The procedure for obtaining a license to engage in pharmaceutical activities. Pharmacy licensing procedure: requirements and deadlines

On the territory of Russia, any activity related to human health and safety is subject to licensing. Thus, the sale and manufacture of medicines is possible only after obtaining a special permit. Licensing of pharmaceutical activities is one of the most important components of safety. After all, many drugs belong to the category of especially dangerous or narcotic drugs. Such medicines require special storage conditions, control and strict accounting. If the 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:

production of medicines for both humans and veterinary medicine;
storage and transportation of medicines;
retail sale of medicines, sales through pharmacies;
wholesale trade in medicines, dietary supplements, and other goods sold in pharmacies.

Types of pharmacies

If we talk about fundamental differences, licensing of pharmaceutical activities can be divided into two large groups.

The first is retail trade. Includes the dispensing of medical supplies through pharmacies, shops and specialty kiosks.
The second is the wholesale sale 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, identifies the following:

Pharmacy. This is a common name. In fact, these institutions can be divided into two more types:

production - with the function of manufacturing medicines and aseptic preparations;
selling only finished medications.

Pharmacy stall, kiosk or store. This is a division that has the right to sell only those drugs that do not require a doctor’s prescription. You can also sell dietary supplements and personal hygiene products here.

Pharmacy. It is also a division of a pharmacy, which is most often created at medical or sanatorium institutions.

Pharmacy warehouse. A larger institution that supplies small pharmacies with medications on a wholesale basis.

They all differ from each other in the quantity and quality of functions specified in the industry standard. Of course, the stall has the least rights, and the state pharmacy has the most rights. If you decide to engage in the pharmaceutical business, it is best to obtain permission to open a pharmacy. After this, you can open additional kiosks or points if necessary. This will not be difficult to do, because they will be structural divisions of the main pharmacy, and not an independent entity.

How to open a pharmacy

Opening a pharmacy is not very difficult, but quite troublesome. For each option, be it a point, pharmacy or kiosk, there are requirements for the size of the premises, sanitary standards and the number of employees. And, of course, you will need a pharmaceutical license. To receive it, you need to fulfill some conditions and collect a complete package of documents, which we will talk about below. As already mentioned, smaller structural units are part of the main pharmacy, and there is no need to obtain permission to operate each of them. All of them can operate under a license issued to the main enterprise.

Requirements 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:

availability of ownership, lease or sublease of retail or warehouse space of sufficient space;
when a medical organization applies for permission, it is additionally necessary to provide a license to conduct medical activities;
the manager has higher medical education;
At least 3 years of work experience in the medical field is also required;
if there is no higher education, then the work experience increases 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 qualification certificate;
the same requirements apply to applicants for a license in veterinary medicine.

What does a license consist of?

A pharmacy license, like any other state document, has a clear structure. It must contain the following items:

name of the authority that issued the document;
OKPO code;
legal address of the owner of the enterprise;
full name of the entity that received the permit;
the form of its organizational and legal activities;
registration number of the permit and its validity period;
types of activities permitted on the basis of this document for a specific licensing subject;
date of registration of the document in the federal register.

Documentation

To obtain a permit, be it for a state pharmacy, kiosk, warehouse or anything else, you need to collect a whole package of documents. Here is a sample list of them:

application for a pharmaceutical license;
OGRN certificate, statistics codes;
statutory documents, including all possible changes;
receipt of payment of state duty;
extract from the Unified State Register of Legal Entities;
documents for all employees, including information about work experience and education;
a lease agreement or certificate of ownership of the premises in which it is planned to open a pharmacy;
floor plan of the building, certified by the BTI seal;
documents for the right to use the equipment;
explication;
conclusion of fire inspection authorities and other supervisory authorities.

All these documents must be certified by a notary. You also need to prepare a written description of the licensing object and a list of employees. These documents must be certified with the organization's seal.

Also, to open a pharmacy, you will additionally need a sanitary and epidemiological certificate from Rospotrebnadzor. To complete it, you also need to collect a lot of documents:

conclusion of the district sanitary and epidemiological service;
contract for disinfection and waste removal;
medical records of employees with notes on passing the medical examination in due time;
contract for washing clothes (if necessary);
agreement for the recycling of fluorescent lamps;
illumination measurements;
microclimate measurements;
production control plan;
ventilation floor plan;
other documents.

