(a) drug production enterprises production, quality management, equipment care, packaging, storage, acceptance, sales and other positions in direct contact with the staff of drugs;
(b) drug business enterprises purchasing, inspection, acceptance, storage, maintenance, quality control, deployment, sales and other positions in direct contact with the staff of drugs. Staff;
(c) medical institutions, drug procurement, acceptance, storage, maintenance, deployment, use, preparation and other positions in direct contact with drugs;
(d) medical device production, management enterprises and medical institutions in direct contact with the one-time use of sterile medical devices;
(e) direct contact with packaging materials and containers of drugs (e) direct contact with the packaging materials and containers of drugs, production operations, quality management, equipment care, sales, supply and other positions in the production enterprise staff.
The above personnel shall be allowed to work after passing the inspection and obtaining health certificates. The inspection of unqualified personnel, should be promptly transferred from work. Article 5 Medical institutions or disease control agencies with the following conditions can undertake the health inspection of staff in direct contact with medicines:
(1) have a "license to practice in medical institutions" containing a health inspection program or have the qualification of preventive health inspection;
(2) have a legal personality, able to independently assume civil liability;
(3) have a health inspection with the (C) has with the health examination appropriate examination, laboratory site, facilities and equipment and sanitary conditions;
(D) has the attending physician, supervising technician or the corresponding title of professional and technical personnel;
(E) has a perfect health examination system. Article VI of the Drug Administration in accordance with the rational layout, the principle of convenient inspection, from the units with the conditions set out in Article 5, selected on the basis of merit to undertake health inspections of the organization. Article 7 The institution undertaking the health examination shall comply with the following provisions:
(1) to carry out the examination in accordance with the prescribed examination items, and issue the true examination results, and within 10 days of the results of the examination will be notified in writing to the health examination of the person's unit and the local drug supervision and management department;
(2) the use of the unified supervision and management of the municipal drug supervision and management department of the "pharmaceutical staff health checklist";
(3) the use of the city drug supervision and management department of the unified supervision and management of the "pharmaceutical staff health Checklist";
(3) charge the health examination fee according to the fee standard stipulated by the price department;
(4) accept and cooperate with the supervision and inspection of the drug supervision and management department;
(5) other matters stipulated by laws, regulations and rules. Article 8 The staff in direct contact with drugs at least once a year for health checks. In case of public **** health emergencies and other special circumstances, the city drug supervision and management department can appropriately increase the frequency of health checks. Article IX general health examination includes the following items:
(a) liver function;
(b) stool culture;
(c) chest X-ray;
(d) skin signs;
(e) drug quality inspection, acceptance, maintenance of the staff of visual acuity and color recognition.
The municipal drug supervision and management department shall, in accordance with the national catalog of infectious diseases announced, the need for emergency public **** health emergencies, timely adjustment of the health examination program, reported to the municipal people's government agreed to be published and implemented. Article 10 confirmed by the health examination organization suffering from viral hepatitis, typhoid fever, paratyphoid fever, bacterial and amoebic dysentery, tuberculosis, exudative or suppurative skin diseases, shall not be engaged in direct contact with medicines, packaging materials and containers of medicines, single-use sterile medical devices.
Failure of color discrimination examination or corrected visual acuity of 1.0 or less, shall not be engaged in drug quality inspection, acceptance, maintenance work. Article 11 The health examiner has objections to the results of the health examination, may, within 7 days from the date of receipt of the results of the health examination to the original institution undertaking the health examination to apply for re-examination. The original institution undertaking the health examination shall accept the application in a timely manner and make a conclusion on the re-examination within 15 days. Article XII suffering from typhoid fever, paratyphoid fever, bacterial and amoebic dysentery and other infectious diseases of the personnel after treatment and recovery, their units should be allowed to return to their original positions and inform the health inspection agency and drug supervision and management departments. Article 13 The staff in direct contact with drugs have the following rights of health examination:
(1) to request their units to organize health examination;
(2) qualified health examination, you can ask their units to arrange for work;
(3) access to the health examination education, training and prevention of infectious diseases;
(4) participate in the work of their unit of (d) Participate in the democratic management of the work of the health examination;
(e) Report and charge violations of the health examination regulations.