Chapter 1 General Principles

Article 1 In order to improve the quality of Chinese medicine varieties，Protect the legitimate rights and interests of traditional Chinese medicine production enterprises，Promoting the development of traditional Chinese medicine，Develop this Regulations。

Article 2 These regulations are suitable for Chinese medicine varieties in production and manufacturing in China，Including Chinese medicine、Extraction of natural drugs and products and Chinese medicine artificial products。

Chinese medicine varieties applying for patents，Application in accordance with the provisions of the Patent Law，Not applicable this Regulations。

Article 3 The state encourages the development and development of Chinese medicine varieties with effective clinical and effective Chinese medicine，Stability of quality、Chinese medicine varieties with accurate effects implement a classification protection system。

Article 4 The health administrative department of the State Council is responsible for the supervision and management of the protection and management of the nation's Chinese medicine species。National Chinese Medicine Production and Management Department Cooperation Manage the Protection of National Chinese Medicine Variety。

Chapter 2 Division and Approval of Chinese Medicine Protection Variety Levels

Article 5 of the Chinese medicine variety protected in accordance with these regulations，It must be a variety of national drug standards。Decided by the health administrative department of the State Council，Line as province、Autonomous Region、Variety of drug standards in municipalities directly under the Central Government，You can also apply for protection。
The protected Chinese medicine varieties are divided into first and second.

Article 6 of the Chinese medicine variety that meets one of the following conditions，You can apply for first -level protection:
(1) It has special effects on specific diseases;
(2) It is equivalent to artificial products that are equivalent to national Stake Sports Bettingfirst -level protective wild medicinal species;
(3) It is used to prevent and treat special diseases.

Article 7 of Chinese medicine varieties that meet one of the following conditions，You can apply for secondary protection:
(1) Compliance with the varieties stipulated in Article 6 of these regulations or the varieties that have been lifted first protection;
(2) It has a significant effect on specific diseases;
(3) Effective substances and special preparations extracted from natural drugs。

Article 8 New medicine approved by the health administrative department of the State Council，Protecting the protection period prescribed by the health administrative department of the State Council;，Compliance with Article 6 of these Regulations、Seventh specified，Six months before the protection period approved by the health administrative department of the State Council，You can re -apply for protection in accordance with the provisions of these regulations。

9 Application procedures for the protection of Chinese medicine varieties:
(1) Chinese medicine manufacturers are complying with Article 5 of these regulations、Article 6、Article 7、Chinese medicine varieties specified in Article 8，It can be provided in the local area、Autonomous Region、The competent department of traditional Chinese medicine production and operation of municipalities directly under the Central Government will apply，Signed the competent department of traditional Chinese medicine after signing opinions, transferred to the health administrative department of the same level，From the province、Autonomous Region、After the preliminary review of the health administrative department of the municipality directly under the Central Government，Report the health administrative department of the State Council。In special circumstances，Chinese medicine production enterprises can also apply directly to the competent department of traditional Chinese medicine production and operation，Signed an opinion by the competent department of traditional Chinese medicine production and operation, transferred to the health administrative department of the State Council，or apply directly to the health administrative department of the State Council。
(2) The State Council ’s health administrative department entrusts the National Traditional Chinese Medicine Product Protection Review Committee to be responsible for reviewing the Chinese medicine varieties for protection。The National Medicine Protection Review Committee shall make a review conclusion within six months from the date of receiving the application report。
(3) According to the review conclusion of the National Medicine Protection Review Committee，After the State Council ’s health administrative department sought the opinions of the competent department of traditional Chinese medicine production and operation, decided to be protected。Chinese medicine varieties approved for protection，issued by the State Council's Health Administrative Department to "Certificate of Protection of Chinese Medicine Protection"。
The Health Administrative Department of the State Council is responsible for organizing the National Chinese Medicine Protection Review Committee，Members of the committee shall be negotiated by the health administrative department of the State Council and the competent department of traditional Chinese medicine production and operation，Hire medical treatment in Chinese medicine、Scientific Research、Inspection Stake Sports Bettingand operation、Management experts as。

Article 10 Enterprises applying for the protection of traditional Chinese medicine，shall be in accordance with the provisions of the health administrative department of the State Council，Submit a complete information to the National Traditional Chinese Medicine Protection Review Committee。

1 11，The health administrative department of the State Council will be announced in the designated professional newspapers

Chapter 3 Protection of Traditional Chinese Medicine Protection Article 12 The protection period of the protection of traditional Chinese medicine:
Chinese medicine first -level protection varieties are thirty years, respectively、Twenty years、Ten Years。
Traditional Chinese medicine secondary protection varieties are seven years.

