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Chapter III Imported Chinese medicine materials inspection
Article 6
Imported Chinese medicine materials shall not change the form of original material or tablets ready for decoction ,and the labels or packages shall indicate name of the medicament , lot number, name and address of the pharmaceutical firms.
Reference standard and methods for the examination of imported Chinese medicine materials should abide to those mentioned in the Chinese Pharmacopoeia, pharmacopoeias published in Taiwan Herbal Pharmacopeia or otherwise publicly announced by the central health competent authority.
Article 7
For the Chinese medicine materials required for inspection by the competent authority, the obligatory inspection applicants shall submit the following documents to the inspection authority to carry out the inspection:
1. An application form for inspection.
2. A copy of Chinese medicines pharmaceutical firms permit license.
3. A copy of application for import declaration.
4. A certificate of examination issued by the laboratories approved by central health competent authority, Chinese medicine manufacturers in compliance with Pharmaceutical Good Manufacturing Practice Regulations, or related competent authority from the country of origin.
5. Necessary documents required by the competent authority.
The application of the preceding paragraph can be submitted electronically.
Chinese medicine materials that conform to one of the following situations can be exempted from inspection:
1. Products to be imported are issued with a certificate of examination by the government of the country of origin who has signed an inspection waiver reciprocity agreement with the government of the Republic of China.
2. The samples are permitted to import by the central competent health authority for the certificate of inspection pursuant to the fourth sub-paragraph of the first paragraph.
3. A special permit from central competent health authority granted for national emergency situation or to improve the public welfare.
Article 8
In addition to documentation review (as prescribed in Article7), inspection authority can carry out the Chinese medicine materials inspection in one or some of the following measures:
1. Batch-by-batch examination: The inspection is carried out for each submitted batch of Chinese medicine materials.
2. Randomly-selected batch examination: The inspection is performed based on a 2%-50% inspection rate.
3. On-site inspection: verification of items, packaging, appearance and labels of products on site.
Article 9
If any violation of Article 6 is found during the on-site inspection for the Chinese medicine materials , a notice shall be given by inspection authorities and the obligatory inspection applicants shall make correction within a prescribed time period; and submit to recheck afterwards.