Licensing control activities. Licensing control over pharmaceutical activities

The procedure for exercising licensing control is enshrined in Art. 19 of Law N 99-FZ. Thus, the Law establishes that the controlling body, which in this case is the licensing body, conducts inspections in relation to the licensee and the license applicant.

Checks can be documentary, unscheduled on-site (in relation to the license applicant and the licensee), as well as planned (in relation to the licensee). Unscheduled on-site inspections in relation to the license applicant are carried out without the consent of the prosecutor's office (part 2 of article 19 of Law N 99-FZ). In accordance with parts 6 and 12 of Art. 19 of this Law, unscheduled field inspections in relation to the licensee are also carried out without the consent of the prosecutor's office. An exception is made when such an inspection is carried out on the basis of an appeal or application from citizens or legal entities and other persons (clause 2 of part 10 of article 19 of the Law). V this case unscheduled on-site check can be carried out without prior notice to the person being checked.

Scheduled inspections are carried out in accordance with an annual plan developed by the licensing authority. Law N 99-FZ lists the grounds for including scheduled inspection licensee in the annual plan of scheduled inspections. In accordance with Part 9 of Art. 19 of the said Law, such grounds are:

  • · Expiration of one year from the date of the decision to grant a license or renew the license;
  • · Expiration of three years from the date of completion of the last scheduled inspection of the licensee;
  • · Expiration of the period established by the Government of the Russian Federation from the date of the end of the last scheduled inspection of the licensee carrying out a licensed type of activity in the spheres of health care, education, and in the social sphere.

An unscheduled field check of the licensee can be carried out on the following grounds (part 10 of article 19 of Law N 99-FZ):

  • · Expiration of the term for execution by the licensee of the order previously issued by the licensing authority to eliminate the detected violation;
  • Submission to the licensing authority of applications and applications of citizens and legal entities, information from authorities state power and local government, mass media about the facts of gross violations of license requirements by the licensee;
  • · Expiration of the period for which the license was suspended;
  • · The presence of a licensee's petition for the licensing authority to conduct an unscheduled on-site inspection in order to establish the fact of early execution of the instructions of the licensing authority;
  • · The presence of an order (instruction) issued by the licensing authority in accordance with the instruction of the President of the Russian Federation or the Government of the Russian Federation.

The Law states that an exhaustive list of gross violations of licensing requirements in relation to each licensed type of activity must be established by the corresponding regulation on licensing. Moreover, in accordance with Part 11 of Art. 19 of Law N 99-FZ, such violations of licensing requirements may include violations that entailed:

  • The emergence of a threat of harm to life, health of citizens, harm to animals, plants, environment, objects cultural heritage(historical and cultural monuments) of the peoples of Russia, as well as threats emergencies technogenic character;
  • Human sacrifice or infliction grievous harm health of citizens, causing moderate harm to the health of two or more citizens, harm to animals, plants, the environment, cultural heritage objects (historical and cultural monuments) of the peoples of Russia, the occurrence of man-made emergencies, damage to the rights, legitimate interests of citizens, the defense of the country and the security of the state.

When exercising licensing control, the licensing authority has the right to receive information confirming the accuracy of the information and documents provided, using the Internet in accordance with Russian legislation regulating the issues of providing access to information.

From December 26, 2008 N 294-FZ "On the protection of the rights of legal entities and individual entrepreneurs in the implementation state control(supervision) and municipal control"taking into account the specifics of the organization and conduct of inspections established by parts 2-10 of this article, as well as federal laws regulating the implementation of activities in accordance with part 4 of Article 1 of this Federal law... The procedure for organizing and exercising licensing control over a specific type of activity is established by the regulation on licensing a specific type of activity, approved by the Government Russian Federation.

2. In respect of the license applicant who has submitted an application for a license, or the licensee who has submitted an application for re-issuing a license, in the cases provided for by this Federal Law, the licensing authority conducts unscheduled inspections without the consent of the prosecutor's office in the prescribed manner.

3. In accordance with part 2 of this article, the basis for conducting an inspection of a license applicant or licensee is the submission to the licensing authority of an application for a license or an application for renewal of a license.

4. The subject of documentary verification of a license applicant or licensee is the information contained in the submitted applications and documents in order to assess the compliance of such information with the provisions of Parts 1 and 3 of Article 13 and Part 3 of Article 18 of this Federal Law, as well as information about the license applicant or licensee, contained in the unified state register of legal entities, the unified state register of individual entrepreneurs and other federal information resources.

