First, it is necessary to apply for business license, drug business license, medical device business license and drug business quality management standards.
Two, according to the provisions of article fifteenth of the drug administration law of People's Republic of China (PRC), the establishment of a pharmaceutical trading enterprise must meet the following conditions:
(1) having qualified pharmaceutical technicians according to law;
(2) Having business premises, equipment, storage facilities and sanitary environment suitable for the drugs handled;
(3) It has a quality management organization or personnel suitable for the drugs it deals in;
(4) Having rules and regulations to ensure the quality of drugs.
Three, the specific application materials are:
1. The original, photocopy and resume of the academic credentials of the legal representative, the person in charge of the enterprise and the person in charge of quality of the bidding enterprise;
2. The original and photocopy of the practicing certificate of licensed pharmacist;
3. The scope of drugs to be handled;
4. Proposed business premises, equipment, storage facilities and surrounding sanitary environment.
Extended data
Chen Hong (pseudonym), who lives in Guangze County, Fujian Province, is very worried about whether his pharmacy will open as usual next year. The reason for Chen Hong's headache is that the original GSP (good manufacturing practice) certification of pharmacies will expire on 65438+February 3 1 day, while the new GSP revised in 20 13 in China puts forward clear requirements for licensed pharmacists in pharmaceutical wholesale and retail respectively.
That is to say, "the person in charge of the quality of pharmaceutical wholesale enterprises should have a bachelor's degree or above, the qualification of licensed pharmacists and more than three years' experience in quality management of pharmaceutical business, and have the ability to correctly judge and ensure implementation in quality management" and "the legal representative or person in charge of pharmaceutical retail enterprises should have the qualification of licensed pharmacists".
Moreover, the Twelfth Five-Year Plan for National Drug Safety clearly stipulates that by the end of 20 15, each retail pharmacy should be equipped with at least one licensed pharmacist.
Baidu Encyclopedia-People's Republic of China (PRC) Drug Administration Law
People's Network —— The Trouble and Confusion of Small Pharmacy Operators