Where to contact

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 Surveillance in Healthcare and Social Development. The document received from this organization is valid throughout Russia.

If you need to obtain a license valid only in the territory of a city, the documents must be submitted to the Department of Health. For the region - Ministry of Health.

How long to wait and who will be refused?

No later than 45 days after submitting the documents, the applicant must be issued a license or given a reasoned refusal. There may 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 either case, you will receive a written document indicating the specific errors.

Cost and validity period of the document

Starting from 2011, the validity of the pharmaceutical license was canceled. Now it is issued once and is valid indefinitely. However, if additions or changes are required to an already issued document, the procedure will have to be completed again.

You will have to renew your existing license in the following cases:

reorganization of a legal entity;
starting to conduct business at an address not specified in the current license;
changing the last name, first name, patronymic of the manager (IP), as well as details of his documents;
carrying out work or providing services not specified in the 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 yourself, you will have to pay a state fee in the amount of 7 thousand 500 rubles, and, perhaps, some other amounts for certain certificates. But there is another way. You can seek help from a law office that deals with the preparation of such documents. The cost of their services usually starts from 60 thousand rubles, but you will have to run much less.

What are the risks of working without a license?

As you already understand, licensing of pharmaceutical activities is a very important component of the drug business. However, sometimes entrepreneurs neglect to obtain permission and conduct their activities without proper paperwork. They are subject to various penalties provided for in Article 14.1 of the Code of Administrative Offenses of the Russian Federation:

for citizens - a fine of 2 to 2.5 rubles, confiscation of raw materials, production tools and the products themselves is also likely;
for legal entities - a fine in the amount of 4 to 5 thousand rubles, with or without confiscation of all of the above;
for officials - a fine of 40 to 50 thousand rubles with or without confiscation.

In addition, specialists with a pharmaceutical education are required to undergo advanced training courses at least once every 5 years. Failure to comply with this requirement also entails the imposition of a fine on the head of the enterprise.

Conclusion

As you can see, obtaining a license for pharmaceutical activities is not so much a complicated matter as it is long and troublesome. Therefore, if you are not confident in your abilities, but are determined to achieve your goal, you should consider turning to specialists. This will help avoid many errors, inaccuracies and corrections and significantly speed up deadlines. After all, most likely you won’t have to redo it. Firms with experience in this matter will help you obtain a license the first time. True, it will cost much more. You decide.

Types of pharmacies and pharmacy points

At the moment, there are several types of retail outlets, which can be distinguished by several points (some of them are further divided into sub-points):

Pharmacy (a universal type of organization that can not only engage in retail trade, but also perform production functions):
1. They cannot engage in production.
2. They are engaged in production.
3. They are engaged in production and have the right to produce drugs without the introduction of microorganisms, etc. (aseptic drug).
Pharmacy points (there is no production in them, and the main activity is aimed strictly at retail trade).
Pharmacy kiosk (additional retail outlets for medicines, although the exception is the inability to distribute prescription drugs).
Pharmacy store.
Pharmacy online sales.

To obtain a pharmacy license you will have to try hard, as you will need to visit various authorities, conduct inspections, participate in the collection of documents and regulate various issues. Obtaining a license on your own can take a lot of time and effort.

Another option for obtaining a pharmacy license is to contact special law firms that provide comprehensive support and guarantee a positive result. True, you will have to pay for these services.

Administrative and criminal violations and fines

Carrying out work without the appropriate license threatens YOU with administrative liability up to and including the closure of the enterprise.

As for fines, they are issued in case of carrying out activities with a license, but with some violations (failure to comply with inspection requirements):

Officials: up to 10 thousand rubles.
Entrepreneurs: up to 8 thousand rubles. (closing up to 3 months).
Legal persons: up to 200 thousand rubles (closing up to 3 months).

Pharmacy equipment

To equip a pharmacy, the following must be used:

Furniture for a pharmacy that meets all necessary requirements and is used not only for comfort, but also for specialized storage of medicines.
Equipment for production (with all certificates and other documents of conformity).

Now you have all the necessary information regarding obtaining a pharmacy license. All that remains is to draw up a plan for meeting the requirements, choose a method for obtaining a license and try to achieve a positive result. And our article will become the basis in terms of information.

