General Provisions
Article 1
In order to improve the quality of traditional Chinese medicine varieties, protect the legitimate rights and interests of traditional Chinese medicine production enterprises, and promote the development of traditional Chinese medicine, these regulations are formulated.
Article 2
These regulations apply to varieties of traditional Chinese medicine produced and manufactured in China, including proprietary Chinese medicines, extracts of natural medicines and their preparations, and artificial products of traditional Chinese medicines.
Applying for patents on traditional Chinese medicine varieties 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 traditional Chinese medicine varieties, and implements a graded protection system for traditional Chinese medicine varieties with stable quality and proven efficacy.
Article 4
The health administration department of the State Council is responsible for the supervision and management of the protection of traditional Chinese medicine varieties nationwide. The national competent department for the production and operation of traditional Chinese medicines coordinates the management of the protection of traditional Chinese medicine varieties across the country. Classification and approval of protected varieties of traditional Chinese medicine
Article 5
The varieties of traditional Chinese medicine protected in accordance with these regulations must be varieties included in the national drug standards. Varieties that have been identified by the health administration department of the State Council and listed as drug standards for provinces, autonomous regions, and municipalities directly under the Central Government can also apply for protection.
Protected traditional Chinese medicine varieties are divided into first and second levels.
Article 6
Traditional Chinese medicine varieties that meet one of the following conditions can apply for first-level protection:
(1) Those with special curative effects on specific diseases;
(2) Artificial products equivalent to national first-level protected wild medicinal species;
(3) Used to prevent and treat special diseases.
Article 7
Traditional Chinese medicine varieties that meet one of the following conditions may apply for secondary protection:
(1) Those that meet the provisions of Article 6 of these Regulations Varieties or varieties that have been lifted from first-level protection;
(2) Those with significant curative effects on specific diseases;
(3) Effective substances and special preparations extracted from natural medicines.
Article 8
New drugs approved by the health administrative department of the State Council shall be protected according to the protection period prescribed by the health administrative department of the State Council; among them, those that comply with the provisions of Articles 6 and 7 of these Regulations , you may reapply for protection in accordance with the provisions of these Regulations six months before the expiration of the protection period approved by the health administrative department of the State Council.
Article 9
Procedures for application for protection of varieties of traditional Chinese medicines:
(1) Traditional Chinese medicine production enterprises shall comply with Article 5 and Article 5 of these Regulations For varieties of traditional Chinese medicines specified in Articles 6, 7, and 8, applications may be submitted to the competent departments for the production and distribution of traditional Chinese medicines in the provinces, autonomous regions, and municipalities directly under the Central Government where they are located. After the competent departments for the production and distribution of traditional Chinese medicines sign their opinions, they will be forwarded to the health administrative department at the same level. After the health administrative departments of autonomous regions and municipalities directly under the Central Government sign their opinions after the preliminary review, they will be reported to the health administrative department of the State Council. Under special circumstances, traditional Chinese medicine manufacturing enterprises may also apply directly to the national Chinese medicine production and distribution department, which will sign an opinion and forward it to the health administration department of the State Council, or directly apply to the health administration department of the State Council.
(2) The health administration department of the State Council entrusts the National Traditional Chinese Medicine Variety Protection Review Committee to review the traditional Chinese medicine varieties applied for protection. The National Traditional Chinese Medicine Variety Protection Review Committee shall make a review conclusion within six months from the date of receipt of the application report.
(3) Based on the review conclusion of the National Traditional Chinese Medicine Variety Protection Review Committee, the health administration department of the State Council shall decide whether to grant protection after soliciting the opinions of the national Chinese medicine production and distribution authorities. For varieties of traditional Chinese medicine approved for protection, the health administration department of the State Council will issue a "Certificate of Protected Types of Traditional Chinese Medicine".
The health administration department of the State Council is responsible for organizing the National Traditional Chinese Medicine Variety Protection Review Committee. The members of the committee are appointed by the health administration department of the State Council after consultation with the national Chinese medicine production and operation department. They are responsible for the medical treatment, scientific research, inspection and operation of traditional Chinese medicine. , management experts serve.
Article 10
Enterprises applying for protection of traditional Chinese medicine varieties shall submit complete information to the National Traditional Chinese Medicine Variety Protection Review Committee in accordance with the regulations of the health administration department of the State Council.
Article 11
Chinese medicine varieties approved for protection and Chinese medicine varieties whose protection period has expired shall be announced by the health administration department of the State Council in designated professional newspapers and periodicals. Protection of protected varieties of traditional Chinese medicine
Article 12
The protection period of protected varieties of traditional Chinese medicine:
The first-level protected varieties of traditional Chinese medicine are thirty years and twenty years respectively. Years, ten years.
Class II protected varieties of traditional Chinese medicine last for seven years.
