I don't know. Page3
A comprehensive drug knowledge test and answer
Department: name: score:
I. Filling out of the questions (1 minute per space, 20 minutes)
The current version of the pharmacy is divided into four sections, which will be officially implemented as of 1 december 2015。
2. Enterprises shall store medicines reasonably in accordance with their quality characteristics, and shall store them at the constant temperature of 10-30°c, at not more than 20°c, at the temperature of 2-10°c in cold storage, at the temperature of 2°c - 8°c in cold storage, and at the relative humidity of each warehouse at between 35°c and 75%。
It is not less than 5 cm for the meds and equipment of the facility, such as the interior wall, roof, temperature control equipment and plumbing, and 10 cm for the floor。
The content of the pharmaceutical component does not meet national standards and is a poor drug. If the production lot number is not indicated or changed, it shall be treated as bad medicine。
5. The import of medicines is subject to an organizational review by the drug supervisory authority of the state council, which confirms that it meets quality standards and is safe and effective, before it can be approved and a certificate of registration of imported medicines issued。
6. The state applies special regulations for narcotic drugs, psychotropic substances, toxic substances for medical purposes and radioactive substances. Management practices are developed by the state council。
7. Special drugs are subject to inspection, in addition to the normal drugs, of the special markings on their internal and overpacks, which are kept in a separate file for a period of one year or less。
8. The chinese pharmacology code, promulgated by the national drug control authority, is the drug code that the state has developed to guarantee the quality of medicines and the safety, effectiveness and control of the population。
Ii. Single topics (2 points per question, 20 points)
1. The establishment of wholesale and retail enterprises for drugs requires the acquisition of (b)a, pharmaceutical production permits b, pharmaceutical operating licences
C. Medical establishment agents licence d. Import permits
Conduct a health check. A, 5b, 3c, 2d, 1
Conduct a health check。
(d)
A. 5
B
C. 2
D
3. Drugs must be consistent with
(a)
A. National drug standards b. Provincial drug standards
C. Municipal drug standards d. Autonomous community drug standards
4. Refrigerated medicines are transported without direct access (d) to prevent any impact on their quality. A, ice bags b, ice caps
C. Insulation devices d. Refrigerants
5. For the production and sale of counterfeit medicines, the confiscation of medicines produced or sold in violation of the law and the proceeds obtained in violation of the law, and a fine of several times the value of the goods produced or sold in violation of the law (b)
A, less than two times b, less than two or more times five times
C, more than double and less than three times d, more than three times and less than five times
6. To order the correction of enterprises, enterprises or medical institutions that buy medicines from enterprises that do not have a pharmaceutical production licence or a pharmaceutical operating licence, to confiscate medicines purchased in violation of the law and to impose a fine of several times the value of the goods purchased in violation of the law (b)
A, less than two times b, less than two or more times five times
C, more than double and less than three times d, more than three times and less than five times
7. The current authorities in the country responsible for the supervision and management of national medicines are (d)a, the national medical administration b, the national drug administration
C. National drug supervisory authority d. National food and drug supervisory authority
The medicines control act provides that the production of medicines is subject to the approval of the state council's drug supervisory authority and is sent to (d)
A. Advertising approval symbol
B. Trademark registration number
C. Licensing of pharmaceutical production
D. Drugs approval symbol
Drugs whose approval documents have been withdrawn
(c)
A. Continued production and sale of b during the year, production and sale of c during the active period, exclusion from production and sale of d, destruction supervised by local health administration
10. The national drug standards (b)a, the drug regulatory authority b, the national drug board
C. China pharmaceutical biological products inspectorate d. Business administration
Iii. Multi-choice topics (3 points per question, 60 points)
1. Receiving and inspection officers shall examine and verify each sample of medicines (abcd) and the supporting documentation thereof。
A. Appearance b, packaging
Appearance
B. Packaging
C. Labels
D. Notes
2. Conditions for starting a pharmaceutical business
(abcd)
A. Pharmacological technicians qualified by law
C. Persons with a quality authority or person d appropriate to the drugs in which they are operated, regulations b to ensure the quality of the drugs in which they are operated, business premises to accommodate the drugs in which they are operated, equipment, storage facilities, health environment
C. Quality management agencies or personnel appropriate to the drugs they operate
D. Regulations to ensure the quality of medicines operated
B. Having a place of business, equipment, storage facilities, health environment appropriate to the drugs in operation
3. Packaging of medicines shall be printed or labelled and accompanied by instructions, as prescribed. The label or description must indicate (abcd)a, generic name of the drug, composition, specifications, production company b, approval number, product lot number, date of production, validity c, suitability or functional management of the drug, usage, quantity, taboo, adverse reaction d, note of the drug,4 which of the following medicines must bear the prescribed label (abe) a, external drugs b, non-prescriptive drugs c, prescription d, state priced medicine e, special management of medicines, head of the medical institution in which the drug is used by the manufacturer, operator or agent of the drug, purchaser of the drug, physician of the drug, etc., shall be held criminally responsible for the drug production, operation and medical treatment of the drug in question in accordance with the law