Any activity on the territory of the Russian Federation that is related to human health and well-being is subject to a mandatory licensing procedure in accordance with the law. Therefore, the sale of pharmaceuticals and drugs is possible only after obtaining a license for the right to such trade, because some drugs can be classified as particularly dangerous, requiring special control and accounting, as well as the right to be sold strictly according to a prescription.

Also, some drugs require special storage and transportation conditions, because if these basic rules are not followed, the therapeutic effect may be lost, and sometimes the drug can even cause severe harm.

Activities subject to licensing

So, if you carry out the following types of activities, then obtaining a permit is mandatory:

retail. Includes single dispensing of goods, medicines, sales through pharmacies;
wholesale trade in dietary supplements, goods, medicines that are allowed to be sold through pharmacies;
transportation and storage of medicines;
their production and manufacturing;
These are the same types of activities used in veterinary medicine.

By type, pharmaceutical licenses are divided into two types:

For wholesale trade in pharmaceuticals (pharmacy warehouses).
For retail sale of medical drugs, that is, dispensing from pharmacies, kiosks, shops.

Primary requirements

To obtain a license in accordance with Decree of the Government of the Russian Federation No. 1081 dated December 22, 2011. “On licensing of pharmaceutical activities”, Federal Law No. 323-FZ 11/21/2011. “On the fundamentals of protecting the health of citizens in the Russian Federation”, Federal Law No. 99-FZ dated 05/04/2011. “On licensing of certain types of activities” establishes quite stringent conditions and requirements:

The applicant must have retail (warehouse) premises owned or leased (subleased).
If the applicant is a medical organization, then a license to provide medical services is required.
For heads of organizations, a higher education in a medical field is required. A minimum of three years of work experience in a medical specialty is required. A certificate of professional development of a specialist is required. If the manager does not have a higher education, then the work experience in a similar position must be at least five years. A certificate is also required. The same requirements apply to applicants for obtaining permission to carry out activities in veterinary medicine.
Employees of the enterprise must have a higher or secondary medical education, which in turn must be confirmed by copies of diplomas. Certificates are also required.
The same requirements apply to individual entrepreneurs.

Required documents

To obtain permission, you need to collect a whole package of documents, namely:

OGRN certificate, as well as all statutory documents and documents relating to all changes, including protocols (decision on creation), statistics codes, TIN certificate. The specified documents are provided certified by a notary.
, notarized.
State fee for consideration of an application for a license.
Conclusion of the Sanitary and Epidemiological Station, notarized.
Copies of documents for employees, notarized.
Lease agreement for the premises with an acceptance certificate, certified by a notary, with a floor plan, explications, certified by the seal of the BTI authorities.
Conclusion of fire inspection authorities, notarized.
Characteristics of the licensing object, list of employees, certified by the seal of the organization.

License issuing authority

These documents are submitted to Federal Service for Surveillance in Healthcare and Social Development. The license obtained from this organization is valid throughout the entire Russian Federation.

If you need a permit valid in the territory of Moscow, then the documents must be submitted to the Moscow Department of Health. On the territory of the Moscow region - the Ministry of Health of the Moscow region.

Deadline for reviewing documents and grounds for refusal

During 45 days from the moment the package of documents is received for consideration by the licensing authority, it is obliged to issue a license or a reasoned refusal to issue it.

They may refuse in the following cases:

The submitted documents contain errors or distortions.
The objects for which a permit is obtained do not meet the mandatory requirements.

Notifications of refusal are sent to the applicant in writing with a mandatory indication of unmet requirements.

Validity and cost

Since 2011 pharmaceutical license issued for an unlimited period, that is, now it is indefinite. However, if you make any changes to the information about a legal entity, you will also have to contact the licensing authority to re-issue the document.

You can learn more about re-issuing a permit from the following video:

In accordance with the Tax Code of the Russian Federation, the state duty is 7,500 rubles.

Summarize. Activities aimed at storage, transportation, production of medicines and drugs, as well as their sale, are under special control of the state, and therefore require licensing. After all, first of all, such drugs are necessary for the normal life support of the health and well-being of the population as a whole.

The list of documents for obtaining a permit and requirements are quite extensive and require a special and comprehensive approach.

Therefore, in order to avoid errors, corrections, and inaccuracies, it is recommended to contact specialized organizations for the preparation of such documents and support of such transactions.

A list of requirements and conditions, upon fulfillment of which a pharmacy is allowed to carry out pharmaceutical activities (a license is issued by the Federal Service for Surveillance in Healthcare and Social Development).

