ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

of July 7, 2015 No. 419n

About approval of Administrative regulations on provision by executive bodies of subjects of the Russian Federation of the state service in licensing of pharmaceutical activities (except for the activities performed by the organizations of wholesale trade by medicines for medical application and the pharmaceutical organizations subordinated to federal executive bodies, the state academies of Sciences)

According to the Federal Law of July 27, 2010 No. 210-FZ "About the organization of provision of the state and municipal services" (The Russian Federation Code, 2010, No. 31, Art. 4179; 2011, No. 15, Art. 2038; No. 27, Art. 3873, 3880; No. 29, Art. 4291; No. 30, Art. 4587; No. 49, Art. 7061; 2012, No. 31, Art. 4322; 2013, No. 14, Art. 1651; No. 27, Art. 3477, Art. 3480; No. 30, Art. 4084; No. 51, Art. 6679; No. 52, Art. 6961, 7009; 2014, No. 26, Art. 3366; No. 30, Art. 4264; 2015, No. 1, the Art. 67, 72), the order of the Government of the Russian Federation of May 16, 2011 No. 373 "About development and approval of administrative regulations of execution of the state functions and administrative regulations of provision of the state services" (The Russian Federation Code, 2011, No. 22, Art. 3169; No. 35, Art. 5092; 2012, No. 28, Art. 3908; No. 36, Art. 4903; No. 50, Art. 7070; No. 52, Art. 7507; 2014, 5, of the Art. 506) I order to No.:

Approve the enclosed Administrative regulations on provision by executive bodies of subjects of the Russian Federation of the state service in licensing of pharmaceutical activities (except for the activities performed by the organizations of wholesale trade by medicines for medical application and the pharmaceutical organizations subordinated to federal executive bodies, the state academies of Sciences).

Approved by the Order of the Ministry of Health of the Russian Federation of July 7, 2015, No. 419n

Administrative regulations on provision by executive bodies of subjects of the Russian Federation of the state service in licensing of pharmaceutical activities (except for the activities performed by the organizations of wholesale trade by medicines for medical application and the pharmaceutical organizations subordinated to federal executive bodies, the state academies of Sciences)

I. General provisions

Subject of regulation of Administrative regulations

1. The administrative regulations (except for the activities performed by the organizations of wholesale trade by medicines for medical application and the pharmaceutical organizations subordinated to federal executive bodies, the state academies of Sciences) (further - Administrative regulations) determine procedure and the standard of provision of the state service in licensing of pharmaceutical activities by provision by executive bodies of subjects of the Russian Federation of the state service in licensing of pharmaceutical activities (further - the state service) the executive bodies of subjects of the Russian Federation performing delegated powers on licensing of pharmaceutical activities in the field of drug circulation for medical application (further respectively - the licensing body, pharmaceutical activities).

2. The pharmaceutical activities in the field of drug circulation for medical application (except for the activities performed by the organizations of wholesale trade by medicines for medical application and the pharmaceutical organizations subordinated to federal executive bodies, the state academies of Sciences) (further - pharmaceutical activities) performed by legal entities and individual entrepreneurs are subject to licensing within provision of the state service. As a part of pharmaceutical activities works are performed, the following services are rendered:

1) retail trade by medicines for medical application;

2) leave of medicines for medical application;

3) storage of medicines for medical application;

4) storage of medicines for medical application;

5) production of medicines for medical application;

6) transportation of medicines for medical application;

7) transportation of medicines for medical application.

Circle of applicants

3. Applicants on receipt of the state service (further - applicants) are:

1) legal entities (except for the organizations of wholesale trade by medicines for the medical application and the pharmaceutical organizations subordinated to federal executive bodies, the state academies of Sciences) and the individual entrepreneurs having intention to perform or performing pharmaceutical activities (further respectively - the license applicant, the licensee) or authorized representatives of specified persons;

2) the physical persons and legal entities which addressed for provision of data on the specific license for implementation of pharmaceutical activities (further - the license).

