1. Purpose: In order to strengthen the company's drug management, reduce the number of drugs with near-expiration dates, reduce the losses caused by drugs with expiration dates, and improve the competitiveness of the company.

2. Basis: "Drug Administration Law of the People's Republic of China" and "Good Manufacturing Practices for Pharmaceutical Products".

3. Responsibilities: The Quality Management Department, Storage and Transportation Department, Purchasing Department, and Marketing Department are responsible for the implementation of this system.

4. Scope of application: Applicable to the management of the validity period of the drugs operated by this enterprise.

5. Distribution scope: Quality Management Department, Storage and Transportation Department, Purchasing Department, and Marketing Department.

6. Content:

The validity period of a drug refers to the period during which the drug can maintain its quality under specified storage conditions;

The validity period of the drug is determined by the drug manufacturer Only after the manufacturer has determined the drug stability test data and obtained approval from the drug regulatory department can it be marked on the packaging and label of the drug. It is one of the important identifications of the drug;

Purchased drugs must be exempted from national Unless otherwise specified, the validity period must be specified. The labeling format of the product's validity period is marked in the order of year, month, and day. The year is represented by four digits, and the month and day are represented by two digits. It is calculated and entered into the system. The specific labeling format is "valid until XXXXXXXX":

< p> Directly marking the expiration date as a certain month of a certain year means that the product will expire on the 1st of that month of that year. For example, a drug marked with "Expiration date: October 2018" will expire on October 1, 2018, and the system will enter the validity period as 20180930;

Directly marking the validity period in order of year and month means that the product is available to the last day of the year and month. For example, if a product is marked with "valid until October 2018", the product will be valid until October 31, 2018, and the system will enter the validity period as 20181031.

Indicate the validity period in years or months. The validity period of the product marked in this way can be calculated based on the production date of the product. For example, if it is marked with "production date 170815", the validity period is 2 years or 24 months, and its validity period is until 2019. On August 15, 2019, the system entered the validity period as 20190815.

Drugs should be marked with an expiration date. Those that do not indicate or change the expiration date will be treated as inferior drugs, and the acceptance personnel should refuse to accept them into the warehouse;

Special attention should be paid to the expiration date and appearance quality when accepting drugs. Drugs that do not meet the company's regulations are not allowed to be accepted into the warehouse. In order to control the validity period, products that do not meet the regulations must be verified by the quality management department before they can be purchased. When signing the contract, the purchasing personnel should clarify the regulations and availability of the validity period with the supplier. Return and exchange terms;

The definition of drugs with a near-validity period, drugs with a near-validity period are drugs that are close to the expiration date marked on the drug packaging label

9 months before the expiration date Defined as drugs with a near-validity period, they will be removed from the shelves in the next month after a warning of the near-validity period;

The enterprise computer system automatically tracks and controls the validity period of the drugs in stock, and takes early warning of the near-validity period and automatically moves the warehouse to Treatment

Legal basis

"Drug Administration Law of the People's Republic of China"

Article 2: Engagement in the territory of the People's Republic of China This law shall apply to drug development, production, operation, use and supervision and management activities. The term “drugs” as mentioned in this Law refers to substances used to prevent, treat, and diagnose human diseases, to purposefully regulate human physiological functions and have prescribed indications or functions, usage, and dosage, including traditional Chinese medicines, chemical drugs, and biological products. wait.

Article 3 Drug management should be centered on people’s health, adhere to the principles of risk management, full-process control, and social governance, establish a scientific and strict supervision and management system, comprehensively improve drug quality, and ensure drug safety. safe, effective and accessible.

Article 83: Drug marketing authorization holders shall regularly conduct post-marketing evaluations on the safety, effectiveness and quality controllability of marketed drugs. When necessary, the drug regulatory department of the State Council may order the drug marketing authorization holder to conduct post-marketing evaluation or directly organize to conduct post-marketing evaluation.

After evaluation, the drug registration certificate should be canceled for drugs that have inaccurate efficacy, severe adverse reactions, or are harmful to human health for other reasons.

Drugs whose drug registration certificates have been canceled shall not be produced or imported, sold or used.

Drugs whose drug registration certificates have been canceled or whose validity period has expired shall be supervised and destroyed by the drug regulatory department or other harmless treatment and other measures shall be taken in accordance with the law.