The first camp information
One, the manufacturer:
1, enterprise legal person business license;
2, drug production license;
3, GMP (Good Manufacturing Practices, that is, Good Manufacturing Practices)
4, the Chinese people's **** and state Organization code;
5, tax registration certificate;
6, annual tax statement;
7, enterprise quality situation questionnaire;
8, quality assurance agreement.
Two, product materials:
7, product production approval (or drug registration certificate);
8, product inspection reports (the most recent provincial inspection, generally required within 2 years);
9, product price documents (health insurance products need to be the district price);
10, the product patent certificate documents (with the provision of the absence of this item to omit);
11, trademarks, trademarks, trademarks and other trademarks. p>
11, trademark documents;
12, each batch of product inspection reports (factory inspection, the first camp sampling used);
13, the minimum product box (sample);
14, copies of drug instructions;
15, general taxpayer certification records (with or without);
16, the legal person's authorization (legal person) Power of attorney);
17, a copy of ID card;
18, product production standards;
19, purchase and sales contracts;
20, product packaging and instructions for the approval of the internal and external;
21, qualification certificates of the purchasing and selling staff.
Three, the pharmaceutical company's first information:
1, enterprise legal person business license;
2, drug license
3, tax registration certificate;
4, the Chinese people *** and state organization code;
5, GSP (Good Supplying Practice);
6, the account opening certificate;
7, the company's first information:
8, the company's first information:
9, the company's first information:
10, the company's first information:
6, account opening license;
7, bank transfer account number (invoicing unit name, taxpayer identification number, address, telephone, bank account and account number);
8, supplier quality assurance system questionnaire;
9, quality assurance agreement.
Expanded Information:
"Drug license" should indicate the validity and scope of business, 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 set out in Article 15 of this Law, should also follow the principle of rationalization and convenience of the public to purchase drugs.
Article 15 The following conditions must be met in order to open a pharmaceutical enterprise:
(1) a qualified pharmacy technician in accordance with the law;
(2) a place of business, equipment, warehousing facilities, sanitation and hygiene environment appropriate to the operation of the drug;
(3) a quality management organization or personnel appropriate to the operation of the drug;
(4) a quality management organization or personnel;
(5) a quality control organization or personnel;
(6) a quality control organization or personnel appropriate to the operation of the drug. /p>
(D) has to ensure that the quality of the drugs operated by the rules and regulations.
Article 16 Drug business enterprises must operate drugs in accordance with the "Drug Business Quality Management Standards" formulated by the drug supervision and management department of the State Council in accordance with this Law. The 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; on the certification of qualified, issued a certificate of authentication.
The Specification for the Quality Management of Pharmaceutical Business, the specific implementation methods, implementation steps by the State Council drug supervision and management department.
Article XVII of the drug 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 of the drug business 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 regulations.
Article 19 of the drug business enterprise sales of drugs must be accurate, and correctly explain the usage, dosage and precautions; allocation of prescriptions must be verified, the prescription of the drugs listed in the unauthorized change 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.
Pharmaceutical companies selling Chinese herbal medicines, must be labeled with the place of origin.
Article 20 of the drug business enterprises must formulate 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 in and out of storage must implement the inspection system.
Baidu Encyclopedia - First Camp Information