5. The subject of an unscheduled on-site inspection of a license applicant or licensee in the cases provided for by parts 7 and 9 of Article 18 of this Federal Law is the condition of premises, buildings, structures, technical means, equipment, other objects that are supposed to be used by the license applicant or the licensee in the implementation of the licensed type of activity, and the availability of employees necessary for the implementation of the licensed type of activity in order to assess the compliance of such facilities and employees with licensing requirements.

6. In respect of the licensee, the licensing authority carries out documentary inspections, scheduled inspections and unscheduled field inspections in accordance with Part 10 of this Article. These unscheduled field inspections are carried out without the consent of the prosecutor's office, with the exception of an unscheduled field inspection on the basis specified in paragraph 2 of part 10 of this article. The regulation on licensing a specific type of activity may establish that when exercising licensing control over a specific type of activity, scheduled inspections are not carried out, or that when exercising licensing control over a specific type of activity carried out using a risk-based approach, scheduled inspections of licensees are not carried out depending on attribution of the activities of licensees and (or) used by them production facilities to a certain category of risk, a certain class (category) of hazard.

7. The subject of the licensee's inspections specified in part 6 of this article is the information contained in the licensee's documents about his activities, the state of premises, buildings, structures, technical means, equipment, other objects used in the implementation of the licensed type of activity, compliance of the licensee's employees with licensing requirements, work performed , services rendered, measures taken by the licensee to comply with license requirements, to comply with instructions to eliminate identified violations of license requirements.

8. Scheduled inspection of the licensee is carried out in accordance with the annual plan of scheduled inspections, developed in accordance with the established procedure and approved by the licensing authority.

9. Scheduled inspections of licensees are carried out:

1) not earlier than one year from the date of the decision to grant the license;

3) in accordance with the frequency, established by regulation on licensing for licensing control carried out using a risk-based approach;

4) in accordance with the frequency established by the Government of the Russian Federation for scheduled inspections of a licensee carrying out a licensed type of activity in the spheres of healthcare, education, and in the social sphere.

10. An unscheduled field check of the licensee is carried out on the following grounds:

1) expiration of the term for execution by the licensee of an order previously issued by the licensing authority to eliminate the revealed violation of license requirements;

2) submission to the licensing body of applications, applications of citizens, including individual entrepreneurs, legal entities, information from public authorities, local authorities, the media about the facts of gross violations of license requirements by the licensee;

4) the presence of a licensee's petition for the licensing authority to conduct an unscheduled on-site inspection in order to establish the fact of early execution of the instructions of the licensing authority;

5) the presence of an order (instruction) issued by the licensing authority in accordance with the instruction of the President of the Russian Federation or the Government of the Russian Federation.

11. An exhaustive list of gross violations of licensing requirements in relation to each licensed type of activity is established by the regulation on licensing a specific type of activity. At the same time, such violations of licensing requirements may include violations that entailed:

1) the emergence of a threat of harm to the life, health of citizens, harm to animals, plants, the environment, cultural heritage objects (historical and cultural monuments) of the peoples of the Russian Federation, as well as the threat of technogenic emergencies;

2) human casualties or serious harm to the health of citizens, moderate harm to the health of two or more citizens, harm to animals, plants, the environment, cultural heritage objects (historical and cultural monuments) of the peoples of the Russian Federation, the occurrence of man-made emergencies, causing damage to the rights, legitimate interests of citizens, the defense of the country and the security of the state. Federal Law No. 93-FZ of June 25, 2012, Article 19 of this Federal Law was supplemented with part 15

15. Annually federal authorities executive power and the executive authorities of the constituent entities of the Russian Federation that carry out licensing of specific types of activities, in the manner prescribed by the Government of the Russian Federation, prepare reports on licensing, on the effectiveness of such licensing and submit these reports to the authorized by the Government of the Russian Federation federal body executive authority preparing an annual summary report on the status of licensing, including through the federal state information system, the procedure for the formation and maintenance of which is determined by the Government of the Russian Federation.

In market conditions, pharmaceutical activities are becoming more complex. This is due to the financial and economic activities of both individual pharmacy organizations and pharmacy chains. different forms property. In this regard, the need state regulation types of activities in the field of circulation medicines not only does not decrease, but increases significantly.

