Production of veterinary drugs

Production of veterinary drugs

Methods of obtaining a license to conduct business activities for the production of veterinary drugs:

1) In electronic form from 05/26/2022 in accordance with the procedure established by the Resolution of the Cabinet of Ministers of Ukraine dated March 18, 2022 No. 314 “Some Issues of Ensuring the Conduct of Economic Activities under Martial Law” . The declaration can be submitted in electronic form via the link .

List of business entities that have acquired the right to conduct business for the production of veterinary drugs on the basis of a declaration.xlsx ( . xlsx , 11.82 KB )

For clarifications regarding submitting a declaration in electronic form, or obtaining information about the presence of your data in the specified list, we recommend that you contact the State Service for Food, Drug and Consumer Protection at 044-278-44-47.

2) In paper form in accordance with the procedure established by the Resolution of the Cabinet of Ministers of Ukraine dated October 3, 2018 No. 808 “On Approval of the Licensing Conditions for Conducting Economic Activities for the Production of Veterinary Drugs” .

License register of the State Service for the Supervision of Food and Consumer Protection for the production of veterinary drugs (1 B. Grinchenko St., Kyiv, 01001, EDRPOU code - 39924774):

• Information on the decision of the State Service for Food and Consumer Protection of Ukraine to issue a license for conducting economic activities for the production of veterinary drugs in 2018 - 2025 ( . xlsx , 127.53 Kb )

Orders on decisions made by the State Service for Food and Consumer Protection of Ukraine regarding the issuance of licenses for conducting economic activities for the production of veterinary drugs for 2018: 26.pdf ( . pdf , 3.55 MB ) , 28.pdf ( . pdf , 2.26 MB ) ; for 2019: 14.pdf (. pdf , 1.20 MB ) , 36.pdf (. pdf , 1.21 MB ) , 63.pdf (. pdf , 1.08 MB ) , 103.pdf (. pdf , 1.29 MB ) , 151.pdf (. pdf , 2.21 MB ) , 209.pdf (. pdf , 873.10 KB ) , 348.pdf (. pdf , 1.25 MB ) , nakaz-425.pdf (. pdf , 533.32 KB ) , 589.pdf (. pdf , 1.68 MB ) , 660.pdf (. pdf , 895.20 KB ) , 726.pdf (. pdf , 1.22 Mb ) , 1162.pdf ( .pdf , 841.44 Kb ) , 1221.pdf ( .pdf , 707.47 Kb ) ; for 2020: 96.pdf (. pdf , 1.02 MB ) , 408.pdf (. pdf , 647.42 KB ) , 492.pdf (. pdf , 663.03 KB ) , 535.pdf (. pdf , 790.40 KB ) , 561.pdf (. pdf , 49.60 KB ) , nakaz-608.pdf (. pdf , 837.34 KB ) , 767.pdf (. pdf , 712.23 KB ) , 807.pdf (. pdf , 825.73 KB ) , 835.pdf (. pdf , 941.88 KB ) ; for 2021: 31.pdf (. pdf , 837.59 KB ) , nakaz-157.pdf (. pdf , 850.36 KB ) , nakaz-190.pdf (. pdf , 813.13 KB ) , 284.pdf (. pdf , 559.58 KB ) , nakaz-344.pdf (. pdf , 590.99 KB ) , 522.pdf (. pdf , 996.98 KB ) , nakaz-644.pdf (. pdf , 6.70 MB ) , 86429122021.pdf (. pdf , 990.42 KB ) ; for 2022: nakaz-32.pdf ( . pdf , 2.57 MB ) ; for 2023: order 712.pdf ( . pdf , 1.34 MB ) ; for 2024: order 111 ( . pdf , 1.81 MB ) , order 630 ( . pdf , 1.19 MB ) , order 871 ( . pdf , 1.24 MB ) .

