2, industrial and commercial name and business license.
3, "Drug License", "Medical Device License", "Food License", GSP (drug quality management) certification.
Steps in the process of registering a pharmaceutical company:
Step one: make the preliminary preparations.
Preliminary preparations for the preparation of the main staff, including professional pharmacists, inspectors, custodians and so on; in addition to the preparation of hardware and equipment, such as stethoscopes and other necessary medical equipment, the preparation of these are costly and time-consuming.
The second step: apply for a pharmaceutical license.
The scope of medicine belongs to the pre-approval, so you can only apply for a business license after obtaining a drug license.
Currently there is no Pharmaceutical Affairs Bureau in China, the approval of the drug business enterprises, China's current law provides for two departments have the right to approve: first to the provincial Drug Administration, the application approval will be issued after the approval of the "drug business license".
The third step: apply for a business license.
Apply down the "drug business license" can only after the license to the Industrial and Commercial Bureau to apply for a pharmaceutical business license. Business license application and includes a lot of
steps, mainly the following: application, acceptance, approval, license.
Application for a business license need to prepare the following information:
Application for registration of pharmaceutical companies, legal representatives, shareholders and other proof of identity, registered address of the pharmaceutical company, the operator's license, business scope, pharmaceutical companies
Statute of Incorporation, the pharmaceutical company's registered capital and so on.
Submit the above information, after the Industrial and Commercial Bureau audit, you can get a pharmaceutical company business license.
The fourth step: GSP certification.
The Drug Administration Law stipulates that pharmaceutical companies must apply for GSP, or Good Manufacturing Practice certification, within one month of obtaining a pharmaceutical license from the provincial drug administration bureau.
The Drug Administration will generally organize the on-site certification of GSP in three months after receiving whoever applies for it. Only after obtaining the GSP certification, and in the absence of major drug quality incidents, the enterprise can be run for five years.
Legal basis:
"Chinese People's Republic of China*** and the State Drug Administration Law" Article 14 provides that the opening of pharmaceutical wholesale enterprises, subject to the approval of the people's government of the enterprise's provincial, autonomous regions and municipalities directly under the Central People's Government of the drug supervision and management departments and issued a "drug license"; the opening of pharmaceutical retail enterprises, subject to the approval of the enterprise's location by the county level Above the local drug supervision and management department for approval and issue of "drug business license". Without the "drug business license", shall not operate drugs.
"Drug license" should be marked with the expiration date and business scope, the expiration of the re-examination of the license.
Pharmaceutical supervision and management department to approve the opening of the drug business, in addition to the conditions stipulated in Article 15 of this Law, should also follow the principle of rationalization and convenience of the public to purchase drugs.
Article 15 of the Drug Administration Law of the People's Republic of China stipulates that the following conditions must be met in order to establish a drug business:
(1) a pharmacy technician qualified according to the law;
(2) a place of business, equipment, warehousing facilities, and sanitary environment suitable for the drugs to be operated;
(3) quality control appropriate for the drugs operated;
(3) the quality control of the drugs to be operated;
(4) the quality control of the drugs to be operated. (C) has with the operation of drugs appropriate quality management organization or personnel;
(D) has to ensure the quality of the drugs operated by the rules and regulations.