Supervision and control bodies exercise control over the observance of norms and rules in the field of regulated types of activity. With the beginning of the implementation of the administrative reform, licensing issues in the field of drug circulation were transferred to the federal level, and the licensing body is the Federal Service for Supervision of Healthcare and social development... The functions of supervision and control in the field of pharmaceutical activities are divided: the Ministry of Health and Social Development of Russia develops and approves the rules and regulations governing activities in the field of drug circulation, and Roszdravnadzor, in accordance with the Decree of the Government of the Russian Federation of June 30, 2004 No. 323, controls their implementation using different kinds and methods of supervision and control, including licensing control.

In this regard, licensing control should be considered as a specific management activity, one of the main functions and a permanent and effective management factor. In the Federal Law of 02.07.2005, No. 80-FZ, a separate article is devoted to licensing control (Article 12 “ License control"). It is set out in a wording that significantly differs from a similar article of the Law "On Licensing certain types activity "dated 08.08.2001.

No. 128-FZ. In accordance with this article, licensing control is carried out by the licensing authority in order to verify the completeness and reliability of the information about the license applicant contained in the application and documents submitted by the license applicant, the possibility of fulfilling the license requirements and conditions, as well as verifying information about the licensee and compliance with the license requirements, and conditions for the implementation of the licensed type of activity.

The forms of control are preliminary control (at the stage of obtaining a license) and subsequent control over compliance by license holders with the conditions under which they were issued. Taking into account the accumulated experience of licensing commissions and the powers of the federal executive body in the field of licensing pharmaceutical activities, the following tasks and principles of organizing licensing control can be distinguished:

  • - formation of tactics of organization and methodology of state licensing control over compliance by licensees with license requirements and conditions;
  • - determination of the improvement of the licensing control mechanism;
  • - coordination of practical measures between Roszdravnadzor, other ministries and departments in order to avoid duplication and parallelism in the implementation of license control;
  • - approval of plans for joint inspections with other departments (Ministry of Internal Affairs, Prosecutor's Office, Gosnarkokontrol, etc.), carried out by decision of Roszdravnadzor.

The principles of organizing licensing control can be formulated as follows: independence, which must be ensured by financial independence control body and securing the status of inspectors (experts) in normative act; competence and objectivity - strict adherence by experts current legislation in the field of licensing, a high professional level of work of experts based on established order carrying out licensing control; glasnost - constant communication of experts of licensing commissions with representatives public control and the media; the validity and validity of the information provided in the inspection reports; consistency of actions of various regulatory bodies.

The Central Licensing Commission for Pharmaceutical Activities of Roszdravnadzor continues to work on proposals for improvement legal framework licensing control and control mechanisms entrepreneurial activity in the field of medicines circulation.

1. Actions (inaction) officials Moscow Housing Inspection, as well as the decisions they make during the execution state function can be appealed in pre-trial order.

2. The subject of appeal may be the actions (inaction) of officials of the Moscow Housing Inspectorate upon the appeal of a legal entity, an individual entrepreneur licensed to carry out entrepreneurial activities in management apartment buildings, which was checked, about the violation of his rights and legitimate interests, illegal decisions, actions (inaction) of officials of the Moscow Housing Inspectorate, violation of the provisions of the Regulations, incorrect behavior or violation service ethics.

3. Persons in respect of whom measures have been taken (are being carried out) related to the performance of state functions (hereinafter referred to as interested persons) may report a violation of their rights and legitimate interests, unlawful decisions, actions (inaction) of officials of the Moscow Housing Inspectorate, violation of the provisions of this Regulation , incorrect behavior or violation of official ethics to the Moscow Housing Inspectorate by phone numbers, postal addresses, addresses Email, with a personal reception in the manner prescribed legal acts Of the Russian Federation, legal acts of the city of Moscow.

4. The answer to the complaint (appeal) is not given in the cases established by Art. 11 of the Federal Law of May 2, 2006 N 59-FZ.

5. The basis for starting a pre-trial (out-of-court) appeal is the receipt of an oral or writing, including in the form electronic document, complaints (appeals) from an interested person to the Moscow Housing Inspection.

6. When considering a complaint (appeal), interested persons enjoy the rights established by Federal Law No. 59-FZ of May 2, 2006.

