8-2-1 Drugs1
In accordance with the Measures for Drug Administration, drug production enterprises must obtain a drug production licence while drug distribution enterprises are required to acquire a drug business licence. Enterprises planning to engage in drug production should apply to the local drug administration department at provincial, autonomous region or municipal levels for a drug production licence. Similarly, enterprises planning to set up drug wholesale business should apply to the local drug administration department at provincial, autonomous region or municipal levels for a drug business licence. As regards drug retail enterprises, application for a drug business licence can be lodged with the local drug administration department at county level or above. With the licence, the enterprise can then apply for business registration with the industry and commerce administration. Both the drug production licence and the drug business licence carry information on their validity period and the enterprise's permitted business scope. Upon expiry of the licence, the enterprise will undergo examination again for the renewal of the licence.
Supervisory Authority
The food and drug administration at various levels
8-2-2 Liquor
Licences are required for the production, wholesale and retail of liquor in the mainland. Under the Regulations on the Administration of Liquor Monopoly, liquor production enterprises must obtain a health licence from the health department and a liquor production licence from the provincial liquor monopoly administration department. Upon acquiring these two licences, the liquor production enterprise can then apply for a business licence from the industry and commerce administration. For enterprises engaging in the wholesale and retail of liquor, a health licence should be obtained from the health department and a licence for the wholesale and retail of liquor monopoly from the local liquor sale monopoly administration department at prefectural level or above. Application can then be lodged with the industry and commerce administration for a business licence.
In sourcing liquor, liquor wholesalers must demand for an inspection certificate and a certificate of origin for the goods. If the product packaging carries a quality mark, the relevant certification document should also be sought.
Imported liquor is inspected by the food hygiene supervisory authorities at the port of entry and will only be allowed entry upon passing the inspection.
Supervisory Authority
Liquor monopoly administration departments at various levels
8-2-3 Medical Equipment
Under the Regulations for the Administration and Supervision of Medical Equipment, enterprises engaging in the distribution of Category 2 and Category 3 medical equipment must hold a medical equipment business licence2. The licensing requirement is waived for a small number of Category 2 medical equipment which is found to be safe and effective in the course of regular monitoring. A list of Category 2 medical equipment not requiring a business licence is compiled by the State Food and Drug Administration.
A medical equipment business licence is valid for five years. Application for renewal should be made six months prior to the expiry date to the food and drug administration departments at provincial, autonomous region or municipal levels or the food and drug administration departments at city level delegated with such responsibilities.
Supervisory Authority
The State Food and Drug Administration is responsible for supervising and managing medical equipment business licences across the country. The issue, renewal, amendment and daily supervision of the licences are handled by the food and drug administration departments at provincial, autonomous region and municipal levels or their subsidiary food and drug administration offices at county level.
8-2-4 Distribution of Books, Newspapers and Periodicals
Foreign-invested enterprises distributing books, newspapers and periodicals in the mainland should abide by the Measures for the Administration of Foreign-Invested Distribution Enterprises for Books, Newspapers and Periodicals. They must obtain a publications business licence and a foreign-invested enterprise approval certificate before they can apply for a business licence from the industry and commerce administration.
Supervisory Authority
The state press and publications administration departments and the commerce departments
8-2-5 Audio-Visual Products
Under the Regulations for the Administration of Audio-Visual Products, enterprises engaging in the distribution of such products should obtain an audio-visual products business licence.
Supervisory Authority
The establishment of audio-visual products wholesale enterprises is approved by the provincial culture departments, while the establishment of retail and leasing businesses is approved by the culture department at county level.
8-2-6 Refined Oil Products
In accordance with the Provisional Measures for the Administration of the Refined Oil Products Market, businesses engaging in the wholesale and retail of refined oil products should obtain a refined oil products wholesale approval certificate and a refined oil products warehousing approval certificate.
Supervisory Authority
The refined oil products wholesale approval certificate is issued by the Ministry of Commerce, while the retail and warehousing approval certificates are issued by the commerce department at provincial level.
8-2-7 Edible Salt
Under the Measures for the Sale of Edible Salt and the Regulations for the Administration of the Salt Industry, edible salt manufacturers should obtain a designated enterprise approval document and a health licence, while edible salt wholesalers should acquire an edible salt wholesale licence.
Supervisory Authority
The state salt administration department is responsible for issuing designated enterprise approval documents. For iodine-salt processing, an approval document issued by the state salt administration department and a health licence from the health administration department are required. Edible salt wholesale licences are issued by the provincial salt administration department and the retail of edible salt is approved by the commodities distribution administration departments.
8-2-8 Dangerous Chemicals
Under the Safe Production Law and the Regulations for the Administration of Safety of Dangerous Chemicals, enterprises dealing in dangerous chemicals should obtain a dangerous chemicals business licence from the supervisory authorities on safe production at city level or above.
| 1. |
The distribution of Chinese herbal medicines requires a drug (Chinese herbal medicine) business certificate issued by the traditional Chinese medicine administration department at provincial level and a drug business licence issued by the drug administration department (formerly the health department). |
| 2. |
Condoms are classified as Category 2 medical equipment by the State Food and Drug Administration requiring a medical equipment production licence and medical equipment registration certificate. At the same time, they are considered disposable health products by the Health Department requiring a health licence, and are subject to mandatory quality certification by the State Administration of Quality Supervision, Inspection and Quarantine. |
