Article
Drugs should not be dispatched from the fa ctory before their quality examination has been completed or if they are found to be substandard.
Article 9 Drug manufacturing enterprises must stipulate and implement the rules, regulations and hygienic require- ments in accordance with the instructions set forth in the “No- rms of Quality Control in Drug Production by the Ministry of Public Health so as to guarantee the quality of drugs.
CHAPTER I
THE CONTROL OF DRUG
HANDLING ENTERPRISES
Article 10 The establishment of a drug handling enter- prise must be approved by the competent authorities in charge. of the production and management of drugs of the relevant
province, autonomous region or municipality, and sanctioned by the health bureau above the county level. A“drug handler certificate" will then be issued. Without this certificate,
no business license" will be granted by the industrial and commercial management agency.
A date of expiration should be fixed for each "drug handler certificate", and an application for the renewal of a certificate should be submitted before it expires. Relevant regulations of the certification procedure will be stipulated by the Ministry of Public Health.
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Article 11 A drug handling enterprise should be estab- lished on the following basis:
1) It should be staffed with an adequate number of phar- maceutical technicians adaptable to the scale of its business. Enterprises engaged in the handling of herbal drugs or partly engaged in the handling of drugs may be staffed with pharmaceutical professionals familiar with the property drugs and registered with the health bureau above the county level if pharmaceutical technicians are not available.
2) It should have adequate premises, and equipment and storing facilities adaptable to the scale of its business, well as a hygienic environment.
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Article 12 The quality of drugs should be examined on purchasing; substandard products should not be bought.
Article 13 Care should be taken to avoid mistakes in the sale of drugs. The usage, dosage and precautions should be properly stated. Drugs dispensed for any prescription should be checked for any discrepancies, and no ingredient of any prescription should be altered or substituted. Incompa- tible or over-dosaged prescriptions should be refused, unless amendments have been made by the prescriber or re-signed by him.
Genuine herbal drugs on sale should be labelled with their origin.
Article 14 Drug warehouses must stipulate and imple-
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