License for veterinary drugs manufacturing
Cost of services
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What we offer
- we advise the Client on the issues relating to the obtainment a license for veterinary drugs manufacturing, including issues related to the personnel qualification and the compliance of the premises with the license conditions;
- we assist with the choosing of premises for the implementation of activities on veterinary drugs manufacturing;
- we provide assistance with the development of dossier of the manufacturer’s division;
- we fill out all the necessary documents and submit them to the licensing authority under power of attorney on behalf of the Client without his personal presence;
- we accompany documents review in the licensing authority;
- in case of problem situations during the documents review we take charge of their solving.
Documents and information required to obtain a license for the manufacture of veterinary drugs
To prepare the license application documents, you must have:
- Scan copies of the paperwork for the facility: documents of ownership (certificate of ownership, extract from the state register of real estate rights) or a lease / sublease agreement; the technical passport of the facility (or simply a plan of the facility, indicating its characteristics and the area of ??each room);
- Scan copies of documents for staff: diplomas, certificates of advanced training, employment books;
- A scan copy of the Unified State Register statement (or just a legal entity's EDRPOU code or a sole trader’s identification number);
- A scan passport copy (for sole traders);
- A power of attorney for our employees (we provide the text for the power of attorney).
Service packages offers
- What is required to obtain a license for the production of veterinary drugs?
- Information on staff qualifications and compliance of the premises with the license conditions
- How long will the licensing process take and what benefits will we provide?
- Preliminary analysis for compliance of the premises (according to the technical certificate) and qualification of the personnel with the license conditions
- Preliminary analysis of your manufacturer's site file
- Preparation of the application, information and formation of a package of documents for submission
- Submission of documents to the licensing authority and support of the review
- In case of remarks of the licensing body - their prompt correction
- Obtaining a decision on the issuance of a license and providing details for the state fees
- Preliminary analysis for compliance of the premises (according to the technical certificate) and qualification of the personnel with the license conditions
- Individual development of the manufacturer's site dossier by our lawyers
- Preparation of the application, information and formation of a package of documents for submission
- Submission of documents to the licensing authority and support of the review
- In case of remarks of the licensing body - their prompt correction
- Obtaining a decision on the issuance of a license and providing details for the state duties
Legal consultation on obtaining a license for the production of veterinary medicines in Ukraine
If you want to clearly understand the stages and procedure of obtaining a license for the production of veterinary drugs in Ukraine, we recommend applying for an introductory consultation with our lawyers. Our specialists will answer the following questions:
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What is needed in order to obtain a license for a veterinary drug in Ukraine?
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What are the requirements for staff and premises?
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How long does it take to obtain a license and what benefits do we offer to our Clients?
If you want to get more information, for example, on how the process of manufacture of veterinary medicines in Ukraine, you can order "Road map". It represents a step-by-step algorithm of steps for solving the Client's problem, which lawyers will develop individually for each situation. The cost of the "Road Map" can be obtained from our specialists.
The cost of services for obtaining a license for the production of veterinary drugs does not include services for the development of a dossier for the manufacturer's site. If necessary, we can provide this service as well.
The cost of our services does not include the cost of notarization (required only for sole traders) and the state payment for the license.
The amount of the state payment is one subsistence minimum for able-bodied persons.
The license for manufacture of veterinary drugs is 15-20 working days.
Why us
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Contact us by mail [email protected] or by filling out the form:Our successful projects
In order to carry out the economic activity of the manufacture of veterinary drugs, a legal entity must have at least one veterinary specialist, and an individual entrepreneur must this specialist themselves.
However, licensing terms stipulate that the manufacturer of veterinary drugs must have an authorized person. This can be a person with a higher education degree in one of the following specialties:
- “Pharmacy, industrial pharmacy”;
- “Veterinary medicine”;
- “Chemical Technology and Engineering”;
- “Biotechnology and Bioengineering”;
- “Biomedical Engineering”;
- "Chemistry";
- "Biology".
In addition, the authorized person must have at least two years' experience in the field of manufacturing, quality control or production of veterinary medicinal products.
Answers to frequently asked questions
What are a veterinary drug manufacturer's facility files and where to get them?
The files for the veterinary drug manufacturer’s facility are a detailed description by the manufacturer of the facility where the production of the veterinary drugs will be carried out or their quality will be checked. These files should include information about the nature of the activity (e.g. review of veterinary drugs). In addition, information on the surrounding production sites and the nature of the work carried out must be provided.
If a person is licensed for a veterinary practice and wants to mix certain substances for his or her activity, must he or she be licensed to manufacture veterinary drugs?
Yes, they must. According to the licensing conditions, governing obtaining a license for the manufacture of veterinary drugs, this license must be obtained, even if the person carries out at least one of the production stages, incl. - mixing substances.
Obtaining a license for the production of veterinary drugs
Once the Client has reached an agreement on the terms, cost and scope of work on obtaining a license for the manufacture of veterinary drugs, we enter into an agreement to provide legal services. Preparation of documents for submission begins after receipt of one hundred percent advance payment, as well as documents and information necessary for preparation.Documents prepared by our specialists are sent to the Client's e-mail for approval and signing. If the Client is not in Kyiv, the signed documents can be sent to us by any courier delivery service.
Once a license decision and payment details are posted on the licensing authority's website, the licensee has 10 business days to pay the state fee. Although the law does not require proof of payment to the licensing authority, the latter still requests a copy of the receipt. Non-payment of the state fee in the allotted period may cause the license to be revoked. The original receipt must be kept by the licensee for the entire duration of the license. At the request of the Client, our employees can provide a copy of the receipt of the licensing authority.
The above procedure for obtaining a license for the manufacture of veterinary drugs may be modified in accordance with your request.
If you want to obtain a licence to manufacture veterinary medicines quickly and easily, call us!
