The application of traditional techniques for the production of Chinese medicinal products should be configured by the medical institutions according to law.

Medical institutions configured to apply the traditional process of production of Chinese medicinal varieties should be in accordance with the law to the medical institutions of the provincial, autonomous regions, municipalities directly under the Central People's Government of the People's Government of the drug supervision and management department for the record can be dispensed, do not need to obtain the preparation of the approval number.

I, the definition and classification of Chinese medicine preparation

Chinese medicine preparation refers to the Chinese herbal medicine as raw materials, in accordance with the theory of traditional Chinese medicine and technical requirements, after processing, preparation and become a drug. According to the nature and use of the preparation, it can be divided into prescription drugs, non-prescription drugs and in vitro diagnostic reagents.

Two, medical institutions to configure the provisions of Chinese medicine preparations

1, medical institutions should comply with the relevant national laws and regulations on drug management, establish and improve the management system of Chinese medicine preparations, to ensure the quality and safety of Chinese medicine preparations.

2, the medical institutions configuration of Chinese medicine preparation, should have with the preparation of varieties, scale of facilities, equipment and professional and technical personnel.

3, medical institutions should be configured to the quality of Chinese medicine preparations for quality inspection to ensure compliance with relevant quality standards.

Third, violation of the provisions of the treatment measures

For failure to follow the provisions of the record, unauthorized changes in the preparation process, substandard quality or other violations of the provisions of the management of Chinese medicinal preparations of medical institutions, drug supervision and management authorities have the right to order correction, warnings, fines and other penalties. Serious violations, according to law, revocation of the "medical institutions license".

Related regulations and process of filing

1, the specific process of filing

Medical institutions in the configuration of the application of traditional techniques for the production of Chinese medicinal preparations, in accordance with the provisions of the drug supervision and management department of the province, autonomous region and province-level municipality directly under the central government for the record. The filing process includes the submission of relevant information, audit, approval and other links. The specific process can refer to the State Drug Administration issued the relevant provisions and guidelines.

2, the record required information

Medical institutions in the record need to submit a series of relevant information, such as preparation prescriptions, production processes, quality standards, instructions and so on. This information should meet the requirements of relevant regulations and standards to ensure the safety and efficacy of the preparation.

3. Management after filing

After obtaining the filing number, the medical institution shall carry out the production and quality management of the preparation in accordance with the relevant regulations. At the same time, the drug supervision and management department will supervise and inspect the filed preparation to ensure that the quality of the preparation meets the requirements.