Seed management approach for chinese medicine (agricultural component)
Summary of the content of the draft comments
Chapter i general provisions
Background and objectives: to protect and rationally use chinese medicine resources, regulate the selection, production, operation and management, improve quality, safeguard the legitimate rights and interests of all parties and promote industrialization。
Scope of application: china is engaged in activities related to the protection of chinese medicine and medicine resources, the selection of varieties and the operation of production。
Definition scope: the chinese pharmacological seed referred to in the scheme is a plant or breeding material for medicinal herbs and bacteria, including seed grains, fruit, roots, roots, roots, seedlings, buds, leaves, flowers, sub-entities, fungus, spores, etc。
Management and responsibilities:
Chapter ii quality resource protection
Census and evaluation: the national central medicine administration is responsible for census, collection, protection, registration, validation and evaluation, and regularly publishes a catalogue of available data。
(b) establishment of stock banks, protected areas, protected areas。
(b) prohibition of the extraction of state-protected wildlife medicines; special circumstances such as scientific research require application and processing。
Sovereignty and cooperation: states have sovereignty; foreign offers or cooperative research are subject to approval and benefit-sharing programmes。
Classification management: a classification management system is in place, with a management catalogue developed jointly by the two departments。
(b) the ministry of agriculture and rural affairs must approve the introduction of a risk assessment for the first time。
Chapter iii
Supporting directions: encourage joint breeding by research institutes, colleges and enterprises and build a technology innovation system that combines “production studies”。
Registration system: catalogue management; registration before listing; non-registered varieties may not be advertised, promoted or sold in the name of registered varieties。
Registration agency: national registration commission established by the national central medicine authority; provincial branches。
Registration process: through the platform of the national unified network, which includes applications, admissions, reviews, announcements, etc。
Five conditions for application: source compliance; artificial selection or improvement; specificity, consistency, stability; conformity of name; written consent for new plant varieties。
10 applications, including application forms, reports, photographs, pledges, other materials, etc。
Time frame for review: 20 working days for provincial first instance; no less than 15 working days after review。
Registration: the bulletin includes the registration number, the name of the chinese medicine, the name of the base (latin name), the name of the species, the applicant, the breeder, the source of the species, the characteristics, quality, yield, resistance, the technical elements of planting, the area suitable for planting and the season。
(a) historical variety treatment: the application for registration should be made within three years for varieties that have been validated prior to implementation and have not been withdrawn; the application should be submitted by the appointing authority on behalf of the designated authority。
(b) where there is a false or serious defect, the national central medicines authority removes the change; if the change is requested, the evidence is submitted and submitted through the platform。
(b) the applicant is responsible for the authenticity of the material; the registration unit and the staff member shall keep the applicant's business secret。
Chapter iv seed production operations
Licensing system: enterprises engaged in production operations are required to apply for a permit to operate crop seed production。
Licence classification:
Conditions of application: in addition to the provisions of this act, other legal and regulatory requirements shall be met。
Regulatory basis: licence processing, auditing, issuance, supervision, etc., based on reference to the crop seed production licensing scheme。
Sales regulations:
Chapter v seed standards
The national administration of chinese medicine is responsible for the development of national standards and industry standards; provincial departments are responsible for local standards; and enterprises may establish business standards that do not fall below those standards。
Testing services: encourage competent institutions to provide testing services。
Chapter vi oversight and management
Quality monitoring: the ministry of agriculture and rural development is responsible for quality monitoring and inspection; the national administration of chinese medicine has established a standard sample bank to collect, collate and store samples。
Enforcement techniques: market monitoring, case handling, judicial arbitration, etc., are procedurally called if standard samples are required。
(b) the agricultural and rural authorities above the county level combat, in accordance with the law, the production and operation of false seeds and other violations, protect the rights and interests of farmers and maintain a level playing field。
Industry self-regulation: encourage the formation of industry associations, strengthen self-regulation and provide services such as information exchange, technical training, credit building, marketing, etc。
Certification system: the operator may apply for seed quality certification on a voluntary basis and the qualified person may use the authentication sign on the packaging。
Chapter vii
Export/import conditions: in addition to a production licence, meet
Seed import and export permits are granted. The following conditions should be met:
The ministry of agriculture and rural affairs is responsible for approving and, if necessary, consulting the national administration of chinese medicine。
Legislative authority: implemented with reference to the interim scheme for the import and export of crop seeds。
Chapter viii
Legal liability: in violation of the provisions of this scheme, legal liability is imposed in accordance with the seed law of the people's republic of china, etc., and is punishable by the competent agricultural and rural sector。
Implementation date: this scheme is in effect as of 。
