The relevant departments of governments at all levels shall do a good job in the supervision and management of drugs and medical devices within their respective responsibilities. Article 4 When purchasing raw materials and pharmaceutical excipients with drug approval numbers (hereinafter referred to as pharmaceutical excipients), pharmaceutical production enterprises shall obtain the following documents from suppliers and keep them for one year after the expiration of the validity period of raw materials and pharmaceutical excipients. If the validity period is less than two years, it shall be kept for three years:
(1) A copy of the Pharmaceutical Production License or Pharmaceutical Business License stamped with the original seal of the supplier;
(2) A copy of the business license stamped with the original seal of the supplier;
(3) A copy of the certificate of good manufacturing practice or good manufacturing practice with the original seal of the supplier;
(4) Power of attorney signed or sealed by the legal representative of the supplier (the power of attorney shall specify the variety, area and time limit of authorized sales, and indicate the ID number of the salesperson; If the power of attorney is a copy, it shall be stamped with the original seal of the supplier and the original seal or signature of the legal representative of the enterprise);
(five) a copy of the identity card of the salesperson;
(six) a copy of the approval certificate of the drug sold with the original seal of the supplier;
(seven) drug quality certificate, inspection report and drug purchase invoice;
(eight) other relevant documents that should be obtained according to law. Article 5 A pharmaceutical production enterprise shall not commit any of the following acts when producing drugs or preparing preparations by medical institutions:
(1) Purchasing raw materials and pharmaceutical excipients from enterprises that never have the qualifications for pharmaceutical production and wholesale;
(two) the use of raw materials and pharmaceutical excipients that should be marked but not marked with the expiration date or beyond the expiration date;
(three) raw materials and pharmaceutical excipients that do not meet the requirements of laws, regulations and national mandatory standards are put into production;
(four) the use of raw materials and pharmaceutical excipients that should be approved but not approved. Article 6 Pharmaceutical production enterprises must feed materials according to the prescription ingredients and prescription quantity stipulated in the national drug standards, and produce drugs according to the production technology approved by the state food and drug supervision and administration department. Article 7 Drugs produced by pharmaceutical production enterprises must pass inspection before leaving the factory.
Pharmaceutical production enterprises shall not forge inspection reports and other drug conformity certificates. Article 8 A pharmaceutical trading enterprise shall not commit any of the following acts:
(1) Purchasing drugs from drug retail enterprises;
(2) Purchasing and selling preparations from medical institutions;
(3) changing the mode of drug business without authorization;
(4) dealing in drugs beyond the scope of drug business license;
(five) placing goods other than drugs on drug counters and drug shelves;
(6) A drug retail enterprise rents or lends a Drug Business License and places the same drug on different counters or shelves in the business premises;
(7) Giving away prescription drugs or Class A over-the-counter drugs in various ways. Article 9 The tools used by drug retail enterprises for repackaging and selling drugs shall be complete, clean and hygienic. When selling drugs, the drug name, specifications, batch number, administration method, dosage, expiration date and other contents shall be indicated on the drug packaging bag. Article 10 Pharmaceutical production enterprises and wholesale enterprises shall not sell pharmaceuticals to units or individuals without a Pharmaceutical Production License, a Pharmaceutical Trading License and a Medical Institution Practice License.
Pharmaceutical production and trading enterprises shall not store or sell drugs outside the places approved by the food and drug supervision and administration department. Article 11 No unit or individual may sell or import drugs that should be inspected or approved according to regulations without inspection or approval. Article 12 pharmaceutical production and marketing enterprises shall report to the food and drug supervision and administration department seven days before purchasing expired drugs, and conduct it under the supervision of the food and drug supervision and administration department.
Illegal purchase of drugs is prohibited. Article 13 When purchasing raw materials or auxiliary materials for the production of medical devices subject to license management, medical device manufacturers shall obtain the following documents from suppliers:
(1) A copy of the business license stamped with the original seal of the supplier;
(2) Product quality certificate and purchase invoice.
If the raw materials or auxiliary materials belong to medical devices subject to license management and conform to the provisions of the preceding paragraph, a copy of the Medical Device Manufacturing Enterprise License or the Medical Device Trading Enterprise License stamped with the original seal of the supplier and a copy of the Medical Device Registration Certificate stamped with the original seal of the supplier shall also be obtained.
If the above-mentioned raw materials or auxiliary materials belong to aseptic products, the certification documents shall be kept until one year after the expiration of the validity period of the products; If there is no expiration date, it shall be kept until three years after the product is sold or stopped selling; If it belongs to the key products such as implants and interventional bodies stipulated by the state, the certification documents shall be kept permanently.