines and Feed Additives at the State Scientific and Research Control Institute of Veterinary Medicines and Feed Additives.
For a more detailed overview of where to apply and how the entire process unfolds, we have already discussed it in-depth here.
What is the registration process for veterinary products in Ukraine?
This is a common question that arises before taking any steps, and it's understandable. However, providing a definitive answer with an exact figure is quite challenging. The reason is that the agency responsible determines the need and extent of registration trials on a case-by-case basis.
This means that the cost for each specific product is assessed individually, taking into account its unique characteristics. On average, research for a single product can range from ,000 to ,000.
It's important to note that the cost of legal services is separate from the registration fees. You can find more information about what is included in the service here.
You may also like: Which Products Require Mandatory Registration as Veterinary Medicines?
How long does the registration process for a veterinary product in Ukraine usually take?
The duration of the procedure can vary based on several factors, including the complexity of the product being registered.
According to the regulations, the agency responsible for registration has a maximum timeframe of 210 days to conduct the necessary research. However, it's important to note that the registration of feed additives tends to be faster, and there are certain simplifications in the process. Typically, the registration of a feed additive should be completed within 180 days.
What if there are challenges with the registration dossier?
The registration dossier is a comprehensive document that contains extensive information about the product, including:
- Manufacturing process
- Qualitative and quantitative composition of active ingredients
- Indications and contraindications
- Side effects
- Actions in case of overdose
- Information about the manufacturer (ISO certificate, GMP certificate), and more
Ideally, the manufacturer should provide all this information and the necessary documents. However, sometimes the registration process in the manufacturer's country may be less stringent, resulting in a lack of comprehensive printed or digital information (except in the memory of those involved in the process).
That's why we suggested to the client to develop the registration dossier from scratch, describing all the processes involved.
We have already provided more detailed information about what the section of the manufacturer's dossier should include.
It should provide a detailed and comprehensive description of everything, from manufacturer information to risk management. It should include a complete description not only of each room but also its specific functions, including storage conditions, heating, air conditioning, ventilation systems, temperature regimes, and humidity. Equipment used in the production area should be described as well. Additionally, special attention should be given to surface cleaning and treatment methods. If anything from the listed requirements is not covered, there is a high chance of receiving a remark from one of the competent authorities involved in the registration of the veterinary product.
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Everything about the registration of veterinary products in Ukraine here.