with the package insert, relevant information such as quality standard and control procedure, a sample of suitable size. and a certification of the exporting country (or locality).
Article 28 Drugs to be imported should be examined by drug control institutions duly authorized by the Ministry of Public Health. The importation of a drug will not be approved unless it is found to be up to standard.
The importation of a small number of drugs to meet the urgent clinical needs of a medical unit or for personal self- medication should follow the formalities of the Customs.
Article 29 The Ministry of Public Health has the autho- rity to restrict or prohibit the exportation of herbal drugs and their preparations if they are in short supply in the domestic market.
Article 30 The importation or exportation of narcotic drugs and psychotropic substances falling into the scope de- termined by the Ministry of Public Health is not allowed unless the importer or exporter is the holder of an "import license" or "export license" issued by the Ministry of Public Health.
Article 31 The sale of herbal drugs newly discovered or introduced from abroad is not allowed unless it is approved by the health bureau of province, autonomous region or municipality.
Article 32 Detailed provisions for the control of folk
-36--
medicines in certain regions will be stipulated by the Ministry of Public Health.
Article 33 The production and sale of bogus drugs are prohibited. A drug is deemed to be bogus if one of the following criteria exists:
1) The name of its ingredients shown on the label is different from the official designation used in the national, provincial, autonomous regional or municipal drug standard for the same substance.
2) It is not the same drug which is claimed by its name, or in reality it is not a drug at all.
Drugs falling into one of the following categories will also
be subject to the same handling as bogus drugs:
1) The use has been prohibited by the Ministry of Public Health.
2) The production has not been approved.
3) Deteriorated,
4) Contaminated.
Article 34 The production and sale of drugs of inferior quality is prohibited. A drug is deemed to be of inferior quality if one of the following criteria exists:
1) The content of its ingredients does not comply with that which is specified in the national, provincial, autone mous regional or municipal drug standard.
2 The date of expiration is exceeded.
-37-
Page 135Page 136