In Russia, any activity related to human health and safety is subject to licensing. So, the sale and manufacture of medicines is possible only after obtaining special permission. Licensing of pharmaceutical activities is one of the most important components of security. After all, many drugs are classified as especially dangerous or narcotic. Such drugs require special storage conditions, control and strict accounting. If a company selling such products does not have a license to carry out pharmaceutical activities, no one can guarantee that the rules are being followed. This can lead to irreparable consequences.
What is subject to licensing
Licensing of pharmaceutical activities is mandatory for each of the following types of business:
- the manufacture of medicines for both people and in the field of veterinary medicine;
- storage and transportation of medicines;
- retail sale of medicines, sales through pharmacies;
- Wholesale of medicines, dietary supplements, other goods dispensed in pharmacies.
Types of pharmacies
If we talk about fundamental differences, the licensing of pharmaceutical activities can be divided into two large groups.
- The first is retail. Includes the release of medical supplies through pharmacies, shops and kiosks of a special orientation.
- The second is the wholesale of pharmaceuticals. This refers to a pharmacy warehouse.
Pharmacies themselves can also be divided into several types. The order of the Ministry of Health and Social Development, for example, highlights the following:
Pharmacy. This is a generic name. In fact, these institutions can be divided into two types:
- production - with the function of manufacturing medicines and aseptic drugs;
- realizing only ready-made medications.
Pharmacy stall, kiosk or store. This is a unit that has the right to sell only those drugs for which a doctor’s prescription is not required. You can also sell dietary supplements and personal care products.
Pharmacy. It is also a pharmacy unit, which is most often created at medical or sanatorium institutions.
Pharmacy warehouse. A larger institution that provides small pharmacies with pharmaceuticals on a wholesale basis.
All of them differ from each other in the number and quality of functions prescribed in the industry standard. The least right, of course, is the stall, and most of all - the state pharmacy. If you decide to engage in the pharmaceutical business, it is best to get permission to open a pharmacy. After that, if necessary, you can open additional kiosks or points. It will not be difficult to do this, because they will structural units main pharmacy, not an independent entity.
How to open a pharmacy
Opening a pharmacy is not very difficult, but rather troublesome. For each option, whether it is a point, a pharmacy or a kiosk, there are requirements for the size of the room, sanitary standards and the number of employees. Well, of course, you will need a pharmaceutical license. To get it, you need to fulfill some conditions and collect a full package of documents, which we will talk about below.As already mentioned, smaller structural units are part of the main pharmacy, and it is not necessary to obtain a work permit for each of them. All of them can work under the license issued by the main enterprise.
Terms and conditions for obtaining a pharmaceutical license
A pharmacy license is issued in accordance with the following regulatory framework:
- Federal Law No. 323 of November 21, 2011 "On the basics of protecting the health of citizens in the Russian Federation."
- “On licensing of pharmaceutical activities” - Decree of the Government of the Russian Federation No. 1081 of December 22, 2011.
- Federal Law No. 99 of May 4, 2011 - "On licensing of certain types of activities."
These documents establish a list of conditions for obtaining permission:
- the possession, lease or sublease of a trading or warehouse premise of sufficient area;
- when a medical organization claims for permission, it is additionally necessary to provide a license for the right to conduct medical activities;
- the presence of the head of higher medical education;
- at least 3 years of work experience in the medical field is required;
- if there is no higher education, then the work experience is increased to 5 years;
- a certificate of advanced training is also required;
- all employees working in a pharmacy are also required to have a medical education as a pharmacist or pharmacist; this fact must be confirmed by a diploma and a qualification certificate;
- the same requirements apply to applicants for a license in veterinary medicine.
What a license consists of
A pharmacy license, like any other government document, has a clear structure. It must contain the following items:
- name of the authority issuing the document;
- OKPO code;
- legal address of the owner of the enterprise;
- the full name of the subject who received the permit;
- form of its legal activity;
- registration number of the permit and its validity;
- the types of activities permitted on the basis of this document to a specific subject of licensing;
- Date of registration of the document in the federal registry.
