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How to sell veterinary drugs without a license. What is the fine for individual entrepreneurs for selling veterinary drugs without a license?

Currently in Russia licensing of veterinary activities is not carried out. If you decide to treat animals, 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;
  • it is necessary to register with the regional veterinary authority;
  • there are certain requirements for equipment and premises.

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

So, if you decide to sell flea collars, shampoos for four-legged friends, and deworming tablets, get government permission. Bodies that deal with this:

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

Reference! Start obtaining a license to open a veterinary pharmacy by visiting the Resselkhoznadzor. You will find all the comprehensive information in the licensing department.

Licensing is carried out on the basis of:

  • Federal Law dated May 4, 2011 No. 99-FZ “On licensing of certain types of activities”;
  • Government Decree No. 1081 dated December 22, 2011 “On licensing of 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 what is characteristic is that the terms for providing the service remain unchanged. Still, in 30 - 45 days you will have a permit that is valid indefinitely.

  • the veterinary pharmacy must have premises equipped in accordance with the requirements (sales area, warehouse);
  • walls, partitions, ceilings must be smooth and accessible for wet cleaning;
  • premises must be controlled according to temperature and humidity characteristics in accordance with the storage conditions of medicines;
  • must be good lighting– natural or artificial origin;
  • the presence of natural or forced ventilation, heating and power supply systems.
  • for the removal of solid waste;
  • for the disposal of biological and medical waste;
  • for preventive disinfection, disinsection, and deratization of premises.

You also need to keep logs:

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

Attention! Cleanliness is an important factor when conducting inspections by regulatory authorities. Otherwise, penalties may apply.

Documents

The applicant submits to the relevant licensing authority:

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

You can find out about the documents required for this in the article at the link.

How to obtain permission to sell veterinary 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, which describes the entire procedure in detail.

Having collected the full package of necessary documents, the moment comes 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 service market that will be happy to relieve you of the tedious collection of necessary documents and endless trips to authorities for payment.

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

Receipt may be refused if, within the time period allotted by law for verification, obvious inaccuracies or falsification of information data about the licensee are revealed.

Re-registration

The license is subject to renewal in the following cases:

  • changing the owner’s passport data;
  • natural abrasion of the stamp form;
  • changes in company details due to reorganization;
  • change of location;
  • changing the list of works and services;
  • detecting inaccuracies in records, etc.

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

For example, when re-issuing 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 deadline is 30 days.

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

Suspension and termination

A document may be revoked if it turns out that:

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

If you accidentally lost your permits, contact Rosselkhoznadzor immediately. You are required to issue a duplicate and also document the loss of the original. True, you will have to pay a state fee for issuing a duplicate - 750 rub..

Work without permission

Such work is assessed by supervisory authorities as a gross violation of the law. Russian Federation. The following consequences may occur:

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

If the service provided without proper registration has brought significant losses to the animal owners, the decision is made in a court hearing. This could be a substantial fine, damages, or a prison sentence.

In general, obtaining a license for veterinary activities has its own characteristics. After studying the recommended regulatory documentation, you can apply for a permit yourself and at no extra cost.

Where are licenses for veterinary pharmaceutical activities obtained?

A veterinary license is issued, renewed, and also regulated by the authority government structure, which is called Rosselkhoznadzor.

Receiving stages

Get veterinary license It is possible, however, you have to go through a number of tests and checks. Don’t forget about collecting documents and properly preparing them, which can take a lot of time. And to ensure that you get the desired result, you just need to give us the opportunity to help you, and our specialists will go through all stages of preparation (they will carefully study the situation, provide advice and recommendations, and plunge headlong into the process):

  1. An internal compliance review will be conducted initially. Our specialists will check your readiness for further completion of the stages.
  2. Then they will help you pass the necessary checks from regulatory authorities and receive a positive conclusion.
  3. In the future, a pack of documents will be collected.
  4. Support of documents to government agencies will begin.
  5. All that remains is to pick up the document and give it to you.

As you can see, there are few steps, but don't underestimate them. Each of them has a lot of nuances and requires certain knowledge and actions. Therefore, if you are thinking about how to obtain a veterinary license for a pet store, but are confused in the steps and are sure that you will not be able to perfectly fulfill all the requirements, then our company will help you achieve a positive result. All you have to do is contact us, draw up an agreement and further process will already be assigned to our specialists. All you need is support and provision of documents, we will do the rest for you.

Receipt times

The period required for receipt is 30-45 days (working days) from the moment the documents are submitted to specialized government agencies.

Term careful preparation documents for further licensing can vary from 3 to 15 calendar days.

