MDs control number 1
Category: "Pharmaceutical activities. Organization and regulation. "
1. Select the regulations pertaining to the pharmaceutical activities:
A) of the Federal Law "On Circulation of Medicines"
B) of the Federal Law "On securities market"
B) of the Federal Law "On Advertising"
D) of the Federal Law "On certification of products and services"
D) of the Federal Law "On Protection of Consumers' Rights
2. Normative acts of the federal subjects and local authorities:
A) Specify the applicable federal laws
B) take into account the specifics of the region
B) may be contrary to Law
D) can not contradict the Federal Law
3. Entrepreneurial activities may carry out:
A) commercial organizations
B) non-profit organizations
D) Only legal entities
4. Commercial organizations must be registered in one of the legal forms of activity:
A) the establishment of
B) an economic entity
B) economic partnership
D) consumer cooperative
D) Unitary Enterprise
E) Production Cooperative
5. Licensing of pharmaceutical activity is determined by the following legal acts:
a) the federal law "On Circulation of Medicines"
b) of the Federal Law "On licensing certain types of activities"
c) Regulation on licensing of medical activities
d) Regulation on licensing of pharmaceutical activities
d) Regulation on licensing the production of medicines
6. The set of established regulations on licensing specific types of activity requirements and conditions which the licensee is required to the implementation of the licensed activity is defined as:
a) the licensing procedure
b) the requirements and conditions
c) the licensed activities
d) the mandatory requirements and conditions
d) license requirements and conditions
7. The Ministry of Health and Social Development of the Russian Federation provides all functions except:
A) public policy
B) the licensing of pharmaceutical activities
B) legal regulation
8. In the hierarchy of regulations are fundamental:
A) Health Ministry orders
B) Decrees of the President
B) Federal laws
D) of local authorities
E) Decisions of the Government of the Russian Federation
9. The priorities of the national project "Health" include:
A) Primary Health Care
B) Development of general practice
B) The need for the reorganization of hospital care in order to reduce hospital stay
D) State support for introduction of modern medical technologies
D) Strengthening emergency services
10. The main activities of the health care reform are to:
A) Modernization, creation of a centralized model of CHI
B) Upholding the state guarantees the provision of medical assistance to the population
C) attracting additional sources of financing health care
D) Strengthening preventative health, the formation of public culture of healthy lifestyles, the formation of health passport for every inhabitant of the country
11. Determine the form of ownership and organizational-legal form of activity of the pharmacy organization, if the labor collective on the property right belongs to the 100% stake of the share capital and authorized capital is 85 thousand. Rubles.
12. The pharmacy "The Imaginary Invalid" preparing drugs for individual prescriptions and requirements attached to the pharmacy maternity hospital number 7, available on prescription, and the requirements of LPU pure alcohol 25%, 50%, 96.5% and drugs to be included in the State Register drug and is not included in it. The pharmacy is licensed for pharmaceutical activities. When checking the licensing authority inspector licensing requirements and conditions pharmacy was recommended to issue a license for the supply of ethyl alcohol. Why are given such a recommendation?
TASK 1. Examine the contents of the Federal Law "On Medicines" and compare it to the new federal law "On Circulation of Medicines"
Method of implementation: The workbook to make the content of the articles of the Federal Law on the rules of the wholesale and retail trade in medicines in the following form:
TASK 2. Differentiation of powers among levels of government Pharmaceutical Services
Methods of Using the new document setting change function Health Ministry (Government Decision of 20.08.2010 n 650 "On amendments to some acts of the Government of the Russian Federation in connection with adoption of the Federal Law
"On Circulation of Medicines"), fill in the table:
TASK 3. Licensing requirements and conditions.
Method of implementation: Using the provisions of the specific activities, compare the licensing requirements and conditions for the implementation of various activities in the field of medicines. The result is presented in the form of the table:
Task 4. Learn how to find a significant difference, to determine the advantages and disadvantages of the organizational-legal forms of legal entities
Method of implementation: using standard documents fill in the table with the characteristic of various organizational and legal forms of legal entities. get their advantages and disadvantages.
Task 5. To study the procedure for state registration of legal entities.
Methods of execution: On the basis of the Federal Law on State Registration of Legal Entities, make a list of the documents required for state registration of legal entities in case of: 1) creating them; 2) at their reorganization. In the workbook, make a table.
Task 6. The reorganization of the legal entity
Methods of execution: On the basis of the Civil Code and the Law on State and municipal enterprises describe the methods and procedure of reorganization, give you a well-known examples from the literature reorganization of legal entities in the pharmaceutical market.
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