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License to engage in veterinary activities. Do I need a license for a veterinary clinic?

Decree of the Government of the Russian Federation of July 5, 2002 N 504
"On Approval of the Regulations on Licensing Veterinary Activities"

In accordance with the Federal Law "On Licensing Certain Types of Activities", the Government Russian Federation decides:

2. Establish that licenses for the implementation of veterinary treatment-and-prophylactic and laboratory-diagnostic activities, issued in accordance with the established procedure before the adoption of this resolution, are valid until the expiration of the period specified in them.

3. Recognize invalid the Decree of the Government of the Russian Federation of April 3, 1996 N 393 "On approval of the Regulations on licensing veterinary activities in the Russian Federation" (Sobraniye zakonodatelstva Rossiyskoy Federatsii, 1996, N 15, art. 1631).

Position
on licensing of veterinary activities
(approved by Decree of the Government of the Russian Federation of July 5, 2002 N 504)

With changes and additions from:

1. This Regulation determines the procedure for licensing veterinary activities carried out by legal entities, regardless of the legal form and individual entrepreneurs.

Veterinary activities include:

veterinary treatment-and-prophylactic and laboratory-diagnostic works;

electronic labeling of animals.

2. Licensing of veterinary activities is carried out by the executive authorities of the constituent entities of the Russian Federation at the place of registration legal entity or an individual entrepreneur (hereinafter referred to as the licensing authority).

3. Licensing requirements and conditions for the implementation of veterinary activities are:

a) compliance with the requirements of regulatory legal acts of the Russian Federation in the field of veterinary medicine;

b) the licensee has technically equipped premises that belong to him on the right of ownership or on another legal basis, necessary for the implementation of the licensed activity;

c) the presence in the staff of the legal entity of employees (veterinarians and paramedics) with higher or secondary professional education and specialized training in veterinary medicine;

d) an individual entrepreneur has higher or secondary education and special training in the field of veterinary medicine;

e) improving the qualifications of employees of a legal entity at least once every 5 years, as well as individual entrepreneurs performing veterinary activities.

4. To obtain a license, the license applicant submits the following documents to the licensing authority:

a) an application for a license, indicating:

name, legal form and location - for a legal entity;

last name, first name, patronymic, place of residence, details of an identity document - for an individual entrepreneur;

licensed activities that a legal entity or an individual entrepreneur intends to carry out;

b) copies of constituent documents and a document confirming the fact of making an entry about a legal entity in the Unified State Register legal entities;

copy of certificate of state registration citizen as an individual entrepreneur;

c) a copy of the certificate of registration of the license applicant with the tax authority;

d) a document confirming the payment of the license fee for consideration by the licensing authority of an application for a license;

e) information on the qualifications of the license applicant's employees.

If copies of documents are not certified by a notary, they are submitted with the presentation of the original.

It is not allowed to require a license applicant to submit documents that are not provided for by these Regulations.

5. The licensing authority makes a decision to grant or refuse to grant a license within a period not exceeding 60 days from the date of receipt of the application with all the necessary documents.

6. The license is granted for 5 years.

The validity period of a license upon its expiration may be extended at the request of the licensee in the manner prescribed for reissuing a license.

7. Control over compliance by the licensee with licensing requirements and conditions is carried out by the licensing body no more than once every 2 years by conducting scheduled inspections.

The activities of the licensee, during the scheduled inspection of which violations of license requirements and conditions are revealed, are subject to an unscheduled inspection, the subject of which is to control the implementation of instructions to eliminate the identified violations.

An unscheduled inspection of the fulfillment by the licensee of the license requirements and conditions is carried out by the licensing authority also in the event of:

obtaining information from legal entities, individual entrepreneurs, bodies state power about violation by the licensee of license requirements and conditions;

appeals of citizens, legal entities and individual entrepreneurs with complaints about the violation of their rights and legitimate interests in connection with the licensee's failure to comply with licensing requirements and conditions, its inaction, as well as the receipt of other information, supported by documents and other evidence, indicating the presence of signs of such a violation.

The duration of verification of compliance by the licensee with license requirements and conditions should not exceed one month.

This provision defines the procedure for licensing veterinary activities carried out by legal entities, regardless of the legal form, as well as individuals engaged in entrepreneurial activities without forming a legal entity.