1. Availability of Constituent documents (Charter, minutes of the constituent meeting on the election of the General Director);
2. Certificate of state registration of the enterprise;
3. Certificate of tax registration;
4. Documents confirming the right to use the premises (certificate of ownership of the premises, or a lease agreement confirming the right of ownership of the owner of the premises)
5. Plan and explication of the premises issued by the Federal State Unitary Enterprise "Rostekhinventarizatsiya";
6. Sanitary and epidemiological report;
7. Conclusion of the state fire service on compliance of the license applicant’s facility with fire safety requirements;
8. The entrance (exit) is equipped for visiting people with impaired musculoskeletal system functions;
9. The premises are functionally combined into a single block;
10. A sign indicating ownership, operating hours, telephone number of the enterprise administration, address of nearby pharmacies;
11. Availability of an information board in the sales area;
12. Availability of cash registers and registration cards for them;
13. Project and availability:

Electricity supply;
- water supply;
- heating;
- sewerage;
- supply and exhaust ventilation;

14. Results of measurements on the ventilation system, lighting, microclimate;
15. Condition of the surface of walls, ceilings, floors, corresponding to sanitary standards of sanitary and epidemiological supervision;
16. Availability of household equipment (labeled in the prescribed manner);
17. Compliance with the sanitary regime;
18. Availability of equipment: commercial equipment; cabinets that can be locked with a key; metal cabinet or safe; cabinets with locking doors, cabinets for storing outerwear and sanitary clothing.
19. Information on registration of fixed assets;
20. Availability of instruments and apparatus (hygrometers, thermometers in refrigerators);
21. Availability of documents for instruments and apparatus.
22. Verification of devices (presence of a stamp indicating verification on the device and in the passport);
23. Agreement on the protection of the organization;
24. Order on the accepted method of storing medicines;
25. Keeping records of medicines with a limited shelf life;
26. Availability of logs for recording air parameters;
27. Compliance with storage conditions for medicines that require protection from exposure to elevated temperatures (refrigerators);
28. Compliance with storage conditions for medicines that require protection from exposure to light (lockable cabinets);
29. Compliance with storage conditions for medicines that require protection from various environmental factors and special storage conditions (from moisture, from volatilization and drying, from exposure to gases, odorous and coloring medicines.)
30. Compliance with storage conditions for medicinal plant materials;
31. Compliance with storage conditions for parapharmaceutical products;
32. Compliance with established rules for dispensing medicines from pharmacies;
33. Presence of a stamp “The drug is dispensed”
34. Order on the appointment of a quality commissioner;
35. Plans and topics for advanced training classes;
36. Availability of documents confirming the quality of medicines (certificates, invoices, delivery notes);
37. Availability of the necessary information on medicines and other goods sold from a pharmacy organization;
38. Staffing;
39. Work experience of the manager (at least 3 years in the position of pharmacist);
40. Information on the education of employees of a pharmacy organization;
41. Availability of certificates for pharmacy specialists;
42. Medical records of pharmacy employees;
43. Internal labor regulations;
44. Job descriptions;
45. Evacuation plan;
46. Order on the person responsible for safety, fire safety, labor protection;
47. Increasing the professional education of employees (once a quarter);
48. Internal checks for compliance with OST requirements (frequency, availability of protocols)
49. Availability of documents for finishing materials;
50. Availability of regulatory documents in the field of pharmaceutical activities;
51. Availability and correct execution of accompanying documents when delivering goods to a pharmacy: delivery notes, invoices, price approval protocols, etc.;
52. Availability and frequency of preparation of commodity reports;
53. The level of trade margins for medicines included in the list of vital and essential drugs.
54. Compliance with storage conditions for List A drugs;

Additionally for pharmacies working with PKKN:

55. *Register of poisonous, narcotic, other medicines and ethyl alcohol;

56. * Conclusion of the internal affairs bodies on the technical strength of the pharmacy for storing medications. agents included in the lists of poisonous and potent lists of the PKKN;

57. *. Compliance with the storage conditions of medicines included in the PKKN lists;
58. *Subject-quantitative accounting;

* if you intend to sell poisonous, psychotropic, potent drugs on the PKKN list;

All documents are provided in photocopies if the originals are available, or certified by a notary;
photocopies are certified independently by the licensee enterprise;