Documents
To obtain a permit, whether it is a state pharmacy, a kiosk, a warehouse or something else, you need to collect a whole package of documents. Here is a sample list of them:
- application for pharmaceutical license;
- certificate of OGRN, statistics codes;
- statutory documents, including all likely changes;
- TIN;
- receipt of state duty;
- extract from the register;
- documents for all employees, including information on work experience and education;
- lease agreement or certificate of ownership of the premises in which the pharmacy is planned to open;
- floor plan of the building, certified by the seal of the BTI;
- documents for the right to use equipment;
- explication;
- conclusion of organs fire supervision and other supervisory authorities.
All these documents must be certified by a notary. You also need to prepare a written description of the licensed item and a list of employees. These documents must be certified with the seal of the organization.
Also, to open a pharmacy, you will additionally need a sanitary and epidemiological conclusion of Rospotrebnadzor. To draw it up, you also need to collect a lot of documents:
- conclusion of the district sanitary-epidemiological service;
- contract for disinfection and garbage collection;
- medical books of employees with notes on passing the medical examination on time;
- contract for washing clothes (if necessary);
- contract for the disposal of fluorescent lamps;
- light measurements;
- microclimate indicators;
- production control plan;
- floor plan of ventilation;
- other documents.
Where to go
When the package of documents is completely ready, you need to apply for permission. Licensing of pharmaceutical activities is carried out by the Federal Service for Supervision of Health and Social Development. The document received at this organization is valid throughout Russia.
If you need to obtain a license that is valid only on the territory of a city, documents must be submitted to the Department of Health. For the region - the Ministry of Health.
How much to wait and who will be refused
Not later than 45 days after the filing of the documents, the applicant must be issued a license or a reasoned refusal must be issued. There can be several reasons for refusal:
- documents submitted for consideration contain errors or inaccuracies;
- the object for which the license is issued does not meet the established requirements.
In any case, you will receive a written document indicating specific errors.
Cost and validity period of a document
Since 2011, the validity period of the pharmaceutical license has been canceled. Now it is issued once and acts indefinitely. However, if additions or changes are required to an already issued document, the procedure will have to be repeated.
You will have to renew your existing license in such cases:
- legal entity reorganization;
- commencement of business at an address not specified in the current license;
- change of surname, name, patronymic of the head (IP), as well as details of his documents;
- carrying out work or providing services not specified in an existing document.
The cost of obtaining a license will depend on who exactly will draw up all the documents. If you decide to do this on your own, you will have to pay a state fee in the amount of 7 thousand 500 rubles, and, perhaps, some more amounts for certain certificates. But there is another way. You can ask for help in a legal office, which is engaged in the preparation of such documents. The cost of their services usually starts at 60 thousand rubles, but you will have to run much less.
What threatens work without a license
As you already understood, licensing of pharmaceutical activities is a very important component of the drug business. Nevertheless, sometimes entrepreneurs neglect to obtain permission and conduct their activities without proper paperwork. Various measures of liability are provided for them, provided for in Article 14.1 of the Code on Administrative Offenses of the Russian Federation:
- for citizens - a fine from 2 to 2.5 rubles, the confiscation of raw materials, implements and production itself is also likely;
- for legal entities - a fine in the amount of from 4 to 5 thousand rubles, with confiscation of all of the above or without it;
- for officials - a fine of 40 to 50 thousand rubles with or without confiscation.
In addition, specialists with a pharmaceutical education are required to take advanced training courses with a frequency of at least 1 time in 5 years. Failure to comply with this requirement also entails a fine on the head of the enterprise.
Conclusion
As you can see, obtaining a pharmaceutical license is not so much complicated as it is long and troublesome. Therefore, if you are not confident in your abilities, but you are determined to achieve your goal, it is worth considering the issue of contacting specialists. This will help to avoid many errors, inaccuracies and corrections and significantly speed up the time. After all, you probably will not have to redo it. Firms with experience in this matter will help you get a license the first time. True, it will cost much more. You decide.