7. Interested persons can apply in a pre-trial (out-of-court) manner with a complaint (appeal):

To the head of the Moscow Housing Inspection;

To the Deputy Mayor of Moscow in the Moscow Government for housing and communal services and improvement;

To the Mayor of Moscow;

To the prosecutor's office of the Russian Federation.

8. A complaint received by the Moscow Housing Inspectorate is subject to consideration by an official authorized to consider complaints (appeals) within 30 days from the date of its registration.

9. An official of the Moscow Housing Inspection, upon receiving a complaint containing obscene or offensive language, threats to the life, health and property of the official, as well as his family members, has the right to leave the complaint unanswered on the merits of the questions raised in it and inform the citizen who sent the complaint, on the inadmissibility of abuse of the right.

10. If an answer on the merits of the question posed in the appeal cannot be given without disclosing information constituting a state or other secret protected by the legislation of the Russian Federation, the applicant who sent the appeal shall be informed within 7 (seven) days from the date of registration of the complaint about the impossibility of giving the answer to the essence of the question posed in it due to the inadmissibility of disclosing the specified information.

11. If the complaint contains a question to which the applicant was repeatedly given written answers on the merits in connection with previously sent complaints, and the complaint does not provide new arguments or circumstances, the officials of the Moscow Housing Inspectorate have the right to decide on the groundlessness of the next complaint and termination of correspondence with applicant for this issue provided that the said complaint and the previously sent complaints were sent to the same address or to the same official. The applicant who sent the complaint is notified of this decision.

12. If documents that are essential for the consideration of the complaint are absent or are not attached to it, the applicant within five days from the date of registration of the complaint is notified (in writing, using telephone or e-mail) that the consideration of the complaint and the adoption of a decision will be carried out without taking into account the arguments in support of which documents have not been submitted.

13. Officials of the Moscow Housing Inspectorate provide an objective, comprehensive and timely consideration of the appeal, if necessary:

With the participation of the applicant who sent the complaint or his legal representative.

Has the right to request, including in electronic format documents and materials necessary for consideration of the complaint in other state bodies, local self-government bodies and other officials, with the exception of courts, inquiry bodies and preliminary investigation bodies.

Based on the results of the consideration of the complaint, measures are taken to restore or protect the violated rights, freedoms and legitimate interests of the applicant, give a written answer on the merits of the questions raised in the complaint.

Notify the applicant about the direction of his appeal for consideration in another government agency, local government body or other official in accordance with their competence.

14. If necessary, an applicant who has applied to the Moscow Housing Inspectorate with a complaint about the actions (inaction) of its officials has the right to receive copies of documents and materials relating to the substance of his complaint, confirming the correctness and reliability of the facts stated in his appeal and necessary to substantiate and consideration of the complaint.

15. A complaint submitted in writing must contain:

The name of the state body or local self-government body to which it sends written request, or position, surname, first name and patronymic (if any) of the official (if information is available), the decision, action (inaction) of which is being appealed.

Surname, name, patronymic (if any) of the applicant's representative or the full name of the organization.

The mailing address to which a response or notification of complaint forwarding should be sent.

Subject of the complaint.

Applicant's personal signature and date.

Additionally, the complaint may indicate the circumstances on the basis of which the applicant believes that his rights, freedoms and legitimate interests have been violated, that obstacles have been created for their implementation, or that any obligation has been illegally imposed, and other information that the applicant considers necessary to report.

16. Copies of documents confirming the circumstances stated in it may be attached to the complaint.

17. The complaint is filed with the Moscow Housing Inspection and is considered, respectively, by the head (deputy head) of the Moscow Housing Inspection.

18. The term for consideration of a complaint (appeal) may be extended by no more than 30 days in case of sending a request to other organizations to receive the documents and materials necessary for consideration of the appeal.

19. Complaint filed electronic document management, should contain:

Surname, name, patronymic of the applicant's representative or the full name of the organization;

Email address, if the response is to be sent in the form of an electronic document;

Mailing address, if the response is to be sent in writing.

The applicant has the right to attach to such an appeal Required documents and materials in electronic form or send the specified documents and materials or their copies in writing.

20. Based on the results of consideration of the complaint (appeal), an official of the Moscow Housing Inspectorate, empowered on consideration of complaints (appeals), makes one of the following decisions:

On taking measures aimed at restoring or protecting violated rights, freedoms and legitimate interests of the applicant, other persons, violated interests of society or the state.