In accordance with Decree of the Government of the Russian Federation of December 24, 1994 No. 1418 "On Licensing Certain Types of Activities" (Sobraniye Zakonodatelstva Rossiyskoy Federatsii, 1995, No. 1, Art. 69), licenses for veterinary activities are issued by the executive authorities of the subjects of the Russian Federation at the place of state registration of a legal entity or an individual entrepreneur (hereinafter referred to as licensing bodies).

The license is issued for the implementation of veterinary treatment and prevention, laboratory and diagnostic activities, as well as for:

production and sale of veterinary preparations manufactured by enterprises, laboratories, workshops;

production and sale of feed, feed additives, including non-traditional, mineral and vitamin supplements for animals, manufactured by enterprises, laboratories, workshops;

implementation medicines for veterinary purposes, biological preparations, zoohygienic products and veterinary attributes.

4. The licensee may simultaneously have several licenses to perform various types of veterinary activities.

The transfer of a license to another legal or natural person is prohibited. It does not apply to other persons carrying out activities jointly with the licensee, including under a cooperation agreement, as well as to legal entities, one of the founders of which is the licensee.

To obtain a license, the applicant submits to the licensing authority:

a) an application for a license, indicating:

for legal entities - the name and organizational and legal form, legal address, current account number and the corresponding bank;

for individuals - last name, first name, patronymic, passport data (series, number, when and by whom issued, place of residence);

type of activity indicating specific services and works;

the term of the license;

a list of territorially isolated facilities where the activity specified in the application will be carried out;

b) copies of constituent documents (if they are not certified by a notary - with the presentation of the originals);

c) a copy of the certificate of state registration of the enterprise;

d) a document confirming payment for consideration of the application;

e) editing tax authority on registration or certificate of state registration individual as an entrepreneur with a tax authority stamp;

g) the conclusion of the state veterinary service on the production base on which the applicant intends to carry out the type of activity specified in the application, as well as a list of available regulatory and technical documentation, the necessary technological equipment and tools for providing services and performing work in the field of veterinary medicine;

h) copies of documents confirming the professional readiness of the performers of the work;

i) the conclusion of the bodies of the Ministry of Internal Affairs of the Russian Federation on the technical condition of the premises for storing potent agents and equipping them with security alarms.

It is prohibited to require the applicant to submit documents that are not provided for in the following provision.

All documents submitted for obtaining a license are registered by the licensing authority.

7. The decision to issue or refuse to issue a license is made within 30 days from the date of receipt of the application with all the necessary documents.

In the case of an additional, including independent, examination, the decision is made within 15 days after receiving the expert opinion, but no later than 60 days from the date of submission of the application with the necessary documents.

In some cases, depending on the complexity and volume of materials subject to examination, the head of the licensing authority may extend the period for making a decision on issuing or refusing to issue a license for 30 days.

The decision to issue a license is made on the basis of the conclusion of the expert council (commission) of the state veterinary service of the relevant subject of the Russian Federation.

A notice of refusal to issue a license is sent to the applicant in writing within 3 days after the adoption of the relevant decision, indicating the reasons for the refusal.

The grounds for refusal are:

the presence in the documents submitted by the applicant of false or distorted information;

an expert opinion that established non-compliance with the conditions necessary for the implementation of the relevant type of activity, and safety conditions.

The license states:

the name of the authority that issued the license; for legal entities - the name and legal address of the enterprise, organization, institution receiving the license;

for individuals - last name, first name, patronymic, passport data (series, number, by whom and when issued, place of residence);

the type of activity for which the license is issued;

the term of the license;

conditions for the implementation of this type of activity;

registration number of the license and date of issue.

11. The license is signed by the head (in case of his absence, the deputy head) of the licensing body and certified by the seal of this body.

12. The license is issued after the applicant submits a document confirming payment of the license fee.

If the licensed type of activity is carried out at several territorially separate objects, the licensee shall be issued with a license simultaneously with its certified copies indicating the location of each object.

Copies of the license are registered by the licensing authority.

Activities on the basis of a license issued by authorities executive power subjects of the Russian Federation, on the territory of other subjects of the Russian Federation may be carried out after registration of this license by the executive authorities of the relevant subjects of the Russian Federation.

Registration is carried out within 30 days upon presentation of the original license, with verification, if necessary, of the conditions specified in the license for the implementation of the relevant type of activity and safety conditions. The license makes a note about the registration and entry of the license into the register of issued, registered, suspended and canceled licenses;

Registration may be refused in the manner and on the grounds provided for in paragraph 9 of this provision.

