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药品的厂方“负责期”是药品生产企业与药品经营企业为加强内部制约而制订的各自负责的期限。它与药品的“有效期”不同。“负责期”是行业性的,“有效期”是法制性的。凡超过有效期的药品,《药品管理法》规定为劣药。药品厂方“负责期”可以理解为:超过“负责期”的药品,厂方不承担主要经济责任。但是,“负责期”标示在药品的标签及包装上,易造成病人和医疗单位用药上的疑虑和困惑。在工作中经常遇到出厂5年以上的注射剂、片剂等还在使用。对于这些药品,如果作报废处理,法律法规没有明确的规定;如果任其使用,安全有效的科学依据不足,因此对这些药品的处理,感到十分棘手。为适应药品监督管理工作的需要,建议有关部门有必要根据各类药品在规定贮藏条件下的最长使用期限,作出明确的规定,并由药品生产企业明显地在药品标签及包装上标示。同时规定对经营,使用超过药品使用期限的罚则,以进一步确保药品的安全有效。
The “responsibility period” of the drug manufacturer is the period for which the drug manufacturer and the drug manufacturer are responsible for strengthening the internal control. It is different from the “expiration date” of the medicine. “Responsible period” is industry-based, and “expiration date” is legal. Where more than the validity of the drug, “Drug Administration” provides for inferior drugs. Drug manufacturers “responsible period” can be understood as: more than “responsible period” of the drug, the factory does not assume the primary economic responsibility. However, the “responsible period” is marked on the labels and packaging of medicines, which can easily lead to doubts and confusion on the part of patients and medical units. In the work often met the factory for more than 5 years of injection, tablets are still in use. For these drugs, if scrapped, laws and regulations do not have a clear rule; if they are used safely and effectively, there are not enough scientific evidences to deal with these medicines and they feel that it is very troublesome. In order to meet the needs of drug supervision and management work, it is suggested that the relevant departments need to make definite provisions according to the longest service life of all kinds of drugs under the specified storage conditions, and the pharmaceutical manufacturing enterprises are clearly marked on the labels and packaging of medicines. At the same time, it stipulates that penalties for the operation and use of drugs exceeding the expiry date of the drugs should be provided to further ensure the safety and effectiveness of the drugs.