Health, health, price, industry and commerce, quality supervision and other departments shall, in accordance with their respective responsibilities, is responsible for the supervision and management of the use of drugs and medical devices related work. Chapter II procurement, receipt and inspection of Article 5 The use of units should be from the drugs, medical equipment production or business qualifications of enterprises to purchase drugs, medical equipment. Purchase does not implement the approval number management of Chinese herbal medicines and medical devices do not implement the management of business licensing or filing except. Article 6 The use of units should be designated within the agency or personnel unified procurement of drugs, medical devices. Other organizations or personnel shall not purchase on their own. Article VII to bidding and procurement of drugs, medical equipment, the use of units should strictly implement the relevant provisions of the state and province, and accept the supervision of the drug supervision department and other relevant departments. Article VIII of the use of procurement of drugs, medical devices, should check, request the following information, and establish the procurement file:
(a) a copy of the drug production or business license and business license, medical device production or business license, the filing of certificates and a copy of the business license;
(b) a copy of the certificate of quality management standard for the manufacture of pharmaceuticals or business certification;
(c) the production and operation of medical devices. /p>
(c) medical device product registration certificate or a copy of the record certificate;
(d) imported drug registration certificate or a copy of the registration certificate of pharmaceutical products;
(e) drug test report, biological products batch issued certificate of conformity, a copy of medical device certificate of conformity;
(f) the original of the drug, medical device salesperson authorization and a copy of proof of identity.
Copies of the information specified in the preceding paragraph shall be stamped with the seal of the supplying enterprise. Article IX of the drugs, medical devices, the use of units should check and record the mode of transportation to meet the requirements, check the drugs, medical devices and accompanying counterparts single, ticket is consistent.
The need for refrigeration, freezing of medicines, medical devices to the arrival, the use of units should also check and record the transportation time, the temperature of the transport process records and other quality control conditions. Does not meet the temperature requirements, should be rejected. Article 10 The use of units to purchase drugs, drugs should be in accordance with the lot number batch by batch acceptance, and the establishment of a true and complete drug acceptance records. Drug acceptance records should contain the generic name of the drug, manufacturer, dosage form, specifications, production batch number, expiration date, approval number, supply unit, quantity, date of arrival and so on. Drug acceptance records should be signed by the acceptance. Acceptance of unqualified drugs should be handled in accordance with the procurement contract and relevant state regulations.
Using units to accept donations of medicines and emergency medicines transferred from other units, should be in accordance with the provisions of the preceding paragraph for acceptance and records. Article XI of the use of units purchased medical equipment, should be imported and acceptance, and the establishment of a true and complete acceptance of medical equipment records. Acceptance records shall contain the product name, specifications, models, quantities, production batch number, expiration date, manufacturer, supplier, relevant licensing or filing documents number, date of arrival, etc.; sterilized medical devices, should also record the date of sterilization or sterilization batch number. Acceptance records should be signed by the acceptance. Acceptance of unqualified medical devices, should be dealt with in accordance with the procurement contract and the relevant provisions of the state.
Using units to invite physicians to bring their own medical equipment, accept donations of medical equipment, should be in accordance with the preceding paragraph for inspection and record. Article XII of the drug acceptance record retention time shall not be less than 3 years. Drugs are valid for more than 3 years, the acceptance record is kept until 1 year after the expiration of the expiration date.
Medical equipment acceptance inspection records should be kept until the expiration of the period of use of medical equipment or 2 years after the termination of the use of 2 years. Large medical device acceptance inspection records should be kept until the expiration of the specified period of use of medical equipment or 5 years after the termination of use. Implantable medical devices acceptance records should be permanently stored. Chapter III storage, conservation, maintenance of Article XIII of the use of units of storage of drugs, medical devices, facilities, conditions, should be consistent with the drugs, medical devices, packaging labeling storage requirements and relevant state regulations. The use of the unit's pharmacy, should be in line with national and provincial standards for pharmacy management. Article XIV of the use of units should be stored medicines, medical devices, regular inspection of stored medicines, medical devices, temperature, humidity monitoring. Inspection, monitoring, shall be recorded.
The inspection found expired, expired, deteriorated, moldy, insect-infested, broken, out of drugs and expired, broken, expired, out of medical equipment, the use of units should be immediately sealed, registered, and in accordance with relevant provisions of the report, processing.