Refusal to take action due to lack of grounds.

On notifying the applicant of sending his complaint (appeal) for consideration to another state body, local self-government body or other official in accordance with their competence.

On the termination of the correspondence.

§ 5.1. The concept of licensing control and normative legal consolidation of the procedure for exercising license control

Licensing control is carried out by the licensing body in order to verify the completeness and reliability of the information about the license applicant contained in the application and documents submitted by the license applicant, the possibility of fulfilling the license requirements and conditions, as well as checking the information about the licensee and his compliance with the license requirements and conditions in the implementation of the licensed type activities.

Licensing control is carried out in accordance with:

The Law of the Russian Federation "On Education" (Art. 33.1);

Regulations on the licensing of educational activities, approved by the Government of the Russian Federation of March 16, 2011 No. 000;

Federal Law of 01.01.2001 "On the Protection of the Rights of Legal Entities and Individual Entrepreneurs in the Exercise of State Control (Supervision) and Municipal Control";

Federal Law of 01.01.2001 "On Licensing Certain Types of Activities";

Federal Law No. 99-FZ of 01.01.2001 "On Licensing Certain Types of Activities".

§ 5.2. Licensing control procedure

In accordance with Art. 33.1 of the Law of the Russian Federation "On Education" after one year after the grant of the license, the licensing authority conducts a scheduled on-site inspection of the licensee's compliance with the license requirements and conditions.

The expiration of one year from the date of the decision to grant a license is the basis for the inclusion of a scheduled inspection of the licensee in the inspection plan for the corresponding calendar year.

Monitoring the possibility of the license applicant or licensee fulfilling the license requirements and conditions (upon granting a license and re-issuing a document confirming the existence of a license), monitoring the licensee's compliance with license requirements and conditions during implementation educational activities(hereinafter referred to as license control) is carried out by the licensing authority through scheduled and unscheduled inspections in accordance with the Federal Law "On the Protection of the Rights of Legal Entities and Individual Entrepreneurs in the Exercise of State Control (Supervision) and Municipal Control", the Federal Law "On Licensing Certain Types of Activities" and the Law of the Russian Federation "On Education".

Documentary checks are carried out at the location of the licensing authority by examining documents and information available in the licensing authority and (or) submitted by license applicants, licensees and other persons, as well as by analyzing information posted on official websites educational institutions on the Internet in accordance with paragraphs 4 and 5 of Article 32 of the Law of the Russian Federation "On Education".

On-site inspections are carried out at the location and (or) conduct of activities of license applicants and licensees.

During the audit, measures are taken for licensing control in order to analyze and examine documents and materials characterizing the activities of the organization, means of ensuring the educational process, as well as analyzing the use in the educational process of objects necessary for the implementation of educational activities (buildings, structures, structures, premises and territories ), educational and methodological documentation, educational, educational and methodological literature and other library and information resources and means of ensuring the educational process.

The officials who may be authorized to conduct an inspection by an administrative act of the licensing body include the head of the licensing body, deputy heads of the licensing body, heads and deputy heads structural units licensing authority, other civil servants of the licensing authority, job regulations which provides for an audit on issues of license control.

Experts and expert organizations accredited in accordance with the procedure established by the Government of the Russian Federation, on the basis of an administrative act of the licensing authority and in accordance with civil law contracts concluded with them, are involved in carrying out activities for licensing control.

Decision to engage experts and expert organizations the licensing authority accepts the licensing authority to carry out activities on licensing control on the basis of the results of their selection from among experts and expert organizations accredited for the relevant type of activity. The selection of experts and expert organizations to involve them in carrying out activities for licensing control is carried out in accordance with the selection criteria established by the licensing authority.

In accordance with the terms of the civil law agreement concluded with the expert, the expert is paid remuneration and reimbursed for travel expenses to the location of the organization in respect of which the license control event is being carried out, and back to the expert's place of residence, as well as the cost of renting living quarters for period of stay outside permanent place residence in connection with the activities of licensing control.

In accordance with the terms of the civil law agreement concluded with the expert organization, the expert organization shall be reimbursed for the costs incurred by its representatives for licensing control measures.

Requirements for experts and expert organizations involved in carrying out licensing control activities are approved by the Ministry of Education and Science of the Russian Federation.

