Scope of application of the regulations on the protection of varieties of traditional Chinese medicine

Applicable: varieties of traditional Chinese medicine produced and manufactured in China. Including: proprietary Chinese medicines, extracts of natural medicines and their preparations and manufactured products of Chinese medicine. 2, does not apply: apply for patent varieties of traditional Chinese medicine, in accordance with the provisions of the Patent Law.

Purpose and significance of the protection of varieties of traditional Chinese medicine:

1, the state encourages the development of clinically effective varieties of traditional Chinese medicine, stable quality and efficacy of varieties of traditional Chinese medicine to implement a graded protection system.

2. Purpose: In order to improve the quality of varieties of traditional Chinese medicine, to protect the legitimate rights and interests of manufacturers of traditional Chinese medicine, and to promote the development of traditional Chinese medicine.

Applicable to varieties of Chinese medicines produced and manufactured within the territory of China, including proprietary Chinese medicines, extracts of natural medicines and their preparations, and artificial products of Chinese medicines. Patent application of Chinese medicine varieties, in accordance with the provisions of the Patent Law, does not apply to the Regulations. Except for the varieties of Chinese medicines for which patents have been applied. The State Food and Drug Administration is responsible for the supervision and management of the national protection of Chinese medicines, and the State Administration of Traditional Chinese Medicine coordinates the management of the national protection of Chinese medicine varieties. The first imported medicinal materials, refers to the imported medicinal materials that are not from the same country (region), not from the same applicant, and not from the same base material of medicinal materials. Acquisition of imported medicinal materials approval, to the port drug supervision and management department for the record; non-first import directly to the port drug supervision and management department for the record, non-first imported medicinal materials for the implementation of directory management, the specific directory by the State Drug Administration to develop and adjust.

Legal basis

"Regulations on the Protection of Varieties of Traditional Chinese Medicines" Article 2 These regulations apply to varieties of traditional Chinese medicines produced and manufactured within the territory of China, including proprietary Chinese medicines, extracts of natural medicines and their preparations, and manufactured products of traditional Chinese medicines.

The varieties of Chinese medicine for which patents have been applied for shall be handled in accordance with the provisions of the Patent Law, and these Regulations shall not apply.

Article 3 of the Regulations on the Protection of Varieties of Traditional Chinese Medicines The State encourages the development of clinically effective varieties of traditional Chinese medicines, and implements a graded protection system for varieties of traditional Chinese medicines of stable quality and precise efficacy.

Regulations on the Protection of Varieties of Traditional Chinese Medicines, Article 4 The State Council administrative department of health is responsible for the supervision and management of the protection of varieties of traditional Chinese medicines. The state department in charge of the production and management of traditional Chinese medicine coordinates the management of the protection of national varieties of traditional Chinese medicine.