13. Upon liquidation of a legal entity, termination of the certificate of state registration of an individual as an entrepreneur, the license loses its legal force.

In the event of reorganization, change in the name of a legal entity, change in the passport data of an individual, loss of a license, the licensee is obliged to submit an application for renewal of the license within 15 days.

Reissuance of a license is carried out in the manner prescribed for its receipt.

Until the license is reissued, the licensee operates on the basis of a previously issued license, in case of loss of a license - on the basis of a temporary permit issued by the licensing authority.

14. Consideration of an application for a license and the issuance of a license are carried out on a fee basis. A fee equal to one tenth of the statutory minimum wage is charged for processing the application.

The fee for issuing a license is 3 times the statutory minimum wage.

In the case of additional, including independent, examination, the costs associated with the remuneration of experts, as well as other additional costs directly related to its conduct, are not included in the fixed license fee and are paid separately.

The fee for consideration of the application and the fee for the issuance of a license go to the budget, at the expense of which the relevant licensing authority is supported:

Licenses are issued for standard form, approved by the Ministry of Economy of the Russian Federation, have a degree of security at the level security bearer, are a document of strict accountability, have an accounting series and number. Acquisition, registration and storage of license forms are assigned to the licensing authorities.

16. The licensing authority suspends the license or cancels it in the following cases:

submission by the license holder of the relevant application; detection of inaccurate data in the documents submitted for obtaining a license;

violation by the licensee of the terms of the license; non-fulfillment by the licensee of instructions or orders of state bodies or suspension by them of the activities of a legal entity, as well as an individual engaged in entrepreneurial activities without forming a legal entity, in accordance with the legislation of the Russian Federation;

liquidation of a legal entity or termination of a certificate of state registration of an individual as an entrepreneur.

The licensing authority within 3 days from the date of the decision to suspend the license or to cancel it in writing informs the licensee and the bodies of the State Tax Service of the Russian Federation about this decision.

17. The executive authorities of the subjects of the Russian Federation shall suspend the validity of licenses on their territory issued by the executive authorities of other subjects of the Russian Federation, also in cases where: - the license is not registered in the given territory; the licensee does not comply with the requirements established in accordance with the legislation of the Russian Federation for the implementation of the relevant type of activity in this territory.

The executive authorities of the constituent entities of the Russian Federation, within 3 days from the date of the decision to suspend the license, inform the licensee, the executive authority of the constituent entity of the Russian Federation that issued the license, and the authorities of the State Tax Service of the Russian Federation about this decision in writing. In this case, the authority that issued the license decides to cancel it.

The license may be renewed in the event of a change in the circumstances that led to the suspension of the license.

The license is considered to be renewed after the adoption by the licensing authority of the relevant decision, of which it notifies the licensee and the authorities of the State Tax Service of the Russian Federation no later than 3 days from the date of adoption.

Suspension of the license may also be carried out by other bodies to which this right is granted by the legislation of the Russian Federation.

Control over compliance with the conditions stipulated by the license is carried out by the licensing body and state veterinary supervision bodies.

The licensing authority maintains a register of issued, registered, suspended and canceled licenses.

The heads and officials of the licensing bodies shall be liable in accordance with the legislation of the Russian Federation for violation or improper execution of this provision.

Decisions and actions of the licensing authorities may be appealed in the prescribed manner to the judicial authorities.

Currently in Russia licensing of veterinary activities is not carried out. If you decide to treat animals, then you can safely open a veterinary clinic, but you need to know and take into account:

  • only specialists with specialized education (higher or secondary specialized) can treat animals;
  • must be registered with the regional veterinary authority;
  • there are certain requirements for equipment and premises.

If the veterinary clinic plans sale, storage, transportation, manufacture, dispensing of drugs for veterinary use(actually opening veterinary pharmacy), you will need an appropriate license. It is about obtaining such a license that will be discussed in the article.

So, if you decide to trade in flea collars, shampoos for four-legged friends, tablets for worms - get a government permit. Bodies that do this:

  • Federal Service for Veterinary and Phytosanitary Supervision (Rosselkhoznadzor)
  • Regional branches of Rosselkhoznadzor

Reference! Start obtaining a license to open a veterinary pharmacy with a visit to the Resselkhoznadzor. In the Licensing Department you will find all comprehensive information.