Persons authorized to conduct an audit, in order to carry out activities for licensing control, request documents and materials on issues subject to verification, as well as oral and written explanations authorized officials and other employees of the organization on issues subject to verification.

41. Persons authorized to conduct inspections, experts and representatives of expert organizations in order to carry out activities for licensing control have the right:

a) visit the organization in the manner prescribed by the legislation of the Russian Federation, upon presentation of a copy of the administrative act of the licensing authority on the inspection and service ID(other document confirming their powers);

b) carry out the analysis and examination of documents and materials characterizing the activities of the organization on the issues subject to verification, including local and individual legal acts;

c) conduct an inspection and examination of objects used in the implementation of educational activities (buildings, structures, structures, premises and territories);

d) conduct a review and examination of educational and methodological documentation, educational, educational and methodological literature and other library and information resources and means of ensuring the educational process;

e) monitor the progress of the educational process, including the use in the educational process of objects, documentation, literature, other resources and means specified in subparagraphs "c" and "d" of this paragraph;

f) conduct conversations with students, pupils of the organization, their parents ( legal representatives) and employees of the organization on issues to be verified. At the same time, conversations with minor students or pupils are carried out in the presence of their parents (legal representatives).

Persons authorized to conduct an inspection, experts and representatives of expert organizations are obliged to comply with the restrictions during the inspection established by Article 15 of the Federal Law "On the Protection of the Rights of Legal Entities and Individual Entrepreneurs in the Exercise of State Control (Supervision) and Municipal Control".

§ 5.3. Results of the license control

The results of the inspection are documented by an inspection report, to which expert opinions prepared by experts and representatives of expert organizations that took part in the inspection are attached. Based on the inspection report and expert opinions a report on the inspection is drawn up, which is approved by the head (deputy head) of the licensing body. The report on the inspection shall indicate the violations revealed during the inspection and the measures that must be taken in relation to the facts of such violations and the officials who committed them.

In the event of a violation of licensing requirements and conditions, the licensing authority issues an order to the licensee and (or) its founder to eliminate the identified violation. The specified order establishes the term for its execution, which cannot exceed six months. The licensing authority initiates a case on an administrative offense in the manner prescribed by the Code of the Russian Federation on administrative offenses.

The licensee and (or) its founder submit to the licensing authority a report on the execution of the specified order, which includes documents containing information confirming its execution.

In case of non-fulfillment of the specified order by the licensee and (or) its founder (including if the report on the implementation of the specified order is not submitted to the licensing authority before the expiration of the period established by the specified order, or the submitted report does not confirm the execution in set time of the specified prescription), the licensing authority initiates an administrative offense case in the manner prescribed by the Code of Administrative Offenses of the Russian Federation, and suspends the license in full or in relation to individual educational programs, educational activities of the licensee's branch, place of implementation of educational activities for a period not exceeding six months.

The licensing authority, within three days from the date of the decision to suspend the license, makes a corresponding entry in the register of licenses. The licensing authority, within five working days from the date of the said decision, sends a copy of the document confirming the adoption of the corresponding decision, with cover letter to the federal executive body authorized to carry out state registration of legal entities and individual entrepreneurs, at the location of the licensee.

If, before the expiration of the license suspension period, the licensee and (or) its founder have submitted to the licensing authority documents containing information confirming the execution of the order, the failure of which was the basis for the suspension of the license, the licensing authority renews the license.

If such documents are not submitted by the licensee and (or) its founder to the licensing authority before the expiry of the suspension of the license, or the submitted documents do not confirm the fulfillment of the specified order, the licensing authority applies to the court with an application to revoke the license. Suspension of the license is extended for the period before entering into legal force court decisions.

The license is canceled by a court decision on the basis of consideration of the application of the licensing authority.

By decision of the head (deputy head) of the licensing body, information on violation of the legislation of the Russian Federation in the field of education and inspection materials are sent to the law enforcement bodies of the Russian Federation, Federal Service financial and budgetary supervision, Chamber of Accounts Of the Russian Federation and state authorities of the Russian Federation.

Security questions for section 5

1 What is the definition of licensing control?

2. What are the rights of persons authorized to conduct a license control audit?

3. The expiration of what period of time is the basis for including the institution in the plan for conducting scheduled inspections?

3. What documents are used to document the results of the license control audit?