Can't add antibiotic in antibacterial preparation
It is reported (Reporter Yang JieSong Chen Fei) Ministry of Public Health prints and distributes " sterilizes the products hygiene safety evaluation regulation " recently. " the regulation " this suitable for, need, obtain the intersection of products and the intersection of disinfection and the intersection of products and the intersection of hygiene and safety evaluation merchandize for the first time, that hygiene permit. Involving the products includes the ultraviolet ray sterilization light, tableware sterilizer, pressure vaporized sterilizer, 75% the intersection of folk prescription and the intersection of ethanol and antiseptic, times of the intersection of chloric acid and sodium disinfectant and the intersection of fifth and 2 aldehyde the intersection of disinfectant and product, resist ' Restrain) Fungus preparation,etc..
" regulation " is pointed out, before and after sterilizing the products and going on the market, the accountability unit of the products did not need to be put on record to health authorities, but need to carry on the safety evaluation of the hygiene to the products, and is responsible for appraising the result. The safety evaluation content includes products label, manual, survey report, carries out the standard. Among them, disinfectant and resisting (restrain) Fungus preparation also includes the prescription of products, raw materials, sterilizing the apparatus should also include the structure chart of the products. Resist (restrain) Can't add antibiotic, resist fungi medicine and hormone in fungus preparation.
" regulation " is emphasized, product management, applying unit should ask for the hygiene licence of manufacturing enterprise and copy of " safe appraisal report of the hygiene " before managing, using and sterilizing the products, and the accountability unit of the products stamps an offical seal. The applying unit is checking " safe appraisal report of the hygiene " and selling the name which use the products actually, after information such as specification, dosage form, accountability unit, production unit, label manual agree, can manage and use. Health authorities are responsible for supervising and inspecting the products hygiene safety evaluation situation.
It is reported, Ministry of Public Health also printed and distributed " sterilizes the hygiene of manufacturing enterprise of the products and permits the regulation " recently, it is engaged in sterilizing production of the products, unit and individual packaged from January 1 next year stipulating, must apply to get " sterilizes the hygiene licence of manufacturing enterprise of the products " according to the requirement of this regulation. The licence validity of hygiene is 4 years, it is only limited to producing in permitting the range sterilizing the manufacturing enterprise of the products, can't change approved mode of production, production project, production classification, production technology, workshop overall arrangement without authorization.
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