Difficulty obtaining

As for the difficulties in obtaining a license for a veterinary pharmacy, they are expressed exclusively by requirements that must be complied with:

  1. Have a lease agreement or certificate of ownership of the premises.
  2. There must be a document giving the right to carry out medical activities.
  3. Having specialized experience related to the specified activity. It must be at least 3 years old, as well as a document confirming higher education in this direction.
  4. Availability of specialized documents (they must confirm their professional awareness, knowledge and experience) for workers who directly work with pharmaceuticals.

It is worth noting that all these requirements are given exclusively for the surface and may change in accordance with the main focus. For example, there are differences in terms of employment, for example, if a person is engaged in wholesale distribution, certain requirements are imposed on him, in the case of production, other requirements already appear, and the requirements in the direction of trade also differ. It is worth understanding that veterinary pharmaceutical activity can be versatile and each case will necessarily have its own characteristics. Therefore, sometimes it is not so easy to obtain a license to trade veterinary drugs, not to mention other related areas. But if you contact us, then all problems will be solved and tests will be passed. We have extensive experience in this field and are ready for any difficulties.

Sale of veterinary drugs is a licensed activity

REGULATIONS ON LICENSING PHARMACEUTICAL ACTIVITIES

This Regulation establishes the licensing procedure pharmaceutical activities carried out by legal entities, including organizations wholesale trade medicines, pharmacy organizations, veterinary pharmacy organizations,

FEDERAL LAW
ABOUT LICENSING SPECIFIC TYPES OF ACTIVITY

Article 12. List of activities for which licenses are required

47) pharmaceutical activities;

Article 14.4.2. Violation of legislation on the circulation of medicines
(introduced Federal law dated November 25, 2013 N 317-FZ)

1. Violation of established rules for wholesale trade in medicines and procedures retail medicines- entails imposition administrative fine for citizens in the amount of one and a half thousand to three thousand rubles; for officials - from five thousand to ten thousand rubles; on legal entities- from twenty thousand to thirty thousand rubles.

Article 14.1. Carrying out business activities without state registration or without special permission (license)

2. Carrying out business activities without a special permit (license), if such a permit (such license) is mandatory (mandatory), - entails the imposition of an administrative fine on citizens in the amount of two thousand to two thousand five hundred rubles with confiscation of manufactured products, production tools and raw materials. or without it; for officials - from four thousand to five thousand rubles with or without confiscation of manufactured products, production tools and raw materials; for legal entities - from forty thousand to fifty thousand rubles with or without confiscation of manufactured products, production tools and raw materials.
3. Carrying out business activities in violation of the conditions provided for by a special permit (license) - entails a warning or the imposition of an administrative fine on citizens in the amount of one thousand five hundred to two thousand rubles; for officials - from three thousand to four thousand rubles; for legal entities - from thirty thousand to forty thousand rubles.
(as amended by Federal Laws dated June 22, 2007 N 116-FZ, dated July 27, 2010 N 239-FZ)
4. Carrying out business activities in gross violation of the conditions provided for by a special permit (license) - entails the imposition of an administrative fine on persons carrying out entrepreneurial activity without forming a legal entity, in the amount of four thousand to five thousand rubles or administrative suspension of activities for up to ninety days; for officials - from four thousand to five thousand rubles; for legal entities - from forty thousand to fifty thousand rubles or administrative suspension of activities for a period of up to ninety days.
(as amended by Federal Law dated June 22, 2007 N 116-FZ)
(Part four introduced by Federal Law dated July 2, 2005 N 80-FZ)
Note. Lost power. - Federal Law dated 06/08/2015 N 140-FZ.
Notes:
1. Concept gross violation is established by the Government of the Russian Federation in relation to a specific licensed type of activity.
2. A person is released from administrative liability if it is revealed that he has committed actions (inaction) containing signs of criminal offenses administrative offense provided for by this article or articles 15.1, 15.3 - 15.6, 15.11, 15.25 of this Code, provided that this person is a declarant or a person whose information is contained in a special declaration filed in accordance with the Federal Law “On Voluntary Declaration” individuals assets and accounts (deposits) in banks and on amendments to certain legislative acts of the Russian Federation,” and if such actions (inaction) are related to the acquisition (formation of sources of acquisition), use or disposal of property and (or) controlled foreign companies and (or) with the performance of currency transactions and (or) crediting cash to accounts (deposits), information about which is contained in a special declaration.

I would classify your actions under 2 articles:

1. 14.1. - object of relationship - license

2. 14.4.2. - object of drug relations without a license