"Drug use license" issued by the municipal health administrative department. Article V medical institutions to apply for a "Drug Use Permit" must have the following conditions:
(1) a valid certificate of approval to practice medicine by the health administrative department of the district (city) or above, and the consent of its competent department;
(2) with a pharmacy professional and technical personnel appropriate to the medical business or by the health administrative department of Qingdao City, the staff of the pharmacy technical assessment;
(3) the medical institution must obtain a "Drug Use Permit" by the health administrative department of Qingdao City, the city of Qingdao. /p>
(3) with the size of the medical business in line with the provisions of the pharmacy or medicine cabinet and storage, transfer, processing and concocting medicines necessary equipment and measuring instruments;
(4) have a sound and complete procurement, storage, use of drugs regulations. Article VI of the medical institutions to apply for "Drug Use License" in Laoshan District, Huangdao District and county-level cities, by the district (city) health administrative department for approval, issuance, and reported to the municipal health administrative department for the record; in the city's five districts, by the district health administrative department of the preliminary examination, reported to the municipal health administrative department for approval, issuance. Article VII of the medical institutions without the "Drug Use License", are not allowed to use drugs in medical practice.
Strictly prohibit the transfer, lending, buying and selling of "Drug Use License". Article VIII of the "Drug Use License" is valid for five years, after the expiration of the continued use of the licensee should be re-applied for within six months before the expiration of the unit. Drug Use Permit" is validated once a year by the approving authority, confirmed by the approving authority can be exempted.
Bankruptcy or closure of the medical institution, the "Drug Use License" should be returned to the original approval authority. Article IX of the medical institutions to purchase drugs should hold the "Drug Use Permit" to obtain the "Drug Business Enterprise License" unit of purchase. It is strictly prohibited to purchase drugs from units and individuals without "Drug Business Enterprise License", and it is strictly prohibited to buy and sell drugs without approval numbers, registered trademarks or brand names.
Drug business units shall not wholesale drugs to units without "Drug Use License". Article 10 of the medical institutions on the purchase of drugs should be established to purchase registration and quality inspection records, including goods number, source, name, specifications, quantity, origin, batch number, appearance and quality, etc., the records are kept for three years for inspection. Article XI of the medical institutions should be fully closed isolation of the pharmacy, and is equipped with the necessary facilities to achieve cleanliness and hygiene, the positioning of drugs, signs, drugs shall not be stored in the same room with veterinary drugs, pesticides, rodenticides, disinfectants, chemical reagents and other non-drugs. Article XII of the medical institutions in direct contact with the personnel of the drug, must be conducted once a year for health checkups, to obtain the municipal health administrative department issued a "health certificate" before being allowed to work. Suffer from infectious diseases or other diseases that may contaminate the drugs, personnel shall not engage in direct contact with the work of drugs. Article XIII of the medical institutions engaged in pharmacy technology, but no technical title of pharmacy personnel, must be qualified by the municipal health administrative department to receive the "qualification certificate from the pharmaceutical personnel," before continuing to engage in pharmacy technology. Article 14 The medicines used in medical institutions must comply with the Chinese People's **** and the State Pharmacopoeia, the Chinese People's **** and the State Ministry of Health Drug Standards, the provinces, autonomous regions, municipalities directly under the Central Government Drug Standards, and municipal health administrative departments approved the registration of quality standards, and strictly abide by the Chinese People's **** and the State Drug Administration Law and the relevant provisions of the Pharmaceutical Affairs Management. Article XV of the medical institutions to use drugs are prescribed by the unit's doctors, urban and rural health clinics or individual medical clinics are not set up pharmacy, should be set up to record the patient's medication record book. Prescription or medication record book kept for three years for inspection.
Medical institutions shall not sell medicines to patients who are not attending, shall not distribute non-pharmaceuticals, shall not be disguised as a medical treatment of drugs. Article XVI of the medical institutions to use narcotic drugs, psychotropic substances, toxic drugs and radioactive drugs, shall comply with the relevant state regulations on the management of special drugs. Article XVII of the medical institutions need to prepare their own preparations, must be in accordance with the "Chinese People's Republic of China * * * and the State Drug Administration Law," the provisions of the "Preparation License", no "Preparation License" of the medical unit, is strictly prohibited to process their own preparations. Formulation of special therapeutic effects, and the medical institutions do not have the processing conditions, by the municipal health administrative department to confirm the approval of the designated conditions of the medical institutions to process, and by the Qingdao Municipal Drug Inspection Laboratory after passing the test before being used in the clinic. Unauthorized production and use is strictly prohibited. Article 18 The medical institutions to develop new drugs should be in accordance with the "People's Republic of China *** and the State Drug Administration Law" and "Approval of New Drugs," the provisions of the approval procedures; unauthorized, may not conduct clinical trials or unauthorized expansion of the scope of clinical verification. Article 19 The medical institutions should strengthen the quality of drugs self-testing, control and management, the use of drugs responsible for the quality.