General information

• Issuance of a license - granting a business entity the right to conduct a type of economic activity or part of a type of economic activity subject to licensing, by means of a decision by the licensing authority to issue a license, which is recorded in the license register;
• License - the right of a business entity to conduct a type of economic activity or part of a type of economic activity subject to licensing;
• License cost - a one-time fee for issuing a license is paid by the licensee no later than ten business days from the date of publication of the decision to issue a license in the amount of one subsistence minimum, based on the amount of the subsistence minimum for able-bodied persons in effect on the day the licensing authority makes the decision to issue a license (in 2026, from January 1 - 3328 hryvnias).
• State Register of Veterinary Drugs EN
• Registo Estadual de Medicamentos Veterinários PT
• Registre national des médicaments vétérinaires FR
• Overview of legislation in the field veterinary medicines (veterinary preparations)
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phone:

044-278-44-47

email address:

license@dpss.gov.ua

address: 
1 B. Grinchenko St., Kyiv, 01001, room 324

Working hours:

Monday-Thursday: 9:00 - 18:00;

Friday: 9:00 - 16:45

Lunch break: 13:00 -14:00

Information on license issuance, renewal and termination, suspension, renewal, closure of proceedings:

• The business entity submits to the structural unit of the State Food and Drug Administration ( room 324, 3rd floor) documents for obtaining a license, the form and list of which are approved by the Resolution of the Cabinet of Ministers of Ukraine dated November 4, 2015 No. 896 “On Approval of the Licensing Conditions for Conducting Economic Activities in Veterinary Practice” and dated October 3, 2018 No. 808 “On Approval of the Licensing Conditions for Conducting Economic Activities in the Production of Veterinary Drugs”.
• Documents are accepted by responsible officials, a note is made in the description about their acceptance, and an entry is made in the application registration journal.
• Within 3 working days, the received documents are reviewed for the presence of grounds for leaving the application without action, without consideration, or closing the proceedings.
• Within 10 working days, the received documents are reviewed for the presence of grounds for refusal to consider. In the absence of grounds for refusal and leaving the proceedings without action, without consideration or closure, the licensing authority makes a decision to issue a license. In the presence of the indicated grounds, the licensing authority makes a decision to refuse or leave the proceedings without action, without consideration or closure.
• In the event of submission of an application for termination of the license, the licensing authority shall make a decision to terminate the license within five working days from the date of receipt of such application.
• The license is renewed upon submission of an application for renewal in connection with the inheritance of the right to conduct the specified type of economic activity, provided that the material and technical base complies with the Licensing Conditions for Conducting Economic Activities in Veterinary Practice and the submission of documents confirming the right to inheritance. Such a decision is made within 1 month from the date of receipt of the application.

List of regulatory legal acts regulating the conduct of the type of economic activity for the production of veterinary drugs

• Licensing of business activities for the production of veterinary drugs
• Law of Ukraine "On Licensing of Types of Economic Activities"
• Law of Ukraine "On Veterinary Medicine"
• Resolution of the Cabinet of Ministers of Ukraine “On Approval of Licensing Conditions for Conducting Economic Activities for the Production of Veterinary Drugs”
• Resolution of the Cabinet of Ministers of Ukraine “On approval of the criteria by which the degree of risk from conducting economic activities in the production of veterinary drugs is assessed and the frequency of implementation of planned state supervision (control) measures by the State Service for Food Safety and Consumer Protection is determined”
• Order of the Ministry of Agrarian Policy “On approval of unified forms of acts drawn up based on the results of conducting a planned (unplanned) state supervision (control) measure over the licensee’s compliance with the requirements of the Licensing Conditions for conducting economic activities for the production of veterinary drugs and veterinary practice” dated 08.04.2022 No. 212, Registered with the Ministry of Justice of Ukraine on April 22, 2022 under No. 448/37784
• Order of the Ministry of Agrarian Policy dated 10.11.2017 No. 606 “On approval of the Regulation on the basic requirements for the production of veterinary drugs and the Rules of good manufacturing practice of veterinary drugs”, registered with the Ministry of Justice on 24.01.2018 under No. 106/31558