Without a "Drug-production Enterprise Licence", the department administering industry and commerce may not issue a "Business Licence".
The "Drug-production Enterprise Licence" shall stipulate its period of validity, and at the expiry of the period the issue of the licence shall be examined afresh. Specific procedures will be determined by the State Council department responsible for health administration.
[Article 5] The establishment of an enterprise to produce drugs must satisfy the following conditions:
(1) It must employ pharmacists, technical personnel above the rank of assistant engineer and technical workers appropriate to the drug production carried out by the enterprise.
Where an enterprise engaged in the processing of traditional Chinese medicine does not have a pharmacist or technical personnel of a rank above that of assistant engineer, it may use drug industry personnel with an intimate knowledge of drugs who have been examined and registered by a department of health administration above the county level.
(2) It must have a factory building, facilities and a hygienic environment appropriate to its production of drugs.