Quarantine Requirements for the Importation of Fetal Bovine Serum
from Paraguay (Draft)
(In case of any discrepancy between the English version and the Chinese text of these Requirements, the Chinese text
shall govern.)
1. The “Quarantine Requirements for the Importation of Fetal Bovine 
Serum from Paraguay” (hereinafter these Requirements) regulate the 
importation of serum derived from fetus of animals of the Subfamily 
Bovinae.
2. Testing referred to in these Requirements must be conducted by labora -
tories owned, designated or approved by the government of the export -
ing country using methods listed in these Requirements; or prescribed, 
recommended or considered suitable by the World Organisation for An -
imal Health (OIE) Manual of Diagnostic Tests and Vaccines for Terres -
trial Animals (hereinafter the OIE Manual) for confirmation of popula -
tion or individual animals being free from infection with pathogens of 
corresponding diseases. For diseases with no such testing methods pre -
scribed, recommended or considered suitable in the OIE Manual, meth -
ods that have been published in international scientific journals may 
also be used.
3. Paraguay must have no confirmed case of foot and mouth disease and 
contagious bovine pleuropneumonia occurring during the 5 years prior 
to the manufacturing of fetal bovine serum (hereinafter FBS) for export.
4. For FBS from the Paraguay, only that which is manufactured by desig -
nated serum processing facilities is eligible to be imported. In addition, 
only government institutions (agencies), publically operated companies,
private companies, academic institutions, and legal persons, are allowed
to import such products.
The list of designated serum processing facilities named in the preced -
ing paragraph must be provided by the government of Paraguay, after 
confirming their compliance with Article 5, to the animal quarantine 
authority of Taiwan for approval and publication on its website.
5. The FBS must comply with the following requirements:
5.1 The FBS is derived from bovine fetuses collected from dams that are 
of Paraguay origin.
15.2 The dams have passed ante-mortem and post-mortem inspection by 
the competent authority of Paraguay.
5.3 The sera was extracted by cardiac puncture of the fetus; and then asep -
tically obtained and collected in sterile bags of containers.
5.4 The FBS must be processed in serum processing facilities approved by
the government of Paraguay and the facilities processing sera only 
from the slaughterhouses which have been inspected and passed the 
inspection by the animal quarantine authorit y of Taiwan according to 
the Quarantine Requirements for the Importation of Deboned (chilled 
or frozen) Beef from Parag uay into the Republic of China.
5.5 The FBS has been filtered through filter of 0.22μm or less, or has been
irradiated with γ-ray at the dose of 25 kGray (2.5MRad) or more, and 
has been tested and found free from mycoplasma, bovine viral diar -
rhea, infectious bovine rhinotracheitis, and bluetongue.
6. The consignment must be accompanied by an original veterinary cer -
tificate issued by Paraguay’s competent authority. The certificate must 
specify the following information in English or Chinese:
6.1 Origin:
6.1.1 Name of consignment, total quantity and lot number;
6.1.2 The exporting country;
6.1.3 Name and address of the serum processing facilities; and
6.1.4 Name and address of the exporter.
6.2 Destination:
6.2.1 Country of destination; and
6.2.2 Name and address of the importer.
6.3 Result of the quarantine:
6.3.1 Specify explicitly that the consignment complies with Articles 3 and
5;
6.3.2 Manufacturing date of the consignment.
6.4 Date of issuance, name and official stamp of the issuing authority, and
name and signature of the issuing officer.
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