For drugs 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 medicaments permit license or import certificate issued by the central competent health authority.
3. A copy of application for import declaration.
4. Necessary documents required by the central competent authority.
The application of the preceding paragraph can be submitted electronically.
Drugs pursuant to the first Paragragh 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 examination waiver reciprocity agreement with the government of the Republic of China.
2. A special permit from central competent health authority granted for national emergency situation or to improve the public welfare.

In addition to documentation review (as prescribed in Article 3), inspection authority can carry out the inspection of drugs in one or some of the following measures:
1. Batch-by-batch examination: carried out for each submitted batch of drugs.
2. Randomly-selected batch examination: performed based on a 2%-50% inspection rate.
3. On-site inspection: inspecting and checking (hereinafter referred to as ‘verification’) of items, packaging, appearance and labels of products on site.

For active pharmaceutical ingredients (as raw materials in Article 16 of Pharmaceutical Affairs Act) that belong to classification codes in Chapters 28 and 29 of the Import and Export Commodity Classification of the Republic of China, management of randomly-selected batch examination in Subparagraph 2 of the foregoing article are as follows:
1. For those randomly-selected:
(1) Testing is done through rapid test instruments. Once determined as illicit drugs, they are to be forwarded to the customs or judicial/police authority for investigation.
(2) When test results cannot be determined or it is impossible to perform testing with rapid testing instruments, they shall be sealed immediately and may not be unpacked without authorization.
(3) For drugs that are sealed according to preceding item, the inspection authority may issue the notice allowing prior release of imported drugs to facilitate customs declaration after the applicant has prepared the affidavit as required by Article 18 and enclosed supporting documents for compliance of the storage site with the Regulations for Good Manufacturing Practice or having filed for reference with the competent municipal and county (city) health authority. The storage site, without prior approval from the inspection authority, may not be changed unilaterally.
(4) The applicant indicated in the preceding item shall proactively notify the inspection authority for sending staff to the location compliance with the Pharmaceutical Good Manufacturing Practice Regulations for unsealing and examination. Those having met requirements shall be managed according to Article 19.
(5) The quantities involved in the randomly-selected batch examination are indicated in Annex 1.
2. For batches not being selected, the inspection authority will review the application documents. Those having met requirements shall be managed according to Article 19.

• Annex I.pdf
• Annex I.doc

Reference standard and methods for the examination of imported drugs should abide to those mentioned in the Chinese Pharmacopoeia, pharmacopoeias published in the A10 countries or otherwise publicly announced by the central health competent authority.