How to obtain a license for pharmaceutical activities?

Which authorities issue licenses?

You can obtain a license for pharmaceutical activities from the following authorities:

The procedure for obtaining a license to engage in pharmaceutical activities can be divided into 3 stages:

Who needs a pharmaceutical license for wholesale or retail trade?

Today there are 3 types of pharmaceutical licenses - for retail, wholesale trade or production of medicines. The permit is valid throughout the Russian Federation, regardless of the region in which it was received. A license can be granted by both an entrepreneur and legal entities. It is required by the following organizations:

• Pharmacies for people and animals;
• Medical organizations and their separate divisions;
• Companies providing veterinary services.

In order to be granted permission, you will need to pay a state fee of 7,500 rubles.

Deciding on services

Pharmaceutical activities include two areas - the circulation of medicines for medical purposes and the circulation of medicines for veterinary use. In each direction, a specific list (of services) is allocated.

Types of services for the circulation of medicines for medical purposes

• wholesale trade in medicines;
• storage of medicines (drugs);
• transportation of medicines (drugs);
• retail trade in medicines;
• dispensing of medications;
• production of medicines.

Types of services for the circulation of medicines for veterinary use

• wholesale trade in medicines;
• storage of medicines (drugs);
• transportation of medicines (drugs);
• retail trade in medicines;
• dispensing of medications;
• production of medicines.

Legislation on licensing of pharmaceutical activities

The general procedure for licensing pharmaceutical activities is regulated by four legislative acts:

1. Federal Law No. 99-FZ dated 04.05.2011 “On licensing of certain types of activities”;
2. Decree of the Government of the Russian Federation of December 22, 2011 No. 1081 “On licensing of pharmaceutical activities”;
3. Decree of the Government of the Russian Federation of December 22, 2011 No. 1085 “On licensing activities for the circulation of narcotic drugs and psychotropic substances”;
4. Federal Law of November 21, 2011 No. 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation.”

Particular attention should be paid to Resolution No. 1081. The appendix to this act contains a list of work performed and services provided that constitute pharmaceutical activities.

We check compliance with licensing requirements

If you are just planning to start a business, you will need to open an LLC or register an individual entrepreneur and ensure compliance with established licensing requirements.

If the business is already operating and you decide to engage in pharmaceutical activities, you need to make changes to OKVED LLC or, and also check compliance with licensing requirements.

Licensing requirements for pharmaceutical activities in the medical field:

• availability of premises and equipment on the right of ownership (other legal basis) necessary for the performance of work (services);
• The head of an organization involved in the wholesale trade of medicines (storage, transportation and (or) retail trade, their dispensing, storage, manufacturing) has a higher pharmaceutical education and work experience in the specialty of at least 3 years or a secondary pharmaceutical education and work experience in specialty for at least 5 years, specialist certificate;
• the presence of employees who have entered into employment contracts, whose activities are directly related to the wholesale trade of medicines (storage and (or) retail trade, dispensing, storage and manufacturing) - higher or secondary pharmaceutical education, specialist certificates.

Licensing requirements for pharmaceutical activities in the field of veterinary medicine:

• availability of premises and equipment on the right of ownership (other legal basis) necessary for the performance of work (services);
• the head of an organization involved in the wholesale trade of medicines (storage, transportation and (or) retail trade, their dispensing, storage, manufacturing) has a higher or secondary pharmaceutical or higher or secondary veterinary education, work experience in the specialty of at least 3 years, specialist certificate;
• the presence of employees who have entered into employment contracts, whose activities are directly related to the wholesale trade of medicines (storage and (or) retail trade, dispensing, storage and manufacturing) - higher or secondary pharmaceutical or veterinary education, specialist certificates.

note

, that if you are not only an LLC or individual entrepreneur, but also an active medical organization, there is an additional licensing requirement for having a license for medical activities.

On the requirements for pharmaceutical enterprises

All conditions that are established at the state level for enterprises seeking permission to operate in the pharmaceutical field are divided into two groups:

• applicable to those wishing to obtain a license;
• applicable to those already licensed.

The former must have qualified personnel, managers, and premises for conducting activities. The latter will have to provide data on the availability of premises, qualifications of personnel, as well as confirmation of compliance with legal requirements that relate to trade, circulation, storage and other operations related to medicines.

We submit the documents necessary to obtain a license

The general algorithm and terms for consideration of the application are described here; the distinctive feature will be only the application form and the list of attached documents. To obtain a license to carry out pharmaceutical activities, a special application () is submitted to the licensing authority.

The following documents are attached to the application:

List of documents for an application for pharmaceutical activities in the field of medicine

• copies of documents confirming the availability of premises and equipment on the right of ownership (other legal basis) necessary for the performance of work (services);
• information about the availability of a sanitary-epidemiological report on the compliance of the premises with the requirements of sanitary rules;
• copies of documents on higher or secondary pharmaceutical education and certificates of specialists;
• copies of documents on additional professional education in the retail trade of medicinal products for medical use and on the availability of the right to carry out medical activities;
• copies of documents that confirm the presence of the required work experience in the specialty of the head of the organization, individual entrepreneur;
• information about the availability of a license to carry out medical activities (only for medical organizations).

