I. Scope of filing procurement of drugs
All the drugs outside the catalog of the winning drugs and outside the catalog of the medical institution's own purchasing are subject to filing procurement.
Second, the record procurement of drugs procedures
1, the hospital clinical departments to apply;
2, the hospital pharmacy review;
3, the hospital pharmacy committee review;
4, bidding agencies to summarize the report, and to provide the same kind of winning products;
5, the city of centralized bidding for drugs purchasing management committee expert group Audit;
6, the audit opinion reported to the Municipal Drug Bidding Management Office;
Third, the record procurement of drugs, should be strictly controlled in its quantity. Correctly fill out the medical institutions drug filing procurement form, and provide the following information and drug description.
(a), apply for record procurement, direct distribution of drug manufacturers
Comprehensive documents
1, business license;
2, drug production license;
3, authorization letter of the legal representative;
4, the quality of medicines and distribution of the letter of commitment;
5, the enterprise agent's ID card;
6. Drug price confirmation form.
Product Documents
1, GMP certificate of drug manufacturing enterprise;
2, approval number of varieties, specifications and dosage forms agreed to be manufactured by the State Drug Administration;
3, proof of the quality internal control standards of the manufacturing enterprise [national standards, higher than national standards];
4, documents proving the patent protection period of patented drugs;
5, documents proving the original quality and distribution commitment of the original drug;
6, confirmation of the price confirmation form. p>
5, the original development enterprise drug development certificate;
6, national new drug certificate;
7, the latest minimum packaging unit of the drug samples or samples of color photos.
(2), the application for filing procurement, drug business enterprise distribution
Comprehensive documents
1, business license;
2, drug business enterprise license;
3, legal representative of the authorization letter;
4, the drug business enterprise GSP certificate;
5, the statement of qualifications of the drug business enterprise;
6, drug quality and distribution commitment;
7, enterprise agent's ID card,
8, drug price confirmation form;
Drug business enterprises to accept the manufacturer's drugs comprehensive documents
1, authorization letter of the manufacturer;
2, the manufacturer's business license;
3, the drug production Enterprise license;
Drug business enterprises to accept the production of each product specification documents
1, the production company's "instructions for the elements of drug varieties";
2, GMP certificate of drug manufacturers;
3, the State Drug Administration agreed to the production of the varieties, specifications, dosage forms of the approval number;
4, the production enterprise Proof of quality internal control standards [national standards, higher than the national standards];
5, patent protection period of patented drugs and Chinese medicine protection certificate;
6, the original development of the enterprise's drug development certificate;
7, the national new drug certificate;
8, samples of the latest smallest packaging unit of the drug or samples of the color photographs.
(C), the application for record procurement, imported drugs distributed by a first-class agent
Comprehensive documents
1, business license;
2, drug business enterprise license;
3, authorization letter of the legal representative;
4, statement of qualifications of drug business enterprises;
5, the quality of the drug and distribution Commitment;
6, enterprise agent's ID card,;
7, drug price confirmation form;
Product Documents
1, "Imported Drugs Variety Element Specification";
2, GmP certificate or GSP certificate:
3, imported drug manufacturers and the domestic first-class agent's agreement;
4, registration certificate of imported drugs;
5, port inspection report;
6, import license for sub-assembled drugs;
7, proof of the quality of internal control standards of the manufacturer;
8, patent protection period of patented drugs documents;
9, the original development of the enterprise's drug development certificates;
10, the bidding drugs The latest minimum packaging unit of the sample color photographs.
(D), apply for record procurement, imported drugs first-class agent commissioned by the business enterprise distribution
acceptance of the commissioned business enterprise's comprehensive documents
1, business license;
2, drug business enterprise license;
3, legal representative of the authorization;
4, drug business enterprise GSP certificate;
5, drug business enterprise qualification statement;
6, drug quality and distribution commitment;
7, enterprise agent's ID card,
8, drug price confirmation form;
Drug business enterprises to accept imported medicines first-class agent drug comprehensive documents
1, authorization of the manufacturer;
2, Manufacturer's business license;
3, the drug manufacturer's license;
Pharmaceutical business enterprises to accept imported medicines first-class agents of each product specification documents
1, "Imported Drugs Variety Element Specification";
2, GSP certificate.
3, imported drugs manufacturers and domestic first-class agents of the agreement;
4, imported drugs registration certificate;
5, port inspection report;
6, imported sub-assembled drugs license;
7, proof of the quality of the manufacturer's internal control standards; (higher than the national standard, the national standard)
8, patents Documentary evidence of the patent protection period of drugs;
9, the original development of the enterprise drug development certificate;
10, the latest minimum packaging unit of the drug samples or samples of color photos.
(E), instructions
1, the distributor is a drug manufacturer, but its contract drugs are not produced by the enterprise, should provide the commissioned processing approval documents and commissioned processing enterprise qualification documents;
2, the documents are uniformly bound in A4 paper.
3. All paper supporting documents must be stamped with a red seal.