Marina Losenko
Lawyer

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License for veterinary drugs manufacturing

License for veterinary drugs manufacturing

What we do

  • 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.

OUR FEES

With one available place of economic activity
UAH 8,000
For each another place of economic activity
+ UAH 6,000

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 (from 12.2019 - 2102 UAH.)

The license for manufacture of veterinary drugs is 15-20 working days.

WHY CHOOSE US

  • plus

    Our lawyers monitor not only the changes in the legislation, but also the practice of the licensing authority

    Legislation on the licensing of the manufacture of veterinary preparations has changed frequently in recent years. The very license for this type of economic activity was now revoked, then reinstated. New licensing terms have come into force since October 2018 and this economic activity is again subject to licensing. Our company has been keeping an eye on the events all the time and is following the laws and practices of the licensing authority.
  • plus

    By turning to us, you only need to sign the documents prepared by our lawyers.

    We will prepare all the documents for submission on the basis of the information you provide, as well as assist in the development of the files of the manufacturer of veterinary drugs, the sample of which has not been approved by anyone, and the requirements of the legislation thereto are quite abstract.

ANY QUESTIONS LEFT?

Our lawyers will advise you!

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Documents and information required to obtain a license for the manufacture of veterinary drugs

  • EDRPOU code of the legal entity or an ID number and passport information of a sole trader
  • Scans of the paperwork for the facility
  • Scans of the paperwork for staff

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).

REFERENCES FROM OUR CLIENTS

L. Chervonyuk, LLC "Vitalux"

Vitalux company highly appreciates results of cooperation with Law firm “Pravova dopomoga”, can characterize it as a reliable partner and based on personal experience is ready to recommend it to interested persons...... More information

General director I.Logvinenko , Bravo Airways

Bravo Airways company expresses its gratitude to law firm "Pravova Dopomoga" for high quality and timely provision of legal services.
... More information

President Tedeev E.S., Ukrainian wrestling association

Ukrainian wrestling association would like to express its sincere appreciation to the team of Law firm "Pravova Dopomoga" for mutually beneficial cooperation... More information

Partner, Denis Y. Lysenko, Vasil Kisil & Partners

... we would like to express our respect and gratitude for the fruitful cooperation.
... our work on joint projects assured us of your high level of professionalism
... More information

Chief ophthalmologist of Ukraine, Oksana Vitovska, All-Ukrainian alliance of ophthalmologists

We would like to express sincere gratitute to the team of Law firm "Pravova dopomoga" and personally to Volodymyr Gurlov for professionalism and purposefulness in your work.... More information

General director Skibinskiy V., Yokogawa Electric Ukraine Ltd.

Yokogawa Electric Ukraine Ltd. recommends Vladimir Gurlov and his team of lawyers as a reliable legal partner and advisor for foreign businesses in Ukraine...... More information

General Manager Stashkevych I.Y., LLC “Trading company” Rud”

We would like to indicate that law firm "Pravova Dopomoga" has become a reliable partner for legal services provision and we can recommend it as a team of qualified professionals who are easy and pleasant to deal with... More information

Important to know

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 FAQs

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.

SWIFT OBTAINMENT
AND BEST QUALITY PROVEN BY YEARS OF PRACTICE!

Volodymyr Gurlov, Managing partner

Volodymyr Gurlov, Managing partner

RELEVANT INFORMATION

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.

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