Article 13
The prescription composition and manufacturing process of first-level protected varieties of traditional Chinese medicines shall be controlled by the production enterprises and relevant drugs that have obtained the "Certificate of Protected Types of Traditional Chinese Medicines" within the protection period. The production and operation departments, health administrative departments and relevant units and individuals are responsible for keeping the information confidential and shall not make it public.
Relevant departments, enterprises and units with confidentiality responsibilities should establish necessary confidentiality systems in accordance with relevant national regulations.
Article 14
The transfer of prescription compositions and manufacturing methods of first-level protected varieties of traditional Chinese medicine to foreign countries shall be handled in accordance with the relevant national confidentiality regulations.
Article 15
If the protection period of a first-level protected variety of traditional Chinese medicine needs to be extended due to special circumstances, the production enterprise shall, six months before the expiration of the protection period of the variety, in accordance with Article 1 of these Regulations Declaration of procedures stipulated in Article 9. The extended protection period shall be determined by the health administrative department of the State Council based on the review results of the National Traditional Chinese Medicine Variety Protection Review Committee; however, each extended protection period shall not exceed the first approved protection period.
Article 16
Class II protected varieties of traditional Chinese medicine can be extended for seven years after the expiration of the protection period.
For second-level protected varieties of traditional Chinese medicine that apply for extension of the protection period, the production enterprise shall apply in accordance with the procedures stipulated in Article 9 of these Regulations six months before the expiration of the protection period.
Article 17
The varieties of traditional Chinese medicines approved for protection shall be produced by enterprises that have obtained the "Certificate of Protected Types of Traditional Chinese Medicines" during the protection period; however, Article 19 of these Regulations Unless otherwise specified.
Article 18
If the varieties of traditional Chinese medicines approved for protection by the health administration department of the State Council were produced by multiple enterprises before approval, those enterprises that have not applied for the "Certificate of Protected Varieties of Traditional Chinese Medicines" Applications shall be made to the health administration department of the State Council within six months from the date of the announcement, and relevant information shall be provided in accordance with the provisions of Article 10 of these Regulations. The drug inspection agency designated by the health administration department of the State Council shall conduct quality inspection of the same variety for the declared variety. Based on the inspection results, the health administrative department of the State Council may take the following measures:
(1) For those that meet the national drug standards, the "Certificate of Protected Varieties of Traditional Chinese Medicine" will be reissued after seeking the opinions of the national department in charge of production and operation of traditional Chinese medicines.
(2) For those that 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 laws and administrative regulations on drug management.
Article 19
For protected varieties of traditional Chinese medicines that are in short supply for clinical use, based on the imitation recommendations put forward by the national competent department for the production and operation of traditional Chinese medicines and approved by the health administration department of the State Council, the imitation enterprise shall The health administrative departments of the provinces, autonomous regions and municipalities directly under the Central Government shall issue approval numbers to enterprises producing the same protected variety of traditional Chinese medicine. The enterprise shall pay a reasonable usage fee to the enterprise that holds the "Certificate of Protected Varieties of Traditional Chinese Medicine" and transfers the prescription composition and manufacturing process of the traditional Chinese medicine variety. The amount shall be agreed upon by both parties; if the two parties cannot reach an agreement, the decision shall be made by the health administration department of the State Council. .
Article 20
Enterprises that produce protected varieties of traditional Chinese medicines and the competent departments for the production and operation of traditional Chinese medicines shall improve production conditions and enhance Variety quality.
Article 21
If a protected variety of traditional Chinese medicine applies for registration abroad during the protection period, it must be approved by the health administrative department of the State Council.
Penalties
Article 22
Any person responsible for violating the provisions of Article 13 of these Regulations and causing leakage of secrets shall be given administrative sanctions by his/her unit or superior authority; this constitutes a crime , be held criminally responsible in accordance with the law.
Article 23
Anyone who violates the provisions of Article 17 of these Regulations and imitates protected varieties of traditional Chinese medicine without authorization shall be punished according to law by the health administrative department at or above the county level for producing counterfeit medicines.
Anyone who forges the "Certificate for the Protection of Traditional Chinese Medicine Variety" and relevant certification documents for production and sales shall have all relevant drugs and illegal income confiscated by the health administrative department at or above the county level, and may impose a fine of less than three times the genuine price of the relevant drugs. fine.
If the above-mentioned behavior constitutes a crime, criminal responsibility shall be investigated by the judicial authorities in accordance with the law.
Article 24
If the party concerned is dissatisfied with the penalty decision of the health administrative department, he may apply for administrative reconsideration or file an administrative lawsuit in accordance with the provisions of relevant laws and administrative regulations. Supplementary Provisions
Article 25
The application requirements and application forms for protected varieties of traditional Chinese medicine shall be formulated by the health administration department of the State Council.
Article 26
The health administrative department of the State Council is responsible for the interpretation of these Regulations.
Article 27
This Regulation shall come into effect on January 1, 1993.