The varieties of Chinese medicines applying for patents shall be handled in accordance with the provisions of the Patent Law, and these Regulations shall not apply. Article 3 The State encourages the research and development of clinically effective varieties of traditional Chinese medicine, and implements a graded protection system for varieties of traditional Chinese medicine with stable quality and definite curative effect. Article 4 The drug supervision and administration department of the State Council shall be responsible for the supervision and administration of the protection of varieties of traditional Chinese medicines throughout the country. Chapter ii classification and approval of protected varieties of traditional Chinese medicine article 5 the varieties of traditional Chinese medicine protected by these regulations must be those listed in the national drug standards. Varieties that have been determined by the drug supervision and administration department of the State Council as the drug standards of provinces, autonomous regions and municipalities directly under the Central Government may also apply for protection.
Traditional Chinese medicine protection varieties are divided into grade one and grade two. Article 6 Traditional Chinese medicine varieties that meet one of the following conditions may apply for first-class protection:
(a) has a special effect on specific diseases;
(2) Artificial products equivalent to the national first-class protection of wild medicinal species;
(3) It is used for preventing and treating special diseases. Article 7 A variety of traditional Chinese medicine that meets one of the following conditions may apply for secondary protection:
(a) varieties that meet the requirements of Article 6 of these regulations or varieties that have been released from first-class protection;
(two) has a significant effect on specific diseases;
(3) Effective substances and special preparations extracted from natural medicines. Article 8 New drugs approved by the drug supervision and administration department of the State Council shall be protected according to the protection period stipulated by the drug supervision and administration department of the State Council; Among them, those who meet the provisions of Article 6 and Article 7 of these regulations may apply for protection again in accordance with the provisions of these regulations six months before the expiration of the protection period approved by the drug supervision and administration department of the State Council. Article 9 Procedures for applying for protection of varieties of traditional Chinese medicines:
(a) Chinese medicine production enterprises can apply to the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government for the production of Chinese medicine varieties that meet the provisions of Articles 5, 6, 7 and 8 of these Regulations, and the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government will sign opinions in the first instance and report them to the pharmaceutical supervisory and administrative departments of the State Council. Under special circumstances, Chinese medicine production enterprises can also directly apply to the drug supervision and administration department of the State Council.
(2) The drug supervision and administration department of the State Council entrusted the National Traditional Chinese Medicine Variety Protection Review Committee to review the varieties of traditional Chinese medicine that applied for protection. The National Evaluation Committee for Variety Protection of Traditional Chinese Medicine shall make an evaluation conclusion within six months from the date of receiving the application report.
(3) The drug supervision and administration department of the State Council shall decide whether to grant protection according to the evaluation conclusion of the National Evaluation Committee for the Protection of Traditional Chinese Medicine Varieties. The varieties of traditional Chinese medicine approved for protection shall be issued with certificates of varieties of traditional Chinese medicine protection by the drug supervision and administration department of the State Council.
The drug supervision and administration department of the State Council is responsible for organizing the National Evaluation Committee for the Protection of Traditional Chinese Medicine Varieties. The members of the Committee are experts in medical treatment, scientific research, inspection, operation and management of traditional Chinese medicine hired by the drug supervision and administration department of the State Council. Article 10 An enterprise applying for the protection of varieties of traditional Chinese medicines shall submit complete information to the National Evaluation Committee for the Protection of Varieties of Traditional Chinese Medicines in accordance with the provisions of the drug supervision and administration department of the State Council. Eleventh varieties of traditional Chinese medicine approved for protection and varieties of traditional Chinese medicine whose protection expires shall be announced by the drug supervision and administration department of the State Council in the designated professional newspapers and periodicals. Chapter III Protection of Protected Varieties of Traditional Chinese Medicine Article 12 Duration of Protection of Protected Varieties of Traditional Chinese Medicine:
The first-class protected varieties of traditional Chinese medicine are 30 years, 20 years and 10 years respectively.
The second-class protected varieties of traditional Chinese medicine are seven years. Article 13 During the protection period, the production enterprises, relevant pharmaceutical supervisory and administrative departments, and relevant units and individuals who have obtained the certificate of protected varieties of traditional Chinese medicines shall be responsible for keeping the prescription composition and technical preparations of the first-class protected varieties of traditional Chinese medicines confidential and shall not disclose them.
The relevant departments, enterprises and units responsible for confidentiality shall, in accordance with the relevant provisions of the state, establish the necessary confidentiality system. Article 14 The prescription composition and technological method of transferring the first-class protected varieties of traditional Chinese medicine to foreign countries shall be handled in accordance with the relevant state provisions on confidentiality. Article 15 Where it is necessary to extend the protection period of the first-class protected varieties of traditional Chinese medicine due to special circumstances, the production enterprise shall report in accordance with the procedures stipulated in Article 9 of these regulations six months before the expiration of the protection period of the varieties. The extended protection period is determined by the drug supervision and administration department of the State Council according to the evaluation results of the National Traditional Chinese Medicine Variety Protection Evaluation Committee; However, each extension of the protection period shall not exceed the first approved protection period. Article 16 After the expiration of the protection period of the second-class protected varieties of traditional Chinese medicine, it can be extended for seven years.
The application for extending the protection period of the second-class protected varieties of traditional Chinese medicine shall be declared by the production enterprise in accordance with the procedures stipulated in Article 9 of these regulations six months before the expiration of the protection period. Seventeenth varieties of traditional Chinese medicine approved for protection are limited to the production of enterprises that have obtained the certificate of traditional Chinese medicine protection varieties during the protection period; However, unless otherwise provided for in Article 19 of these Regulations. Article 18 Where the varieties of traditional Chinese medicine approved for protection by the drug supervision and administration department of the State Council were produced by many enterprises before approval, the enterprises that did not apply for the certificate of protection of traditional Chinese medicine varieties shall report to the drug supervision and administration department of the State Council within six months from the date of announcement, and provide relevant information in accordance with the provisions of Article 10 of these regulations. The drug supervision and administration department of the State Council designated a drug inspection agency to conduct quality inspection on the declared varieties. According to the test results, the drug supervision and administration department of the State Council can take the following measures:
(a) to meet the national drug standards, the replacement of traditional Chinese medicine protection certificate.
(2) For those who do not meet the national drug standards, the approval number of the traditional Chinese medicine variety shall be revoked in accordance with the provisions of drug administration laws and administrative regulations.