Pharmacy licensing procedure: requirements and deadlines
Entrepreneurs planning to open a pharmacy outlet should know that they need to obtain a license for their activities. What types of pharmacies exist in the Russian Federation and what licensing requirements apply to them will be discussed in this article.
Contents of the article:
- What types of pharmacies are there?
- Regulatory regulation for licensing pharmacies
- Requirements for obtaining a license
- Procedure for obtaining a license
- License validity period
- Cost of licensing services
- What are the risks of working without a license?
- Conclusion
below are the licensing requirements for pharmacies. The most popular form of doing pharmaceutical business in Russia is this form of doing pharmaceutical business.
What types of pharmacies are there?
There are three types.
- Pharmacy kiosks;
- Pharmacy points;
- Pharmacies.
In accordance with the order of the Ministry of Health and Social Development of the Russian Federation dated July 27, 2010 “On approval of types of pharmacy organizations,” there are three types of pharmacies.
Pharmacies can prepare dosed products (DF) and products with sterile blocks (produce DF according to individual recipes). As a rule, only industrial pharmacies are not found. It doesn’t do any good. That’s why they open GLF pharmacies in the manufacturing sector.
These types were approved by order of the Ministry of Health and Social Development of the Russian Federation dated July 27, 2010.
What are the differences between these types of pharmacies? The easiest way is to get a permit for a pharmacy kiosk. Despite the most lenient requirements, this type of pharmacy organization has significant limitations. Pharmacy kiosks cannot dispense prescription drugs. Their range may only include medications that do not require a doctor’s prescription. This is not very profitable in this case, since numerous drugs and buyers fall out of the assortment.
Pharmacies can dispense prescription drugs, but the requirements for pharmacies when obtaining a license are more stringent. Obtaining a pharmacy license is the most difficult, especially in the manufacturing sector. Indeed, in addition to additional equipment and space, the production department requires at least four additional employees.
Therefore, a pharmacy is a necessity if the pharmacy business is a new direction for entrepreneurs, when it is planned to sell only finished drugs without a prescription and over-the-counter.
Regulatory regulation for licensing pharmacies
Pharmaceutical activities are defined by Federal Law-61 “Circulation of Medicines” as activities related to the production, storage, transportation and dispensing (sale) of medicines.
It is important to note that this is not talking about medical devices. The sale of medical products is not a pharmaceutical activity, but its implementation in pharmacies is not prohibited. It is worth noting that not all products can be sold at pharmacy kiosks or pharmacies.
ATTENTION! Products that can be sold by pharmacies specified in Federal Law-61.
The need to obtain a license for pharmaceutical activities in the Russian Federation is determined by Article 12 (Part 47) of Federal Law No. 99 “On Licensing of Certain Types of Activities”.
Specific requirements are determined by Decree of the Government of the Russian Federation No. 1081 “On licensing of pharmaceutical activities”.
Requirements for obtaining a license
A number of requirements are proposed to obtain this type of license. on premises, personnel and future pharmacy equipment. They are discussed in more detail below.
To the premises
To obtain a pharmacy license, you must have premises that meet certain requirements.
To obtain a pharmacy license, the applicant must have premises with certain parameters. The area of the pharmacy site must be at least 20 square meters. m, if the point is located on the territory of a medical institution, or at least 38 square meters. m, if the pharmacy is located in a building of a different profile.
In addition to local requirements, the pharmacy must
- He has his own premises;
- The point has a separate entrance;
- Ability to load and unload goods;
- The building in which the pharmacy is located must have sewerage, ventilation, heating, water supply and fire extinguishing systems;
- Availability of necessary equipment;
- Availability of space: reception, storage and trade of goods; employee workplaces.
To the equipment
The pharmacy must provide the following basic elements
- Refrigerators for storing thermally unstable drugs;
- Easily disinfected furniture;
- Ceramic tiles on the floor;
- No hollow partitions;
- Entrances must have rubber mats and be cleaned at least once a day;
- It is mandatory to provide access to points for persons with disabilities or install bells at entrances;
- Showcases must be protected from sunlight. This is due to the fact that the blinds project onto the windows;
- The pharmacy must have a device for recording air parameters;
- Trade equipment;
- Cleaning equipment;
- Approved equipment.
