Doing business with herbs, the documents needed are "drug business license", to the location of the provincial, autonomous regions, municipalities directly under the Central People's Government of the drug supervision and management department for.
1, the opening of pharmaceutical wholesale enterprises, shall be approved by the enterprise location of the provincial, autonomous regions, municipalities directly under the Central People's Government of the drug supervision and management department and issued a "drug license";
The opening of pharmaceutical retail enterprises, shall be approved by the enterprise location of the county-level or above local drug supervision and management department and issued a "drug license". Those without a Drug Operation License are not allowed to operate drugs.?
"Drug business license" should be marked with the validity and scope of business, the expiration of the re-examination of the license. Drug supervision and management department to approve the opening of drug business enterprises, in addition to the conditions based on Article 15 of this Law, should also follow the principle of rational layout and convenience of the public to purchase drugs.
2, application acceptance process:
Application for the opening of drug retail (chain) enterprises to the Municipal Drug Administration, application for the opening of drug retail enterprises to the proposed enterprise location of the Drug Administration to submit an application for preparatory work (the opening of the retail (chain) enterprises, the need to specify the chain of the management system), and to submit the following application materials:
1) Drugs, medical equipment business License Management System enterprise side "enterprise preparatory application" (3.5-inch disk) (the applicant in the website to download the enterprise side of the program and correctly fill out, export);
2) the proposed legal representative of the enterprise, the person in charge of the enterprise's original certificate of academic qualifications, practice qualifications or titles, photocopies and biographical information;
3) the category and scope of drugs to be operated;
4) the proposed business premises, warehousing facilities, equipment (with a map of the geographic location of the proposed registered address, floor plan (indicating the area), and indicate the shortest travelable distance with the drug retailer); the proposed warehouse map of the geographic location of the map, floor plan (indicating the area, width, length, and height);
5) the opening of a retail (chain) enterprises. Should also be submitted to the stores belonging to the "Drug License", "Business License" copy as well as proof of assets;
6) self-assurance statement of the authenticity of the application materials, and the materials to make a commitment to bear legal responsibility for any false; such as the need to submit floppy disks, together with the loss of data files caused by viruses to be responsible for their own commitment;
7) Where the applicant enterprise Declaration of materials, the applicant is not the legal representative or person in charge of himself, the enterprise should submit two copies of the "power of attorney";
8) according to the order of the application materials to produce a directory.
Expanded Information:
Management of Pharmaceutical Enterprises
Article 14
To start a pharmaceutical wholesale enterprise, shall be approved by the drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the Central Government where the enterprise is located and issued the "Drug Business License"; to start a pharmaceutical retail enterprise, shall be approved by the drug supervision and management department of the place where the enterprise is located at or above the county level and issued the "Drug Business License". Without the "Drug Business License", shall not operate drugs. Drug License" should be marked with the expiration date and business scope, expiration re-examination of the license. Drug supervision and management department to approve the opening of drug business enterprises, in addition to the conditions stipulated in Article 15 of this Law, shall also follow the principle of rationalization and convenience of the public to purchase drugs.
Article 15
The opening of pharmaceutical enterprises must have the following conditions: (a) with the qualification of pharmacy technicians according to law; (b) with the operation of pharmaceutical products appropriate business premises, equipment, storage facilities, sanitation; (c) with the operation of pharmaceutical products appropriate quality management organization or personnel; (d) with a guarantee of the quality of pharmaceutical products operated by the regulatory system. Regulations.
Article 16
Pharmaceutical enterprises must operate drugs in accordance with the Code of Practice for the Quality Management of Pharmaceutical Business formulated by the Drug Administration under the State Council in accordance with this Law. Drug supervision and management department in accordance with the provisions of the drug business enterprises whether to meet the requirements of the "Drug Business Quality Management Standard" for certification; the certification of qualified, issued a certificate of authentication. Drug business quality management standard" specific implementation methods, implementation steps by the State Council drug supervision and management department.
Article 17
Pharmaceutical business enterprises to purchase drugs, must establish and implement the purchase inspection and acceptance system, inspection of drug certificates of conformity and other identification; does not meet the prescribed requirements, shall not be purchased.
Article 18
Pharmaceutical enterprises purchase and sale of drugs, there must be a true and complete purchase and sale records. Purchase and sale records must indicate the generic name of the drug, dosage form, specifications, batch number, expiration date, manufacturer, purchase (sale) unit, purchase (sale) quantity, purchase (sale) price, purchase (sale) date and the State Council drug supervision and management department of the other contents of the provisions.
Article 19
Pharmaceutical companies selling drugs must be accurate, and correctly explain the usage, dosage and precautions; allocation of prescriptions must be checked, and the drugs listed in the prescription shall not be changed without authorization or substitution. There are contraindications or excessive dosage of the prescription, should be refused to deploy; if necessary, by the prescribing physician to correct or re-signature, can be deployed. Drug companies selling Chinese herbal medicines, must be labeled with the place of origin.
Article 20
Pharmaceutical enterprises must develop and implement the drug storage system, to take the necessary refrigeration, anti-freezing, moisture-proof, insect-proof, rodent-proof and other measures to ensure the quality of drugs. Drugs into and out of storage must implement the inspection system.
Article 21
Chinese herbal medicines may be sold in urban and rural markets, except as otherwise provided by the State Council. Urban and rural bazaars and trade markets shall not sell medicines other than Chinese herbal medicines, but holders of the "Drug Business License" of the drug retail enterprises within the scope of the provisions of the urban and rural bazaars and trade markets can be set up to sell medicines other than Chinese herbal medicines. The specific measures shall be prescribed by the State Council.
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