(a) have to ensure the quality of the drugs operated by the rules and regulations;
(b) with the qualification of pharmacy technicians in accordance with the law (the personnel requirements of a separate paragraph to be expanded).
(c) enterprises, legal representatives, business leaders, quality leaders without the Drug Administration Law, Article 75, Article 82 of the circumstances;
(d) with the business premises, equipment, warehousing facilities and sanitary environment suitable for the operation of drugs. Where a retail pharmacy is set up within a supermarket or other commercial enterprise, it must have an independent area
(v) have the ability to equip itself with the medicines needed to meet the needs of local consumers, and be able to guarantee a 24-hour supply. Drug retailers should have the number of varieties of essential drugs by the provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration in conjunction with the local situation to determine. The state on the operation of narcotic drugs, psychotropic drugs, medical toxicity 5/12 biological products otherwise provided for, from its provisions.
That is, to expand the second point above: the operation of prescription drugs, Class A non-prescription drugs, drug retailers, must be equipped with a licensed pharmacist or other qualified pharmacy technicians according to law. The person in charge of quality should be more than one year (including one year) experience in quality management of drug business. Drug retail enterprises operating Class B non-prescription drugs, as well as rural townships below the establishment of drug retail enterprises, should be in accordance with the provisions of Article 15 of the "Regulations for the Implementation of the Drug Administration Law" with business personnel, and conditions should be equipped with licensed pharmacists. Enterprise business hours, the above personnel should be on duty.
Pharmaceutical license business scope:
According to the "Drug License Management Measures" Article 7 of the approval of the business scope of pharmaceutical enterprises.
1, narcotic drugs, psychotropic substances, toxic drugs for medical use;
2, biological products;
3, Chinese herbal medicines, Chinese medicinal herbs, Chinese medicinal tablets, proprietary Chinese medicines, chemical raw materials and their preparations, antibiotic raw materials and their preparations, biochemical drugs.
4, engaged in the retail sale of drugs, should be approved first business category, to determine the applicant's qualifications to operate prescription drugs or non-prescription drugs, Class B non-prescription drugs, and to be clear in the scope of business, and then approved the specific scope of business.
5, medical toxic drugs, narcotic drugs, psychotropic drugs, radiopharmaceuticals and preventive biological products approved in accordance with the national management of special drugs and preventive biological products management of the relevant provisions of the implementation.