List of documents for an application for pharmaceutical activities in the field of veterinary medicine

• copies of documents confirming the availability of premises and equipment on the right of ownership (other legal basis) necessary for the performance of work (services);
• information about the availability of a sanitary-epidemiological report on the compliance of the premises with the requirements of sanitary rules;
• copies of documents on higher or secondary pharmaceutical (veterinary) education and specialist certificates;
• copies of documents that confirm the presence of the required work experience in the specialty of the head of the organization, individual entrepreneur;
• information about the availability of a license to carry out medical activities (only for medical organizations).

Methods for submitting documents

Documents can be submitted in one of the following ways:

• personally or through a representative by proxy;
• by mail with acknowledgment of delivery;
• in electronic form, signed with digital signature.

Documents are accepted according to the inventory, a copy of which is marked with the date of receipt. A copy with a mark is handed over to the applicant or transferred to him in the manner in which they were received.

Cancellation of a license for pharmaceutical activities

The suspension and subsequent termination of a license for various types of pharmaceutical activities is regulated by the general provisions of Federal Law No. 99-FZ.

According to the law, cancellation can only be carried out by a court decision after an application from the authority that issued the license. It occurs in the following cases:

• gross violation of licensing requirements;
• failure to comply with an order to eliminate a gross violation of licensing requirements.

It is important to note that cancellation of a license is possible only after the suspension of its activities and a period when the violator is given the opportunity to eliminate inconsistencies in the work.

After obtaining a license

Having issued a license, a company or individual entrepreneur has the right to begin carrying out pharmaceutical activities, but it is important to remember about possible scheduled and unscheduled checks for compliance with the requirements of licensing legislation. If violations are detected, the license may be suspended or revoked.

If, in the course of its activities, changes are made to the LLC or some such changes may entail the need to re-issue the license. The state fee for re-registration is 3,500 rubles.

Pharmaceutical registration services. licenses

• Zoning the pharmacy area in accordance with licensing requirements;
• Preparation and verification of constituent documents;
• Preparation of a lease agreement for the premises;
• Assistance in purchasing real estate for a pharmacy;
• Submission of documents to Rospotrebnadzor;
• Preparing pharmacy premises for inspection;
• Obtaining a conclusion from the SES;
• Preparation for inspection by Roszdravnadzor;
• Search for pharmacists who meet licensing requirements;
• Concluding labor agreements with employees;
• Verification of diplomas of hired personnel;
• Assistance with the purchase, leasing of equipment for sale, preparation of medicines in a pharmacy.

Requirements for registration

An applicant wishing to have a permit must:

• Own the premises on the basis of a title document or a lease agreement.
• Have specialized machines, units and technical means.
• Possess documents confirming that specialists have appropriate education, have completed accreditation, internships, and advanced training courses.
• Apply for permission to provide medical and other medical services (we are talking about a medical organization).
• Employ qualified employees within the regulatory requirements of the law.

Important! From 2020 there is no requirement to provide certificates. In accordance with the amendments to the law, it is necessary to send a certificate of accreditation. The law also specifically states what length of experience a medical specialist must have for the production and marketing of pharmaceuticals.

List of documents

• Registration papers - the corresponding certificate of the Unified State Register of Legal Entities or Unified State Register of Individual Entrepreneurs, an extract from the registration department, a notification from Rosstat about the assignment of data.
• Constituent documentation – Charter with the latest amendments for 2020, decision or protocol on the creation of a legal entity and other constituent materials.
• Personnel documentation - diplomas of medical education, work books indicating work experience, Orders, and so on.
• Title papers - a document on ownership of the object or a lease agreement, as well as technical documentation for production premises (here we are talking about the drug manufacturer).
• Application of the established form for the provision of a permit.
• Payment papers for payment of state duty.

Manufacturers must additionally provide documents confirming that the equipment complies with approved norms and standards and can be used for the manufacture of medicines. All copies of documentation must be certified by a notary. The set of papers is usually sent by registered mail or by email. In the latter case, the digital signature of the general director of the medical organization must be affixed.

Refusal to license pharmaceutical activities

In some cases, you may be denied a license. Reasons: the documents contain false information or the applicant does not meet legal requirements.

Notification of refusal is sent in writing with a mandatory listing of all violations. If you consider the decision of a government agency to be illegal, you can appeal it in court. To do this, you need to file a claim and demand an independent examination of your papers.

Carefully fill out the application and provide all the necessary papers, otherwise they will refuse to issue a license.

Working without a license entails bringing the head of an organization or individual entrepreneur to administrative or criminal liability, so you should not tempt fate. It’s better to fill out the necessary paperwork and work calmly.