To the staff
Pharmacy license determines requirements for employees. Only pharmacists or pharmacists can work at the first table. Compliance with these requirements is mandatory for pharmacies.
- The pharmacy director must have a higher pharmaceutical education, at least three years of work experience and a specialist certificate. You can hire specialists with secondary pharmaceutical education, but only if they have at least five years of work experience and a professional certificate before they can take a leadership position;
- Full-time employees must present a pharmaceutical education diploma and professional certificate;
- Graduates of higher education institutions after 2016 present an accredited diploma or certificate. Until 2022, there is a dual system of admission to pharmaceutical activities. Employees with secondary pharmaceutical education are not yet included in the accreditation system;
- All employees are required to have access to medical records, and medical examinations are carried out annually;
- Advanced training every five years.
Procedure for obtaining a license
The procedure for obtaining a license consists of several stages.
- An entrepreneur is looking for premises and staff;
- All necessary documents are collected;
- An application is submitted and a fee is paid;
- A decision is awaited.
Important! When you first apply for a license, you must be prepared for the arrival of an inspector from the territorial department of Roszdravnadzor. In addition, representatives of regulatory authorities attend scheduled and unscheduled inspections. Unscheduled inspections are carried out in the event of complaints from the public.
Where to get a pharmacy license
After preparing the documentation, an application is submitted to the territorial office of the Federal Medical Supervision Authority at the place of intended operation of the pharmacy.
If you are planning to open a pharmacy for animals, you need to contact the Federal Office for Veterinary Supervision in the place where you plan to locate it.
If a license is required only in a specific region or territory, documentation can be submitted to the city or regional ministry of health.
Required documents
Regardless of the entrepreneur’s registration form, the following documents must be submitted to the local office of Roszdravnadzor:
- Application in the prescribed form;
- Order appointing the chief accountant and manager;
- Ownership or annual lease of the premises in which the pharmaceutical activities will be carried out;
- Proof of payment for the procedure (7, 500 rubles);
- Certificates of specialists and pharmacy managers; and educational diplomas;
- Employee work records;
- SES and fire inspection determination;
- BTI plan;
- Data confirming that the equipment is certified.
In addition to the above documents, additional documents must be submitted in accordance with the entrepreneur’s registration.
A legal entity will be provided with:
- Document on the organizational structure;
- Certificate of state registration of the legal entity;
- The organization’s IIN;
- Information from the Unified State Register of Legal Entities. Individual entrepreneurs must provide:
Certificate of state registration of individual entrepreneur;
- Information from the Unified State Register of Individual Entrepreneurs;
- Taxpayer Identification Number (TIN).
- A notarized copy. Licensing authority employees are not entitled to request documents not specified in licensing regulations.
Processing Time
Terms of consideration
Up to 45 business days for first-time license registration;
- Up to 30 business days for review;
- Up to 10 business days for changing the name or passport details of an individual entrepreneur’s company.
- License revocation: up to 5 business days;
- Duplicate production: up to 3 business days;
- Extract from the register: up to 5 business days.
- If the decision is positive, the form is issued on the third business day after the license is registered in the License Register.
License Validity
License validity period
However, license renewal may be mandatory.
Reorganization;
- Change of name and IP passport information;
- Addition of address;
- Addition or deletion of work types. For example, opening or closing a pharmacy production department.
- Cost of Licensing Services
Cost of licensing services
Issuing a new license for the first time costs 7, 500 rubles;
- Issuing a duplicate costs 750 rubles;
- Re-registration due to reorganization – 750 rubles;
- Replacing a license for other reasons – 3, 500 rubles.
- Penalties for operating without a license
What are the risks of working without a license?
Inconsistencies between facilities. For example, after some time, part of the premises was leased for other purposes;
- Violation of dispensing rules. For example, leaving medications without a prescription;
- Failure to meet minimum product range requirements;
- Violation of medication storage requirements;
- Price violations;
- Counterfeiting, adulteration, or substandard use of medications.
- To identify serious violations of authorized requirements:
Sole proprietors pay a fine of up to 8, 000 rubles or have their activities suspended for up to 90 days;
- Legal entities pay a fine of up to 200, 000 rubles or have their activities suspended for up to 90 days.
- Conclusion
Conclusion
Pharmacy Licensing Procedure: Requirements and Deadlines