Licensing is carried out on the basis of:

  • Federal Law of 04.05.2011 No. 99-FZ “On Licensing Certain Types of Activities”;
  • Decree of the Government of December 22, 2011 No. 1081 "On licensing pharmaceutical activities" .

Even the most scrupulous Internet site will not be able to give a complete answer about all the documents for the licensing authority. Legislation is constantly being tightened and supplemented. But here's what is typical, the terms of service provision remain unchanged. Still after 30 - 45 days you will have a permit that is valid indefinitely.

  • the veterinary pharmacy must have premises equipped in accordance with the requirements (trading floor, warehouse);
  • walls, partitions, ceilings must be smooth and accessible for wet cleaning;
  • premises should be controlled by temperature and humidity characteristics in accordance with the conditions for storing medicines;
  • must be good lighting– natural or artificial origin;
  • availability of natural or forced ventilation, heating and power supply systems.
  • for the export of solid household waste;
  • for the disposal of biological and medical waste;
  • for preventive disinfection, disinsection, deratization of premises.

It is also necessary to have logs:

  • inspections by regulatory organizations;
  • measurements of temperature and humidity in the premises (separately - for the temperature in the refrigerator);
  • cleaning and disinfection of premises.

Attention! Cleanliness is an important factor in regulatory inspections. Otherwise, penalties are possible.

Documentation

The applicant submits to the relevant licensing authority:

  • personal statement;
  • charter;
  • legal and postal address;
  • type of veterinary activity;
  • copies of identity documents;
  • TIN, certificate from the tax authority, registration number- OGRN;
  • a copy of the contract confirming the ownership or lease of the premises;
  • contracts for the maintenance of equipment and premises by specialized firms;
  • the conclusion of the SES on the premises;
  • copies of diplomas of veterinary or pharmaceutical education manager and all employees;
  • confirmation of work experience in this field, certificates, certificates;
  • receipt of payment of state duty (7500 rubles);
  • description of submitted documents.

You can find out about the documents required when applying in the article at the link.

How to get a permit to sell vet. drugs: algorithm

When obtaining a license on your own, you must study the Administrative Regulations approved by the Order of the Ministry of Agriculture of Russia dated 01.03. 2016 No. 80, in which the entire procedure is described in detail.

Having collected the full package of necessary documents, it is time to transfer them to the licensing authority using:

  • courier;
  • Russian Post;
  • an email with an enhanced qualified electronic signature;
  • personal presence in the licensing department.

Reference! Currently, there are a number of law firms on the services market that will gladly save you from the tedious collection of the necessary documents and endless trips to authorities for payment.

Any option is acceptable. The specialist receiving the package will point out the shortcomings, if any. Within 30 to 45 days you will receive a perpetual license.

Receipt may be refused if obvious inaccuracies or falsifications of information about the licensee are revealed within the time limits allotted by law for verification.

Re-registration

The license is subject to renewal in the following cases:

  • change in the owner's passport data;
  • natural abrasion of the letterhead;
  • changes in the details of the company in connection with the reorganization;
  • change of location;
  • change in the list of works, services;
  • detection of inaccuracies in records, etc.

Depending on the specific case, the list of required documents, as well as the state duty for reissuance, will vary.

For example, when reissuing a document related to changes in addresses, types of work of a licensed type of activity, the state duty will be 3500 rub., and the due date is 30 days.

You can find out about the re-registration in the article at the link.

Suspension and termination

The document may be revoked if it turns out that it:

  • an outsider works;
  • gross violations of the law have been identified;
  • personal statement of the owner, in connection with the termination of activities;
  • failure to comply with the instructions and orders of state supervisory services;
  • the license was issued in another subject of the federation and has not been registered in this territory.

If you have accidentally lost permits, contact Rosselkhoznadzor immediately. You are required to issue a duplicate, as well as record the loss of the original. True, you will have to pay a state duty for issuing a duplicate - 750 rub.

Work without permission

Such work is evaluated by supervisory authorities as gross violation legislation of the Russian Federation. There may be the following consequences:

  • liquidation of legal faces;
  • administrative punishment of the owner of the company or individual entrepreneur;
  • criminal liability.

If the service rendered without proper registration has brought tangible losses to the owners of the animals, the decision is made at the court session. This can be a hefty fine, damages, or a jail sentence.