Requirements to procedure for informing on provision of the state service

4. Informing on procedure for provision of the state service is performed by the licensing body:

1) by means of placement of information, including on graphics of acceptance of applicants and phone numbers for reference (consultations) on the official Website of the licensing body, the Single portal of the state and municipal services (functions): www.gosuslugi.ru (further - the Single portal of the state and municipal services (functions));

2) at information stands in reception of the licensing body;

3) on phone numbers for reference.

5. At information stands of the licensing body and the following information materials and documents are posted on the official site of the licensing body:

1) information on procedure for provision of the state service, including information on the place of acceptance of applicants and the days and hours established for acceptance of applicants;

2) the list of the regulatory legal acts of the Russian Federation regulating provision of the state service;

3) the document form and statements used by the licensing body in the course of licensing of pharmaceutical activities;

4) the information necessary for filling of details of the order on money transfer for payment of the state fee, including the universal identifier of charges (UIC) provided by the Rules of specifying of information in details of orders on money transfer on account of payments in budget system of the Russian Federation approved by the order of the Ministry of Finance of the Russian Federation of November 12, 2013 No. 107n "About approval of Rules of specifying of information in details of orders on money transfer on account of payments in budget system of the Russian Federation" (it is registered by the Ministry of Justice of the Russian Federation on December 30, 2013, registration No. 30913) with the changes made by the order of the Ministry of Finance of the Russian Federation of October 30, 2014 No. 126n (No. 35053) is registered by the Ministry of Justice of the Russian Federation on December 2, 2014.

6. Information on the submitted applications, the course of consideration of documents and decision making on provision (refusal in provision) to the license for implementation of pharmaceutical activities (further - the license) and renewal (refusal in renewal) to the license shall be available to applicants and be posted on the official site of the licensing body.

7. Data on the course (stage) of acceptance by the licensing body of the decision on provision (refusal in provision) the license, renewal (refusal in renewal) licenses, conducting check of compliance of the license applicant (licensee) to licensed requirements when implementing pharmaceutical activities are posted on the official Website of the licensing body and, including, on the Single portal of the state and municipal services (functions).

8. The information relating to implementation of pharmaceutical activities, provided by parts 1 and 2 of article 21 of the Federal Law of May 4, 2011 No. 99-FZ "About licensing of separate types of activity" (The Russian Federation Code, 2011, No. 19, Art. 2716; No. 30, Art. 4590; No. 43, Art. 5971; No. 48, Art. 6728; 2012, No. 26, Art. 3446; No. 31, Art. 4322; 2013, No. 9, Art. 874; No. 27, Art. 3477; 2014, No. 30, Art. 4256; No. 42, of the Art. 5615), is posted on the official site of the licensing body and (or) at information stands in premises of the licensing body within 10 days from the date of:

1) official publication of the regulatory legal acts establishing mandatory requirements to licensing of pharmaceutical activities;

2) acceptances by the licensing body of the decision on provision, cancellation of the license, suspension, renewal of its action, and also renewal of the license;

3) receipts of data on liquidation of the legal entity or the termination of its activities as a result of reorganization, about the termination of activities by physical person as the individual entrepreneur;

4) introductions in legal force of the judgment about cancellation of the license.

II. Standard of provision of the state service

Name of the state service

9. The state service in licensing of pharmaceutical activities (except for the activities performed by the organizations of wholesale trade by the medicines and the pharmaceutical organizations subordinated to federal executive bodies, the state academies of Sciences).

The name of the executive body providing the state service

10. The state service is provided by authorized body of the executive authority of the subject of the Russian Federation.

Federal executive bodies, the address to which is necessary for provision of the state service,

11. The following federal executive bodies, the address to which is necessary for provision of the state service, participate in provision of the state service:

1) Federal Tax Service (FNS of Russia);

2) Federal Registration Service (Federal Registration Service);

3) the Federal Service in the field of consumer protection and wellbeing of the person (Rospotrebnadzor).

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