Shijiazhuang City issued automatic drug production machine drug management regulations
Recently, some medical retail enterprises trial water new format, launched 24-hour automatic sale machine, the public purchased non-prescription drugs, only the mobile phone scan payment is paid, and the drug will be taken within a minute to meet the people’s 24-hour medication.
In order to encourage and regulate the development of new activities in our city, recently, the Municipal Market Supervision Bureau issued the "Shijiazhuang City Automatic Drug Machine Drug Management Regulations (Trial)", which clarified the relevant management items.
"Regulations" mainly applies to large public places such as the city, station, colleges, and commercial districts and other public places to engage in non-prescription drug business activities and supervision and management activities. It requires business enterprises to obtain "business license" according to law. Operating license "and registered or mainly office locations in the city’s jurisdiction. Using automated drug machine engaged in non-prescription drug business activities, it should be observed by law, regulations, rules, standards and norms to ensure the real, accurate, complete and duel of the whole process; set out the quantity of the local resident population, region, Traffic conditions, etc., follow the reasonable layout, facilitate the principles of the mass purchase. The venue placed in the automatic drug machine should avoid direct sunlight, rain, etc., and have the corresponding conditions and measures to ensure the quality of the exhibition. The place should be cleaned, external use, and the internal service is relatively separated, and the automatic drug machine and toxic The contaminated substance is disposed in the same place. The environment in the equipment should meet the requirements of the drug storage conditions. According to the temperature of the packaging, the drug is stored, and the specific temperature is not indicated on the package, and stored in accordance with the storage requirements specified in the Pharmacopoeia of the People’s Republic of China; the relative humidity of the storage drug is 35% ~ 75%. Temperature and humidity monitoring is true, complete, accurate and duel, and has alarm function.
Drugs operating with automated drugs should be uniformly purchased by drug retail chain enterprises with the automatic drug machine, establish real, complete, accurate and traceable records.
Automated drugs operated by drugs should provide consumers to provide sales credentials (or electronic tickets), credentials (small tickets) content cover the name (number, location), drug name, listing permit for the production of automatic drug machines. Some people (manufacturers), quantity, price, batch number, specifications, validity period, sales date, etc., and other content stipulated by the Pharmaceutical Supervision and Administration Department of the State Council, ensuring drugs.
The drugs for automated drug machines should have a complete packaging, label, and manual.
Do not take advantage of the drug instructions or lack of drug specification. Encourage video surveillance of automated drug machines, and the automatic sale process can be traced back. The prominent position of the automatic drug machine should be marked with the "Automatic Sale Machine Registration Form" and show the consumer and regulatory authorities using modern information technology. The county (city, district) market regulatory authorities shall, in accordance with the requirements of the local management, the automated drug machine is included in the annual supervision and inspection plan, strengthen the daily supervision, supervise the implementation of legal obligations, accept and verify the consumer complaint report, according to law Investigate the violations of laws and regulations.
(Reporter Jiao Li Li).