Article 13 The prescription composition of the first -level protection variety of traditional Chinese medicine、Craft Method，Production enterprises that obtain the "Chinese Medicine Protection Variety Certificate" within the protection period and related drug production and operation authorities、The health administrative department and relevant units and individuals are responsible for confidentiality，No disclosure。
Relevant departments with confidentiality liability、Enterprises and units shall be in accordance with relevant national regulations，Create the necessary confidentiality system。

Article 14 The prescription composition of the first -level protection variety of traditional Chinese medicine to foreign countries、Craft Method，It shall be handled in accordance with the regulations of the confidentiality of the country。

Article 15 The first -level protection variety of traditional Chinese medicine needs to extend the protection period due to special circumstances，The production enterprise six months before the protection period of this variety，Application in accordance with the procedure stipulated in Article 9 of these Regulations。The extended protection period is determined by the health administrative department of the State Council according to the review results of the National Medicine Protection Review Committee; but，The protected period of each extension must not exceed the first approved protection period。

Article 16 The second -level protection variety of traditional Chinese medicine can be extended for seven years after the protection period expires。
Application for extending the protection period of Chinese medicine second -level protection varieties，It should be six months before the protection period，Application of procedures stipulated by the production enterprise in accordance with Article 9 of these Regulations。

Article 17 of Chinese medicine varieties that have been approved and protected，During the protection period, it is limited to enterprises produced by the "Certificate of Protection of Chinese Medicine" during the protection period; but，Article 19 of these Regulations, except as specified。

Article 18 The Chinese medicine varieties approved by the health administrative department of the State Council if they are produced Stake Sports Bettingby a number of enterprises before approval，Among them, companies that have not applied for the "Chinese Medicine Protection Variety Certificate" shall declare to the health administrative department of the State Council within six months from the announcement of the announcement，and provide relevant information in accordance with the provisions of Article 10 of these regulations，Drug inspection agencies designated by the health administrative department of the State Council to test the quality inspection of the same variety for the specifications。The health administrative department of the State Council is based on the test results，The following measures can be taken:
(1) For the standard of national drug standards，After the opinion of the competent department of traditional Chinese medicine production and operation，Refined "Chinese Medicine Protection Variety Certificate"。
(2) For those who have not met the national drug standard，​​According to the law of drug management、The regulations of administrative regulations revoke the approval number of the Chinese medicine variety。

Article 19 of Chinese medicine protection varieties that are short of clinical medication，According to the imitation suggestion proposed by the competent department of traditional Chinese medicine production and operation，Approved by the health administrative department of the State Council，The province where the imitation enterprise is located、Autonomous Region、The health administrative department of the municipality directly under the Central Government issues an approval number of enterprises that produce the same Chinese medicine protection varieties。The company should pay the prescription composition of holding the "Chinese Medicine Protection Variety Certificate" and transferring the variety of Chinese medicine、Reasonable use fees for enterprises in the process system，The amount is agreed by both parties; the two parties cannot reach the agreement，Rules of the Health Administrative Department of the State Council。

Article 20，It should be according to the province、Autonomous Region、Requirements made by the health administrative department of the municipality directly under the Central Government，Improve production conditions，Improve the quality of the variety。

Article 21: Chinese medicine protection varieties apply to register from foreign abroad during the protection period，Must be approved by the health administrative department of the State Council。

Chapter 4 Punishment Rules

Article 22 Violation of Article 13 of these Regulations，Responsible persons who cause leaks，Given administrative sanctions by its unit or higher organs;，Criminal responsibility for investigation in accordance with the law。

Article 23: The provisions of Article 17 of these Regulations，，The health administrative department at or above the county level is based on the production of fake medicines。

Forged "Protection Certificate of Chinese Medicine Variety" and related certification documents for production、Sales，from the health administrative department at or above the county level to confiscate all the relevant drugs and illegal income，and can be punished with a fine of less than three times the price of the relevant drugs。

The above behavior constitutes a crime，Criminal liability for judicial organs。

Article 24: The parties are not convinced by the party's punishment decision on the health Stake Sports Bettingadministrative department，You can follow relevant laws、Regulations on administrative regulations，Apply for administrative reconsideration or file an administrative lawsuit。

Chapter 5 Attachment

Article 25: Declaration requirements for the species of traditional Chinese medicine protection、declaration form, etc.，Formulated by the health administrative department of the State Council。

Article 26 These regulations shall be explained by the health administrative department of the State Council。

Article 27 This Regulations shall be implemented from January 1, 1993。