3. Packaging of medicines shall be printed or labelled and accompanied by instructions, as prescribed. The label or instructions must be noted
(abcd)
A. Common names, ingredients, specifications, manufacturers of medicines
B. Approval number, product number, date of production, period of validity
C. Adaptive or functional treatment of medicines, usage, quantity, taboos, adverse effects
D. Physicidal care
4. Which of the following medicines shall be labelled with the required markings
(abe)
A. External drugs
B. Non-prescription drugs
C. Prescription drugs
D. National pricing of medicines
E. Specially managed medicines
5. The head of the medical institution in which the drug is used, the director of the enterprise, the operator or his representative
Penalties relating to property or other interests of persons involved in drug procurement, physicians, etc. Package
(cde)
A. Warning
B, fine from $10,000 to $200,000
C. Confiscation of proceeds of crime
D. Under aggravating circumstances, the licence of a pharmaceutical production company or a pharmaceutical company is revoked and the drug supervision is notified
Departmental revocation of pharmaceutical production licences, drug operating licences
E. Criminal liability for constituting an offence
6. The pharmaceutical production, operation and medical units should regularly visit their own medicines
(abc)
A. Quality
B. Effects
C. Adverse effects
D. Market conditions
E. Economic benefits
7. Drug production, business operations, drug non-clinical research institutions, drug clinical testing institutions not implementing the required quality
(abde)
A. Warning
C. Confiscation of the proceeds of an offence d
C. Confiscation of proceeds of crime
D. If it is overdue, order the suspension of production, the liquidation of the business and a fine of between $5,000 and $20,000
E. Under aggravating circumstances, withdrawal of pharmaceutical production licences, drug operating licences and drug clinical trials
Eligibility
8. The law of the people's republic of china on the regulation of medicines provides for national pharmaceutical standards, including:
(ad)
A. Pharmacy of the people's republic of china
B. Provincial drug standards
C. Municipal drug standards
D. Drug standards issued by the drug regulatory authority of the state council
E. Enterprise drug standards
The purpose of the drug control act
(abde)
A. Strengthening drug surveillance and management
B. Ensuring the quality of medicines
C. Improving the efficacy of medicines
D. Ensuring the safety of human medicines
E
Protecting the health of the population and the legitimate rights and interests of drug users
10
B. Corrections of regulations
(abcde)
A
It has to meet medical requirements
B
Standards to protect human health and safety must be met
C. Approval of d by the drug regulatory authority in connection with the approval of medicines, prohibition of the use of e without authorization, requirements that must be adapted to the quality of medicines, compliance with the requirements for the regulation of drug advertising (abcde) a, non-scientific assertions of efficacy in drug advertising or assurance of b, prohibition of the use of state bodies, medical research and research units, academic institutions or experts, scholars, physicians, patients ' names and images c, prohibition of the publication of prescription drugs in the mass media, prohibition of non-pharmaceutical advertising in connection with medicines e, subject to review and approval by the provincial drug supervisory authority
C. Approval of medicines by the drug regulatory authority
D. Non-use without authorization
E. Requirement to fit the quality of medicines
11: conformity with the regulation of drug advertising
(abcde)
A. Advertising medicines shall not contain unscientific assertions or assurances of efficacy
B. No use shall be made of the names of state organs, medical research units, academic institutions or experts, academics, physicians, patients
Proof of meaning and image
C. Non-advertising of prescription drugs in the mass media
D. Non-pharmaceutical advertising should not involve drug propaganda
E. Advertisement of medicines subject to review and approval by provincial drug supervision authorities
12. Penalties for unauthorized production of drugs, dealing in drugs or preparations without a licence
(abce)
A. Suppression by law
C. A fine of two to five times the value of the medicines produced or sold in violation of the law d, the competent officer or other persons directly responsible for them not to engage in the production, operation and operation of medicines for a period of 10 years, which constitutes an offence, criminal liability under the law 13, the administrative penalties for the sale of ill medicines are (abcde) a, the confiscation of medicines and proceeds of crime b, and a fine of up to two to three times the value of drugs sold in violation of the law c, in serious cases, the suspension of production, the suspension or withdrawal of the certificate of approval of medicines, the revocation of the licence to manufacture medicines, the licence to operate medicines or the licence to produce medical institutions d, the company or other unit under serious circumstances, the competent officer or other person directly responsible for the production of bad medicines for a period of 10 years, the administrative penalty for the seizure of the materials, packaging materials and equipment used by the producer solely for the production of bad medicines, and the penalty of imprisonment, knowing or being aware of the conditions for their transport, safekeeping, storage, etc
C. Fine of two to five times the value of medicines produced or sold in violation of the law
D. Designated officials and other persons directly responsible shall not engage in the production or operation of drugs for 10 years
E. Criminal liability for constituting an offence
13
(abcde)
A. Confiscation of medicines and proceeds of crime
B. A fine of more than double or triple the value of medicines sold illegally
C. In serious cases, the suspension of production, rehabilitation or revocation of the certificate of approval of the drug