In general, obtaining a license for veterinary activities has its own characteristics. Having studied the recommended regulatory documentation, you can independently and at no extra cost to issue a permit.

If you wondered if you need a license to open a veterinary clinic, then in this article we will try to fully answer your question.

Licensing of veterinary care

Obtaining a license for this type of activity is not provided for by the Law of the Russian Federation. Since 01.01.07 the need for licensing has been abolished.

But, if an IP is registered, then:

  1. to provide veterinary assistance are entitled to specialists with higher or secondary specialized education;
  2. a person planning to engage in specialized care for animals must register with the regional veterinary authority belonging to the branch of executive power of the Russian Federation. Such a need is regulated by the Law of the Russian Federation of May 14, 1993 N 4979-I "On Veterinary Medicine" (as amended and supplemented) Art. No. 4;
  3. an individual entrepreneur or clinic is allowed to purchase and store medicines for assistance on the territory of the clinic / office.

When Licensing Is Still Necessary

If the owner of the clinic plans to engage in:

  • trade in veterinary preparations;
  • realization in wholesale quantities, transportation and storage of medicines;
  • trade in accessories for animals (anti-flea collars, etc.);

Features of the process of obtaining a license

Activities in the field of pharmaceutical products are licensed by the Rosselkhoznadzor. Accordingly, it is necessary to apply to the local representative office of this body with an application and a package of documents required by law. Regulates licensing in this area "Regulations on Licensing Pharmaceutical Activities" in red. Decrees of the Government of the Russian Federation of 04.09.2012 N 882, of 15.04.2013 N 342.

What you need to do before contacting the Rosselkhoznadzor

As in the case of medical practice, licensing is carried out after:

  • registration of an organization or individual entrepreneur;
  • lease / purchase of premises, repair work;
  • obtaining permits from the services of sanitary and epidemiological supervision;
  • recruitment (in the case of an LLC);
  • conclusion of all necessary contracts.

Obtaining a license is the final step in preparing to open a veterinary practice. In order to obtain a license for such activities, you must have the appropriate qualification documents and work experience of at least 3 years. The license in this area is issued for a period of 5 years. If the business owner does not have a veterinary diploma, he can enter into a contract with a specialist who has Required documents and experience.

They are sent to the licensing organization (by mail, by registered mail or personally) copies of documents. Organizations certify their documents with the seal of the company and the signature of its director. Documents are considered for about 45 days.

What do you need to pass the licensing commission?

During the period of consideration of documents, a commission from the relevant body is sent to inspect the premises. Only premises intended for the storage and sale of veterinary drugs will be inspected. The requirements for such a room that must be met are as follows:

  • repair work has been completed;
  • Premises intended for the storage of medications must be appropriately equipped and have devices for determining the parameters of the microclimate (temperature and humidity conditions). The number of metering devices should correspond to the number of rooms.

For veterinary pharmacies and outlets in the clinic, the requirements are wider. In addition to the completed repair, the room must have the appropriate equipment:

  1. The trading floor should have ready-to-work showcases, installed shelving complexes and cabinets with drawers. A refrigerator is required for vaccines and other medicines requiring special conditions storage.
  2. Shelves of commercial equipment, including refrigerators, must be marked.
  3. Both in warehouses and trading floors there should be devices that determine the temperature and humidity indicators of the microclimate (hygrometer, thermometer). Level gauge relative humidity(hygrometer) is checked every 2 years. This must be recorded in his passport. This device is placed in relation to the door no closer than 3 m, and 1.5-1.7 m from the floor level.
  4. An auxiliary room ("utility room") should have a closet or cabinet for storing disinfectants and cleaning equipment. Shelves in this cabinet/cabinet and inventory are marked (the cleaning room for which it is intended is indicated).
  5. The premises of the veterinary pharmacy must be equipped with a table for receiving goods.
  6. The warehouse should provide a place for storing drugs with an expired shelf life. It is located separately from the racks with goods corresponding to the expiration date. It is clearly marked.

At the time of the audit, the following logs must be issued:

  • Accounting checks.
  • Cleaning and disinfection.
  • Temperature and humidity conditions.

If there are several rooms, magazines are started for each. After checking, the commission draws up an act, a copy of which is received by the owner of the clinic. If the commission has not found reasons for refusal, the licensee receives the coveted document.